Global Regulatory Challenges for Medical Devices: Impact on Innovation and Market Access

Abstract

Medical devices play a crucial role in human health. These are instruments, machines or even software programs used to diagnose, treat, monitor or prevent health conditions. They are designed to help improve patients’ quality of life and range from simple items, such as thermometers, to more advanced technologies, such as pacemakers. In order to guarantee the safety and efficacy of medical devices intended for use on patients, the establishment of appropriate regulatory frameworks is crucial to ascertain whether devices function as intended, comply with safety standards and offer benefits that outweigh the associated risks. Depending on the country, different regulatory agencies are responsible for the evaluation of these products. The regulatory landscape for medical devices varies significantly across major markets, including the European Union, the United States of America and Japan, reflecting diverse approaches aimed at ensuring the safety and efficacy of medical technologies. However, these regulatory differences can contribute to a “medical device lag,” where disparities in approval processes and market entry timelines driven by strict regulatory requirements, increasing device complexity and the lack of global harmonization, result in delays in accessing innovative technologies. These delays impact patient access to cutting-edge medical devices and competitiveness in the market. This review aims to address the regulatory framework of medical devices and the approval requirements by the European Commission (EC), the Food and Drug Administration (FDA) and Pharmaceuticals and Medical Device Agency (PMDA).

1. Introduction

In recent years, medical devices have played a crucial role in revolutionizing medicine and improving patient care. They include a broad range of products, such as instruments, apparatuses, equipment and materials used for the diagnosis, prevention, monitoring and treatment of health conditions. Unlike medicines, medical devices act physically or mechanically on the body without chemical interference [1].

The development of medical devices is a complex process that involves several stages, from the initial research and design phase to regulatory validations [2,3,4]. The introduction of medical devices in the market is governed by stringent regulatory frameworks that ensure the products meet safety, efficacy and quality standards. However, the regulatory landscape of medical devices varies significantly across different regions. In this review article, the European Union (EU), the United States of America (USA) and Japan will be the focus, given the global importance of these regions in the medical devices sector. These three markets not only represent some of the largest economies in the world, but they also have advanced regulatory systems that directly influence the practices adopted by other countries, particularly in aspects such as definition and classification, nomenclature, approval procedures and post-market requirements. Differences in such aspects pose both challenges and opportunities for global harmonization, an effort actively pursued by initiatives such as the Global Harmonization Task Force (GHTF) [5] and the International Medical Device Regulators Forum (IMDRF) [6]. Understanding the regulatory frameworks in these major markets is crucial for comprehending the broader dynamics of medical device approval and post-market surveillance, and their associated impacts on innovation and patient care [7,8,9,10].

In the EU, stringent regulations, exemplified by the Medical Device Regulation (MDR), mandate comprehensive pre-market assessments and robust post-market surveillance to ensure patient safety [11]. The Food and Drug Administration (FDA), in the USA, implements a similarly rigorous approval process with distinct protocols for pre-market and post-market phases. These protocols include extensive clinical trials and the continuous monitoring of device performance after market entry [12]. Japan, while a significant player in the global medical device market, faces unique regulatory challenges. The requirements for domestic clinical data and a complex reimbursement system complicate the approval process, leading to notable delays, commonly referred to as “medical devices lag” [13,14,15]. Medical devices lag, characterized by delays in the approval and adoption of new medical devices, arises from stringent regulations, increasing device complexity and challenges in achieving global harmonization [16,17]. The consequences of this are multifaceted, impacting patient access to innovative treatments and affecting market competitiveness. However, various mitigation strategies, including regulatory reforms and harmonization efforts, are being implemented to address these issues [18,19].

This review article aims to clarify the concept of medical devices, detailing their development process and evaluating the current market landscape for these products. In addition, it will explore the regulatory frameworks in major markets such as the EU, the USA and Japan, offering a comprehensive comparison of their regulations. In this context, a concern known as “medical device lag” will also be addressed, focusing on its causes, consequences and how delays in regulatory approval can impact both innovation and patient care. Finally, this article will discuss current initiatives aimed at promoting global regulatory harmonization for medical devices.

2. Methods

To frame this article, a review of the literature was conducted. To identify relevant information, we used the following databases: PubMed/Medline, Research Gate and Science Direct. The search terms incorporated both keywords and controlled vocabulary for the databases used. Some examples of the search terms used included “medical devices regulatory framework”, “medical devices regulation in EU”, “medical devices regulation in US” and “medical devices regulation in Japan”. The search was restricted to the English language and included publications from 2010 to 2024. This timeframe allowed us to understand significant developments in the regulatory standards and guidelines over the last decade, while ensuring the inclusion of the most recent and relevant information regarding the regulation of medical devices.

All regulation documents regarding the approval of medical devices were obtained from the websites of the respective authorities: EMA, FDA and PMDA. Intergovernmental organizations such as the World Health Organization (WHO) and institutions such as the European Commission (EC) were also analyzed to include regulatory guidelines and laws.

Initially, 234 related articles were found. A preliminary review was conducted, where the most relevant articles were considered for the present article. In addition, given the significant changes in European medical device legislation with the introduction of the MDR in 2017, we excluded all the articles discussing European legislation that were published before this date, to ensure that the review would reflect the current regulatory environment and avoid outdated information. After carrying out this process, we obtained 37 articles, which were evaluated and included for their significant contribution to understanding the regulatory frameworks of medical devices in the EU, US and Japan. Figure 1 provides a flowchart of the selection of the reviewed articles.

3. Overview of Medical Devices

3.1. Definition

According to the WHO, a medical device is “any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose” [1]. From this comprehensive definition, it is possible to realize that medical devices encompass a wide range of essential products in the field of medicine and human health.

These products can be used by healthcare professionals and non-healthcare professionals (e.g., patients, relatives, etc.) for various purposes, including diagnosing, preventing, monitoring, treating or alleviating diseases; investigation, monitoring, treating, alleviating or compensating for injuries; investigating, replacing, modifying or supporting anatomy or physiological processes; supporting or sustaining life; controlling conception; disinfecting medical devices; and providing information through the in vitro examination of specimens derived from the human body [20,21]. Figure 2 shows some examples of medical devices according to their respective purpose.

Given the vast variety of medical devices available, it is essential to establish a system to classify these products. Such a system should ensure that products entering the market are clearly identified as medical devices and that they meet the necessary quality and safety standards. This will guarantee that each device can fulfill its intended functions while adhering to the regulatory standards specific to each market [10,22].

The classification of medical devices can be somewhat challenging, given that, depending on its intended purpose, the product may or may not be considered a medical device. Vaseline^® is a good example of this. If it is used as an emollient for healthy skin, it is considered a cosmetic and body care product; if it is used as a laxative, it is considered a medicine; and if it is used as a lubricant during medical procedures, it is considered a medical device [15]. Additionally, products that might be considered medical devices in some jurisdictions but not in others include disinfection substances, aids for persons with disabilities, devices incorporating animal and/or human tissues and devices for in vitro fertilization or assisted reproduction technology [20,21].

3.2. Development Process

The development and manufacture of medical devices is a complex and demanding process that requires precise specifications and high-quality standards to ensure that the final product complies with stringent legal regulations. Furthermore, this process must be meticulously documented to uphold quality and facilitate reproducibility. Several stages are included in this process, as shown in Figure 3, that guide the transition from a conceptual design to a fully functional product ready for use in the medical industry [2,3].

The first stage of medical device development is critical, as it sets the foundation for the entire process. In this stage, the focus is on analyzing the potential opportunities and risks. Initially, it is necessary to identify a medical need or innovation opportunity. Then, it is important to clearly define the intended use of the device to be developed, identify similar products on the market and assess consumer demand and the factors that differentiate the new product. In addition, it is essential to gather users’ needs to direct the design process. At the same time, an initial risk analysis is carried out to understand potential technical and clinical problems that may arise during the rest of the device development process [23,24].

During stage 2, a financial viability analysis is conducted to assess the required investment and potential profit the device can generate. In addition, a formal risk analysis is carried out and the regulatory requirements applicable to the product to be developed are identified. The first prototype is built and serves as proof of concept to demonstrate the practical functionality of the device. This prototype undergoes preliminary safety and effectiveness tests to identify any technical issues and make necessary adjustments to the design. These tests help refine the product concept, which is then detailed, including its functionalities, critical components and the materials required for production [23,24].

The third stage places significant emphasis on creating the design of the device at a more detailed level. The design of the prototype created in the previous phase is rigorously evaluated and validated to ensure that the device fulfils the intended functionality under various conditions and, above all, that it meets the user’s needs. In addition, the design is verified and the prototype is constantly developed and improved to ensure it complies with all relevant regulatory requirements. This stage is critical to guarantee that the product is ready for the next phases of manufacturing and clinical trials [23,24].

In the fourth stage, a final validation of the product is performed. Depending on the class of the device, clinical trials are required to confirm its safety and efficacy in real-world use. It is important to mention that these tests follow strict standards of Good Clinical Practices (GCP). During this period, clinical data is collected and submitted to regulatory agencies that review and analyze the results and, if they are satisfactory, grant approval so that the device can be placed on the market [23].

In the last phase of a medical device’s development, phase 5, after regulatory approval has been obtained and the device has been launched commercially, it is crucial to monitor its performance post-market. This involves collecting feedback from users and ensuring that any problems or faults are resolved quickly. Activities such as post-market surveillance, safety reports and continuous improvements in design and manufacture are carried out to keep the device safe and effective [23,24].

The development process of a medical device can take more or less time, depending on factors such as the complexity of the device and the regulatory requirements. However, this process usually takes longer than a year. The costs inherent in developing a medical device can vary depending on the level of innovation involved and the development timeline, for example and can range from hundreds of thousands to several million dollars [23].

3.3. Medical Devices Market

The global medical device market is primarily driven by increased investment in the sector and favorable regulatory environments for device approval and testing [25]. Regional support for device demand, along with the gradual recovery of the global economy from the pandemic, have also contributed to market growth. Wearable medical devices are gaining popularity among consumers, further increasing market expansion. Key factors, such as advanced product models, innovative features, competitive pricing and intensified marketing efforts by market leaders are expected to expand market growth in the future [25,26].

Consumer lifestyles, an increase in chronic diseases and fewer clinic visits for regular checkups are expanding the market for home monitoring medical devices. Patients are looking for more convenient ways to manage their health, increasing the demand for devices that allow remote monitoring and early detection of health issues [27,28,29]. Additionally, the prevalence of chronic diseases such as hypertension, diabetes and cardiovascular disorders increases the demand for medical devices. Population reliance on ophthalmic and orthopedic devices due to vision and mobility issues also creates new growth opportunities. Increased healthcare facilities and awareness initiatives can also help market growth. However, the high initial costs of medical devices may pose a challenge to market expansion [30,31].

The USA is currently the largest medical device market globally, followed by the EU, with Japan ranking fourth [32]. The Japanese market is poised for further expansion, particularly with the aging population projected to increase from 28% in 2020 to 38% by 2065 [33]. Additionally, North America is expected to lead the global medical device market in terms of revenue until 2026, holding approximately 35% of the market share. This dominance is driven by factors such as the presence of key players, expanding healthcare infrastructure, rapid adoption of advanced medical technologies and a favorable regulatory framework. Meanwhile, in 2026, Europe is forecasted to experience the highest compound annual growth rate, supported by its well-established healthcare system and increasing adoption of advanced diagnostic and treatment devices [26].

As the medical devices market expands, two segments have emerged as particularly noteworthy due to the advances they represent in the healthcare field. These segments are referred to as wearable technology and prosthetic innovation. The wearable technology segment initially included simple equipment such as fitness trackers. However, to meet the increasing demand for preventive health solutions and through the incorporation of advanced technologies like artificial intelligence (AI) and big data, more sophisticated devices are now available, such as continuous glucose monitors that provide real-time data for diabetes management. These new devices enable remote patient monitoring and improve the management of chronic diseases. On the other hand, the prosthetics innovation segment emphasizes the development of highly personalized medical devices, taking advantage of advances in materials science, biomechanics and robotics to produce realistic artificial limbs. An example of a device included in this segment is the 3D-printed prosthesis, which offers personalized adjustments for individual patients [30,31]. Both segments not only exemplify the rapid growth of the medical devices sector, but also emphasize the unique challenges and opportunities they present in meeting the diverse needs of patients.

4. Regulatory Frameworks of Major Markets for Medical Devices

4.1. European Union

With the emergence of medical devices, a regulatory framework has been established to ensure the safety and efficacy of these products’ availability within the Member States. In the EU, the regulation of medical devices is governed by the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, that came into force on 26 May 2021 and lays down strict rules on the safety, traceability and compliance of medical devices in Europe [11]. This regulation repeals the Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices [11].

The main bodies involved in regulating medical devices in Europe are the EC, the competent national authorities, and the Notified Bodies (NBs). The EC plays a crucial role in creating and overseeing the regulations and policies of the EU. It defines the standards that must be followed by medical device manufacturers and works with national authorities and NBs to ensure compliance. The national competent authorities are in turn responsible for overseeing the application of the regulations, ensuring that medical devices comply with the regulations in their respective countries. In addition, these authorities are also responsible for market surveillance, investigating incidents related to medical devices and taking appropriate action. Finally, NBs are independent organizations designated by EU member states to carry out conformity assessments of medical devices. They certify that the devices meet the requirements of European regulations before the devices can receive the Conformité Européenne (CE) marker, which is required to market the device in Europe [34,35,36].

In addition to these organizations, the European Medicines Agency (EMA) also plays a role in regulating medical devices. The EMA is a decentralized EU agency responsible for the scientific evaluation, supervision and safety monitoring of medicines developed by pharmaceutical companies for use in the EU [34]. Although the EMA is primarily focused on medicines, it also plays a role in regulating medical devices that are combined with medicines or considered high-risk [37].

4.1.1. Definition and Classification

According to Article 2 of Regulation (EU) 2017/745, the term “medical device” refers to ‘’any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: —diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, —diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability, —investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, —providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices: —devices for the control or support of conception; —products specifically intended for the cleaning, disinfection or sterilization of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.’’ [11].

In the EU, medical devices are classified into several classes, such as class I (Isp, Imf and Irs), class II (IIa, IIb) and class III, according to their intended purpose and intrinsic risks [11,22]. Class I devices are considered low risk and non-invasive, and are admitted as everyday devices or appliances. In this category, we can also consider the Class Isp that includes sterile medical devices, the Class Imf that includes devices with a measuring function and the Class Irs that includes reusable surgical instruments. Class II devices are classified as Class IIa when they are considered low to medium risk and refer mainly to devices installed within the body for a short term, or as Class IIb when they are slightly more complex than class IIa devices. Class IIb devices are generally medium to high risk and often include devices installed within the body for longer periods. Lastly, Class III devices are strictly high-risk devices and for this reason, they follow a more rigorous process for market introduction [38].

4.1.2. Market Authorization

In order to be marketed in the EU, medical devices must undergo a marketing authorization process to ensure that the devices meet stringent EU requirements, ensuring that they meet the safety, efficacy and quality standards set by the relevant regulations before they can be made available to consumers [39,40].

The review and authorization of medical devices is carried out by designated NBs that ensure compliance with Regulation (EU) 2017/745. This process requires manufacturers to prepare and submit a dossier containing specific information, such as the device’s general description, technical specifications, risk management documentation, pre-clinical and clinical tests results, labelling and a post-marketing surveillance plan [40].

• CE Marking

The CE marking is a mandatory requirement for selling medical devices within the Economic European Area (EEA). It plays a crucial role by certifying that these products meet all relevant EU regulations and directives and allows the free movement of products within the EEA. For manufacturers, obtaining the CE mark is a crucial legal requirement for entering the European market. For consumers, it means that the product has undergone rigorous conformity assessments, ensuring its safety and compliance with European standards [29,30]. Marking medical devices with the CE symbol follows the general principles outlined in Article 30 of Regulation (EC) No 765/2008 and must be visibly, legibly and indelibly applied to the device or its sterile packaging [41,42,43].

The NBs are the entities responsible for authorizing the application of the CE marking, issuing conformity certificates and making decisions regarding their renewal or withdrawal [22,34]. They ensure that manufacturers comply with their obligations, cooperate with national authorities and collaborate with other NBs across EU member states. If applicable, the CE marking must be followed by the identification number of the NB responsible for conformity assessment procedures [35].

Obtaining a CE mark involves several key steps, from identifying the applicable regulations for the product to affixing the CE marking, as shown in Figure 4. During this process, the manufacturer must follow a rigorous conformity assessment procedure to ensure compliance with these regulations.

The first step is to determine which EU regulations and directives apply to the specific product and carefully analyze and understand the requirements that apply to it, as these requirements are the basis for ensuring product conformity. The next step is to select the appropriate conformity assessment route for the product [42,43]. Depending on the classification class of the medical device, manufacturers must choose from several conformity assessment procedures, with NB involvement being mandatory for higher-risk devices [39].

The first procedure is the Quality Management System (QMS) and technical documentation. It is used when manufacturers implement a full QMS, covering all aspects of device development, from design to manufacturing and final inspection. NBs thoroughly assess and approve these systems to ensure compliance with regulatory standards. This process is typically used for higher-risk devices. Another procedure is the EC-Type Examination, where the NB examines a representative sample of the device to ensure it meets the essential requirements specified in the MDR. This involves rigorous evaluation and testing of the device’s design to confirm it complies with the regulation’s safety and performance standards. This procedure is commonly used for devices with more complex risk profiles. Then, there is the Product Conformity Verification composed of two procedures: product quality assurance and product verification. In the first one, NBs evaluate the manufacturer’s production processes to ensure consistent compliance with the regulation. This includes ongoing surveillance and audits of the QMS to maintain adherence to regulatory standards over time. In the second one, NBs inspect and test individual batches of devices to confirm that the manufactured products are consistent with technical documentation and comply with regulatory requirements. This is often used when batch-by-batch verification is necessary due to the device’s nature or risk [45,46].

For Class I devices, manufacturers are only required to present technical documentation before affixing the CE marking. For Class Isp, Ims and Irs devices, the process involves limited intervention from a NB for the assessment procedure. Manufacturers have the option to submit the technical documentation with product quality assurance or with limited QMS. Moderate-risk devices, like Class IIa and IIb devices, must undergo one of the conformity assessment procedures involving a NB. This is crucial to ensure these devices meet the EU’s stringent regulatory requirements. For Class IIa devices, manufacturers can choose from the present technical documentation with full QMS, with product quality assurance or with product verification. For Class IIb devices, the available routes are to present the Technical Documentation with full QMS, or to perform an EC-Type Examination with product quality assurance or product verification. Finally, for Class III Devices, characterized as high-risk, manufacturers must opt for conformity assessment procedures that involve a NB. They can choose to present the technical documentation with full QMS, or to perform an EC-Type Examination with product quality assurance or with product verification if they opt not to follow the first procedure [45,47].

After the most suitable procedure has been chosen, the product is rigorously assessed to ensure that it fulfils the essential requirements. This can involve internal assessments and external tests carried out by accredited laboratories or both, taking into account the conformity assessment route chosen previously. All the data obtained through this assessment, as well as the processes, design choices and test results that demonstrate the product’s compliance with the essential requirements must be compiled in a technical dossier. Finally, the Declaration of Conformity (DoC) is drafted and signed and the CE symbol can be applied to the product and on its packaging. This means that the product is ready to be introduced and commercialized on the European market [45,47].

• Unique Device Identification

The Unique Device Identification (UDI) system is a standardized identification mechanism designed to enhance the traceability and monitoring of medical devices within the EU. Introduced under Regulation (EU) 2017/745, the UDI system aims to improve patient safety and simplify the management of medical devices throughout their lifecycle. It represents a comprehensive approach to enhancing the traceability, safety and regulatory compliance of medical devices within the EU, aligning with international standards and promoting efficient healthcare management [11].

The UDI must be placed on the device label or on its packaging, ensuring it is visible and easily identifiable. It is an alphanumeric code that includes standardized information, enabling the unique identification of each medical device in the market. It consists of two parts: the UDI Device Identifier (UDI-DI) and the UDI Production Identifier (UDI-PI). The UDI-DI includes details about the manufacturer and the device model, which remain consistent across all devices of the same model. When multiple individual units of a medical device are packed together in a larger box or container, each higher level of packaging must possess its own UDI-DI, except for shipping containers, which are exempt from this requirement [48,49]. The UDI-PI contains information specific to each unit of device production, such as the serial number, batch number, manufacturing and/or expiration date and software identifier. This part of the code varies for each individual unit produced [49]. Figure 5 provides an example of an UDI in the EU.

• European Database on Medical Devices

The European Database on Medical Devices (EUDAMED) is a comprehensive electronic system established and managed by the EC. It was created to enhance transparency, traceability and coordination in the regulation of medical devices across the EU [48,50].

EUDAMED was designed to provide public access to comprehensive information on all medical devices available in the EU market. This includes details on certificates issued by NBs and information concerning relevant economic operators. The database facilitates the unique identification and traceability of devices within the internal market. Furthermore, EUDAMED informs the public about clinical investigations and assists sponsors in meeting regulatory requirements. It also aids manufacturers in fulfilling their obligations regarding reporting on serious incidents and field safety corrective actions. Overall, EUDAMED supports competent authorities in EU Member States and the EC by facilitating regulatory tasks and fostering cooperation among them [43,50,51].

EUDAMED consists of several interconnected electronic systems, as shown in Figure 6, including actor registration, which allows economic operators to submit the information necessary to obtain an actor identifier or a single registration number. UDI/Device registration is used for registering medical devices. Notified Bodies and Certificates is where NBs should register any information regarding the certificates issued. Clinical investigations and performance studies are used for managing information on clinical investigations. Vigilance and post-market surveillance monitors adverse events and other safety issues and lastly, market surveillance oversees market compliance and enforcement actions [51].

4.1.3. Post-Market Surveillance

Article 83 of Regulation (EU) 2017/745 outlines the requirements for the post-market surveillance system [11]. Manufacturers must establish and maintain a system proportional to the device’s risk class, integrated into their QMS. This system actively collects, records and analyzes relevant data on device quality, performance and safety throughout its lifecycle. The data collected is used for various purposes, including updating benefit–risk assessments, improving risk management and identifying preventive or corrective actions when necessary. Manufacturers must inform relevant authorities when corrective actions are needed [43,52].

Article 85 of Regulation (EU) 2017/745 mandates that manufacturers of Class I devices produce a post-market surveillance report summarizing results and conclusions, including details of any preventive or corrective actions taken [11]. Manufacturers of Class IIa, IIb and III devices must also produce periodic safety reports, updating them annually for Class IIb and III devices and as needed for Class IIa devices. For Class III and implantable devices, manufacturers must submit safety reports to the NBs participating in the conformity assessments, while for other devices, reports are provided to the relevant NBs and competent authorities upon request [43,52].

This comprehensive framework ensures the ongoing monitoring of medical devices’ safety and performance post-commercialization, facilitating the timely identification and management of any issues that may arise [11].

Table 1. Medical devices’ classification and regulatory requirements in EU.

Class	Sub-Class	Definition	Pre-Market	Post-Market
I	I	Low risk	Technical documentation	Post-market surveillance report
	Isp	Sterile device	Technical documentation with Product quality assurance OR Technical documentation with limited QMS
	Imf	Measuring device
	Irs	Reusable surgical instruments
II	IIa	Low–medium risk Devices installed within the body in the short term	Technical documentation with full QMS OR Technical documentation with Product quality assurance OR Technical documentation with product verification	Periodic safety reports (as needed)
	IIb	Medium–high risk Devices installed within the body for longer periods	Technical documentation with full QMS OR EC-type examination with Product quality assurance OR EC-type examination with Product verification	Periodic safety reports (annually)
III	-	High risk	Technical documentation with full QMS OR EC-type examination with Product quality assurance OR EC-type examination with Product verification	Periodic safety reports (annually)   AND   Safety reports submission to NB

provides an overview of the classification and regulatory requirements pre- and post-market for medical devices in the EU.

4.2. United States of America

In the USA, the regulation of medical devices falls under the jurisdiction of the Food and Drug Administration (FDA) [12]. The approval and oversight process for these products is governed by the Federal Food, Drug and Cosmetic Act (FFDCA) [53].

4.2.1. Definition and Classification

A medical device is defined by the FDA as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is recognized in the official National Formulary, or the USA Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes’’ [12].

The FDA classifies medical devices into three classes based on the level of risk they pose to patients and the necessity of regulatory controls to ensure their safety and effectiveness [54]. Class I devices are those that do not support or sustain life and do not present a potential unreasonable risk of illness or injury. These devices are considered to be of low risk. They are subject to the least regulatory control and must comply with general controls, which include provisions such as proper branding, labelling and adherence to Good Manufacturing Practices (GMP) [54,55]. Class II devices are considered to be of moderate risk. General controls alone are insufficient in assuring safety and effectiveness, so they need to be subject to additional regulatory controls called special controls. These controls may include performance standards, post-market surveillance, patient registries and guidance documents. Lastly, Class III devices are those that support or sustain human life, are of substantial importance in preventing the impairment of human health or which present a potential unreasonable risk of illness or injury. These devices are subject to the highest level of regulatory control, including pre-market approval (PMA), which requires evidence providing a reasonable assurance of the device’s safety and effectiveness [54,55].

4.2.2. Market Authorization

All medical devices are subject to basic regulatory requirements known as general controls, which provide a reasonable assurance of a device’s safety and effectiveness. As the risk associated with a device increases, additional regulatory requirements, such as special controls and premarket approval, are implemented [55,56].

Section 510(k) of the FFDCA is a regulatory pathway used by the FDA to clear medical devices for market entry by demonstrating substantial equivalence to a legally marketed predicate device. This process requires manufacturers to show that their new device has the same intended use and technological characteristics as a predicate device, or that any differences do not raise new questions of safety and effectiveness. The 510(k) process begins with the submission of a detailed application to the FDA. This application includes a description of the device, identification of the predicate device, an explanation of the intended use and a comparative analysis of the technological characteristics of the predicate device [56,57].

To expedite reviews for certain modifications, the FDA offers two alternatives to traditional submission 510(k): special 510(k) and abbreviated 510(k) pathways. These two forms were introduced to simplify and speed up the approval process for medical devices. Special 510(k) applies to modifications of a manufacturer’s own legally marketed device, allowing for a more efficient review process for changes that do not affect the device’s intended use or fundamental technology. Abbreviated 510(k) utilizes FDA guidance documents, special controls, or consensus standards to demonstrate substantial equivalence, thereby streamlining the review process [57]. Figure 7 compiles the three types of 510(k) submissions, as well as when each pathway should be used.

For devices that do not have a substantially equivalent predicate device, manufacturers can pursue the de novo classification pathway, where the FDA conducts a thorough review to evaluate the device’s risks and benefits. This process is crucial for introducing innovative technologies or devices into the market that do not fit existing classifications [58]. The outcome of this review determines the device’s risk classification (Class I, II or III). If classified as Class I or II, the device can be marketed immediately and may serve as a predicate device for future 510(k) submissions, enabling similar devices to follow a streamlined approval process. As mentioned, special controls are additional regulatory requirements imposed on Class II devices to enhance their safety and effectiveness. These controls can include performance standards, post-market surveillance, patient registries, special labelling requirements, pre-market data requirements and specific guidelines tailored to the device type [55,59].

The PMA is the most rigorous pathway for FDA approval, focusing extensively on demonstrating the safety and effectiveness of the device through comprehensive scientific evidence. This includes detailed documentation of both administrative aspects and scientific research. The submission must adhere to strict regulations outlined in the FDA’s framework, covering non-clinical research such as microbiology, toxicology and biocompatibility, as well as clinical research encompassing study protocols, safety data and patient outcomes. Consequently, manufacturers must meticulously prepare their PMA applications to address all regulatory requirements and scientific criteria. The failure to meet these standards can result in the denial of the PMA, effectively inhibiting the device from being marketed in the USA [55,60].

Class I devices are subject to the least stringent requirements due to their perceived low risk [22]. These devices are not subjected to special controls and have no specific requirements. They are exempt from Pre-Market Notification (510(k) submission) and only need to comply with basic regulatory requirements, known as general controls [55,56]. Class II devices require more than general controls to ensure safety and effectiveness. To enter the market, these devices typically go through the 510(k) process, demonstrating substantial equivalence to a legally marketed predicate device. This involves submitting detailed information to the FDA [59]. If no predicate exists, the de novo classification pathway allows for a thorough FDA review to determine the device’s classification [58]. Special controls and the 510(k) process together ensure that Class II devices meet all the necessary standards before being marketed [55,59]. Introducing Class III medical devices into the USA market involves stringent regulatory processes overseen by the FDA. Unlike Class I and Class II devices, which may be cleared through the 510(k)-pathway based on substantial equivalence to predicate devices, Class III devices require PMA [56,57,60].

• Unique Device Identification

The Unique Device Identification (UDI) system, established by the FDA Amendments Act of 2007 and further defined by the Food and Drug Administration Safety and Innovation Act of 2012, plays a crucial role in identifying and tracking medical devices throughout their lifecycle [61]. Each device has a distinct UDI alphanumeric code containing standardized information, allowing the formal identification of each device and giving access to detailed data in the Global Unique Device Identification Database (GUDID) [34,44,61,62]. Figure 8 provides an example of an UDI in the USA.

The UDI Rule, finalized in September 2013, mandates that manufacturers include the UDI on device labels and packages. For devices requiring multiple uses and reprocessing, the UDI must also be marked directly on the device. The information associated with UDIs, such as device attributes, production identifiers and Global Medical Device Nomenclature (GMDN) codes, is submitted to the FDA and enters the GUDID. This database serves as a comprehensive reference system that is accessible to the public, enhancing transparency and facilitating the better integration of device information into healthcare data systems [55,63].

This UDI system aims to enhance transparency and facilitate better integration into healthcare data systems, with its objectives including reducing medical errors, improving traceability and enabling effective post-market surveillance. By standardizing device identification and providing comprehensive information through the GUDID, the FDA supports patient safety and regulatory oversight [64].

4.2.3. Post-Market Surveillance

The FDA’s pre-market review process serves as an essential step in ensuring the safety of medical devices before they reach the market [65]. However, a robust post-market surveillance system is also essential to monitor device safety during clinical use and facilitate corrective actions like updating labelling, enhancing user training or removing devices from the market when issues arise [66]. The FDA’s post-market surveillance includes mandated studies, adverse event reporting (or passive surveillance) that relies on unsolicited reports of adverse events from manufacturers, users, importers and active surveillance in real-world settings, which involves proactively collecting and analyzing data from large healthcare systems to verify or detect safety signals [55,67].

Passive surveillance mechanisms like the Medical Device Reporting (MDR) system identify significant adverse events and involves distinct reporting requirements for manufacturers, user facilities and importers. In 2014, the FDA mandated electronic Medical Device Reporting (eMDR) to expedite access to adverse event information, although user facilities may still submit paper MDR reports [68,69].

Active surveillance studies, such as post-market studies, such as “522 studies” and Post-Approval Studies (PAS), address gaps in pre-market data and respond to safety concerns. The FDA’s 522 Post-Market Surveillance Studies program encompasses responsibilities for designing, tracking, overseeing and reviewing studies mandated under section 522 of the FFDCA to ensure they are conducted effectively, efficiently and with a simple approach [70]. The goal is to collect data that can uncover unforeseen adverse events or other critical information necessary to protect public health and answer surveillance questions. The PAS are mandatory for device approval and sponsors must employ valid scientific methodologies in study design and conduct these studies effectively, efficiently and with minimal burden. Failure to comply with any post-approval requirements may lead to the FDA’s withdrawal of approval [67,70].

Table 2. Medical devices’ classification and regulatory requirements in USA [54].

Class	Definition	Pre-Market	Post-Market
I	Low Risk	General Controls	Medical Device Reporting (Applicable to All Classes)   522 studies   (Applicable mainly to Class II and III)   Post-Approval Studies (Applicable to All Classes)
II	Moderate Risk	510(k) Submission Special Controls
III	High Risk	Pre-Market Approval (FDA Approval)

presents a compilation of the classification and regulatory requirements pre- and post-market for medical devices in the USA.

4.3. Japan

Medical devices in Japan are regulated under the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (PMD Act) by the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Device Agency (PMDA). This act, oversees the quality, efficacy and safety of medical devices by classifying them based on the level of risk they pose to users [13,71].

4.3.1. Definition and Classification

According to the PMD Act, medical devices are “appliances or instruments”, etc. which are intended for use in the diagnosis, treatment or prevention of disease in humans or animals, or intended to affect the structure or functioning of the bodies of humans or animals (excluding regenerative medicine products) and which are specified by Cabinet Order’’ [13].

The classification of medical devices is essential in determining the level of regulatory control required [72]. General Medical Devices, classified as Class I, require self-declaration by the manufacturer. In these devices, an approval of the product is not necessary, but a marketing notification is required [72]. Controlled Medical Devices, classified as Class II, require certification by a registered certification body. The certification criteria are reviewed and approved by the MHLW, with guidance provided in review guidelines [72]. Higher-Risk Medical Devices, classified as Class III and Class IV, require approval by the MHLW following a review by the PMDA. The approval criteria and review guidelines are established to ensure the safety and efficacy of these devices [72].

4.3.2. Market Authorization

In Japan, the regulatory process for medical devices varies depending on their classification and associated risks [73]. To facilitate the regulatory review process, the MHLW issues comprehensive review guidelines that provide manufacturers with detailed insights into the major technical requirements, acceptance criteria and evaluation criteria employed by regulatory authorities. While these guidelines do not give specific performance limits, they play a crucial role in promoting a more efficient and transparent review process. By adhering to these guidelines, manufacturers can simplify the regulatory approval process and expedite the entry of their medical devices into the Japanese market [74,75].

The Self-Declaration Process applies to the lowest risk devices. In this process, the manufacturers must submit a DoC to the PMDA. This declaration asserts that the device complies with relevant regulatory standards. While there is no formal review by regulatory authorities, adherence to these standards is mandatory to ensure the safety and efficacy [73].

Third-Party Certification, which is required for controlled risk devices, involves certification by independent organizations registered by the MHLW. These certification bodies evaluate the device’s design, manufacturing processes and quality control measures to ensure compliance with established standards for quality, efficacy and safety [72]. They also notify the MHLW of certification decisions, ensuring transparency and accountability in the certification process. The process where there is an MHLW’s Approval and it is reviewed by the PMDA is mandatory for higher-risk devices. The PMDA oversees this process, evaluating devices against specific approval criteria. These criteria are often based on international standards such as ISO or IEC, ensuring a thorough assessment of device safety, efficacy and quality. The PMDA’s rigorous evaluation aims to protect public health by ensuring that medical devices meet stringent regulatory requirements before entering the market [72].

Class I device’s manufacturers undergo the self-declaration process, submitting a DoC to the PMDA to assert compliance with regulatory standards. This process emphasizes self-certification with mandatory adherence to ensure device safety and efficacy [72]. For class II devices, a third-party certification is required. Certification bodies evaluate the device’s design, manufacturing practices and quality controls to certify compliance with standards for quality, efficacy and safety. Transparency is ensured through reporting to the MHLW [72]. Class III and IV devices need approval from the MHLW, reviewed by the PMDA. The PMDA evaluates these devices against specific approval criteria, often aligning with international standards. This stringent evaluation ensures devices meet rigorous safety, efficacy and quality standards before market entry [72].

• Japanese Medical Device Nomenclature

The Japanese Medical Device Nomenclature (JMDN) is a standardized system used to identify medical devices in Japan. It was created based on the 2003 version of the GMDN and was implemented in 2005 [14,72].

Each medical device is uniquely identified by an eight-digit JMDN code. Codes starting with 1, 3, or 4 are based on GMDN, while those starting with 7 are unique to JMDN. The first five digits are derived from the GMDN code, with an additional three digits appended to form the JMDN code. If the last three digits are 000, it means the GMDN is not subdivided. The first of the three added digits indicate the presence of biological materials or drug substances. The second digit reflects no differences in risk classification, but there may be minor differences in the device. The third digit indicates the differences in risk classification [72]. Figure 9 provides a comprehensive outline of the JMDN code, along with some examples.

The JMDN is not updated simultaneously with the current GMDN. The MHLW creates new JMDN codes by referring to the current GMDN when a medical device does not fit any existing JMDN. This system ensures that medical devices in Japan are categorized and identified in a standardized manner, facilitating regulatory processes and ensuring consistency with international standards where applicable [72].

4.3.3. Post-Market Surveillance

The post-market surveillance of medical devices in Japan is a comprehensive system designed to ensure the ongoing safety and effectiveness of these products after they have been approved for use [76]. Initially, manufacturers must monitor and report any adverse occurrences linked to their medical devices to regulatory bodies, like MWLH. These incidents encompass device malfunctions and adverse reactions arising during device utilization. Moreover, regulatory bodies regularly revise regulations and guidelines pertaining to medical devices to address emerging safety concerns and technological advancements. This ensures manufacturers’ compliance with prevailing regulatory standards [76].

Manufacturers are further obliged to establish and execute risk management systems to detect, evaluate and mitigate potential risks associated with their medical devices. This entails conducting comprehensive risk assessments and implementing corrective measures as necessary to address any safety concerns. Periodic regulatory inspections are undertaken to validate adherence to GMP standards and other regulatory mandates. These assessments serve to uphold the quality, safety and efficacy of medical devices manufactured in Japan [76].

Effective communication among manufacturers, regulatory authorities, healthcare practitioners and patients is indispensable for sustaining post-market surveillance. This involves sharing information regarding safety updates, issuing recalls or corrective measures when needed and encouraging information exchange to facilitate informed decision-making.

Table 3. Medical devices’ classification and regulatory requirements in Japan.

Class	Definition	Pre-Market	Post-Market
I	General medical devices	Self-declaration process	Regulatory oversight revision   Risk management system   Periodic regulatory inspection
II	Controlled medical devices	Third party certification OR Minister’s approval (review by PMDA)
III/IV	High-risk medical devices	Minister’s approval (review by PMDA)

provides an overview of the classification of medical devices and the regulatory requirements pre- and post-market in Japan.

5. Comparison and Global Challenges of Medical Device Regulations

The regulatory framework in the medical device’s major markets (i.e., Europe, USA and Japan) differ significantly. However, each one is tailored with the main objective of guaranteeing the safety, effectiveness and innovation of medical devices. Recognizing the regulatory differences between these markets is essential to ensure compliance with local requirements, since each region has specific rules governing product approval, safety and quality. In this way, companies launch their medical devices efficiently and safely, meeting the needs of each market. Legal problems and launch delays are also avoided.

5.1. Comparative Analysis of Medical Device Regulations across Major Markets

When comparing the regulatory frameworks for medical devices across the EU, USA and Japan, several similarities and differences emerge. All three of these regions classify medical devices based on risk, with varying classifications dictating the level of regulatory scrutiny. Each region mandates compliance with specific regulatory controls: CE marking and NB oversight in the EU, FDA clearance or approval in the USA and PMDA approval in Japan. Post-market surveillance is a common requirement across all of these regions, focusing on monitoring device performance, safety reporting and regulatory updates [11,12,13].

However, notable differences exist. The EU’s regulatory framework emphasizes decentralized procedures overseen by NBs and integration them through EUDAMED for transparency and traceability [11,51]. Additionally, the fact that the EU is a union of several countries introduces significant complexity into its regulatory system compared to the US and Japan. Although all the EU countries operate under the same regulations, variations can arise in their interpretation and application. The USA system, overseen by the FDA, incorporates a structured classification into three risk-based classes with pathways like 510(k) and PMA, coupled with stringent adherence to the Current GMP for consistent quality control [12,57,60]. In Japan, the system is characterized by rigorous evaluation processes by the PMDA, alongside adherence to the JMDN for device classification [72].

There are deadlines set by the regulatory authorities for the review of medical devices, which tend to extend with the complexity and risk level of the device. However, these deadlines are not strictly fixed and can vary due to various factors, such as delays resulting from requests for additional information or the current workload of the regulatory authorities.

Overall, while each region prioritizes device safety and efficacy through distinct regulatory approaches, they converge in their commitment to ensuring public health and facilitating market access for medical innovations.

Table 4. Comparison of medical devices’ legislation between regions.

Region	Europe	USA	Japan
Authority	European Commission (Medical Device Coordination Group) Notified Bodies National Authorities European Medicines Agency	United States Food and Drug Administration (Center for Devices and Radiological Health)	Ministry of Health, Labour and Welfare Pharmaceuticals and Medical Devices Agency
Regulation	Regulation (EU) 2017/745	Federal Food, Drug and Cosmetic Act de 1938 and subsequent amendments	Pharmaceuticals and Medical Devices Act
Classification	Class I, Isp, Imf, Irs, IIa, IIb and III Based on Their Intended Purpose and Intrinsic Risk	Class I, II and III Based on the Level of Risk They Pose to Consumers	Class I, II, III and IV Based on the Level of Risk Posed by the Device
Identification System	Unique Device Identification	Unique Device Identification	Japan Medical Device Nomenclature
Pre-Market	Declaration of Conformity Conformity Assessment Conducted by a Notified Body	510(k) Special Controls Pre-Market Approval	Self-Declaration Third Party Certification Minister’s Approval (Review by Pharmaceuticals and Medical Devices Agency)
Post-Market	Post-Market Surveillance Report Periodic Safety Reports	Medical Device Reporting 522 studies Pos-Approval Studies	Regulatory Oversight and Revision Risk Management System Periodic Regulatory Inspections

provides a comparison of medical devices legislation across the major markets.

5.2. Japan’s Medical Devices Lag: A Global Challenge in the Medical Devices’ Market

The medical device lag in Japan is a current global challenge. It refers to delays in the approval and adoption of new medical devices, stemming from various regulatory processes and other factors between Japan and the EU/USA [11]. Initially, this lag was substantial, reaching nearly 3 years in the early 2000s [18]. However, efforts have been undertaken to address this issue, resulting in gradual improvements over time. This phenomenon can occur at multiple stages, including pre-market approval, post-market surveillance or reimbursement processes [77].

Medical device lag stems from several key factors, including stringent regulatory frameworks that vary between countries. While these standards are crucial for patient safety, they can also lead to delays in approving new and innovative medical technologies [78]. Another significant contributor to medical device lag is the increasing complexity of modern medical devices [19]. As technology advances, devices become more intricate, incorporating sophisticated functionalities and materials. This complexity poses challenges to existing regulatory systems, which must adapt and expand their evaluation processes to adequately assess these advanced technologies. Consequently, the time required for regulatory approval and market entry often extends due to the need for more thorough evaluations and assessments [10,78].

Furthermore, global harmonization issues compound medical device lag. Variations in regulatory requirements across different countries create barriers that hinder the simultaneous global introduction of new devices. Although there is an ongoing initiative that aims to promote the convergence and alignment of regulatory practices, achieving full harmonization remains an ongoing challenge [79].

The impact of medical device lag is multifaceted. Firstly, it limits patient access to innovative and potentially life-saving medical technologies. Delays in the approval process mean that patients may have to wait longer for new treatments that could significantly improve their health outcomes. Medical device lag also affects market competitiveness. Manufacturers facing prolonged approval processes may find it challenging to compete with the in regions with faster regulatory systems. This can hinder technological advancements in the healthcare industry and reduce the incentive for innovation [80].

To mitigate medical device lag, several strategies have been proposed and implemented. One of the key approaches is harmonization efforts. Collaborative initiatives strive to harmonize global regulations and simplify approval processes, reducing the time it takes for new devices to reach the market [77,78]. Regulatory reforms are also essential. Continuous updates and reforms to regulatory frameworks are necessary to adapt to the evolving landscape of medical technology. These reforms can help reduce approval timelines and improve the efficiency of the regulatory process [78].

6. Global Harmonization Initiatives for Medical Devices

Considering the differences in the regulatory framework for medical devices across various markets and the medical device lag that results from these disparities, it is essential to attempt to harmonize these procedures. Initiatives that aim for global regulatory harmonization are crucial, as they try to simplify international trade, reduce compliance costs and accelerate the introduction of new innovative products on the market. Additionally, by establishing common standards for safety and efficacy, these initiatives promote a more efficient and predictable regulatory environment, ultimately benefiting manufacturers, regulators and patients alike.

6.1. The Global Harmonization Task Force

The Global Harmonization Task Force (GHTF) was one of the first major global initiatives to promote the harmonization of medical device regulations. Originally formed by representatives from five founding members from the EU, the USA, Canada and Japan, the GHTF was an international working group with representatives from the regulated industry and from the medical device regulatory authorities [81,82]. Its goal was to standardize regulatory approaches for ensuring the safety, efficacy and quality of medical devices, through the development and distribution of unified guidance documents across different regulatory frameworks [82]. This was achieved in September of 1992, when representatives from Europe, Asia-Pacific and North America met in France to investigate the possibility of forming a global consultative partnership. This gave rise to a working framework a few months later and resulted in the organization’s inaugural meeting as the GHTF at the beginning of 1993. The GHTF was discontinued in 2012. However, its guidelines and principles continue to influence current regulations and have paved the way for subsequent initiatives [81].

6.2. International Medical Device Regulators Forum

The International Medical Device Regulators Forum (IMDRF) was established in 2011 by its founding members, including regulatory authorities from Australia, Brazil, Canada, China, the EU, Japan, the USA and the WHO [6]. Their objective was to further expedite international harmonization and convergence in medical device regulations [81]. However, it was not until February 2012 that the IMDRF was officially launched, marked by its inaugural meeting in Singapore [81]. This event initiated the transition from the GHTF to the IMDRF, continuing the mission to harmonize regulatory approaches and ensure the safety, efficacy and quality of medical devices globally [6].

The IMDRF aims to promote the sharing of best practices, to support innovation and to facilitate global trade of medical devices. They provide guidance for countries with developing regulatory systems to gather insights from established frameworks, ultimately contributing to the advancement of global health standards [6].

7. Conclusions

Medical devices are essential equipment in the health sector. These are any devices used to diagnose, treat, prevent or mitigate medical conditions. Their complexity can vary based on their function and purpose, the technology involved, their interaction with the human body and the associated risk. These products undergo a very demanding development process to ensure the final device meets the desired standards for safety, efficacy and quality.

Over the last few years, the medical devices market was characterized by intense competition and a wide diversity of innovative products and has experienced significant growth. Before being placed on the market, medical devices must be evaluated by the competent regulatory authorities to guarantee that they meet legal requirements. These evaluations are fundamental to ensuring that the devices are suitable for use on patients. The regulatory framework for medical devices differs significantly across the major markets (i.e., EU, USA and Japan). Each region has established robust regulatory systems tailored to its unique healthcare landscape and regulatory philosophy. Despite their differences, all three regions share a commitment to safeguarding public health through stringent regulatory controls, which, while crucial for patient safety, also contribute to challenges in the medical devices’ market. One of these challenges in the Japan’s medical devices lag, which consists of delays in the approval and adoption of new medical technologies, hindering patient access to innovative treatments and impacting market competitiveness. Efforts to address medical device lag include global regulatory harmonization initiatives that aim for streamline approval processes, reduce regulatory discrepancies and promote faster global market access for innovative medical devices. The GHTF and the IMDRF are two crucial organizations, among others, that contributed to this harmonization.

The future of medical devices is very promising. It is expected that, by integrating fields of computer science, such as AI, machine learning and robotics, the accuracy of diagnoses and treatments will be improved. Connected devices enable real-time remote monitoring, allowing the tracking of patient conditions, and intervene more quickly. In addition, it will become increasingly common for devices to be customized to suit the individual needs of each patient, promoting precision medicine. Lastly, the economic impact of these devices will also be significant, with the expectation of reduced costs and greater accessibility. However, the need for the global harmonization of regulations will continue to be a challenge.

Overall, this study aimed to elucidate the regulatory frameworks for medical devices in the EU, the US and Japan. Despite their differences and challenges, these regions share a common goal of protecting patients’ health through rigorous evaluation processes, which serve as the foundation for ongoing improvements in medical device standards. There is still much to be explored on this topic, as the future of medical devices looks promising and predicts a significant impact on the health sector, both in terms of availability and innovation.