1. Understanding the Term “Legacy Devices” Under EU MDR
Definition of Legacy Devices under EU MDR
Under the European Union Medical Device Regulation (EU MDR 2017/745), “legacy devices” refer to medical devices that were lawfully placed on the market under the previous regulatory frameworks—the Medical Device Directive (MDD 93/42/EEC) or the Active Implantable Medical Devices Directive (AIMDD 90/385/EEC)—before the MDR became fully applicable on 26 May 2021, and which continue to be made available or put into service during the transitional period. These devices are not certified under MDR but maintain valid MDD or AIMDD certificates. They are allowed to stay on the EU market temporarily, provided they continue to meet certain conditions set by the MDR.
Legal Basis and Transition Provision
The status of legacy devices is specifically addressed in Article 120 of the MDR, which outlines the transitional provisions for such devices. It allows manufacturers to continue placing legacy devices on the market until the expiration of their MDD/AIMDD certificates, provided they have not undergone significant design or intended purpose changes. This provision was designed to prevent sudden market disruptions and to give manufacturers time to adapt to the stricter MDR requirements. It is also tied to compliance with other MDR chapters related to post-market surveillance, vigilance, and registration, which apply to all legacy devices during the transition period.
Certification Status and Expiry
Legacy devices retain their MDD or AIMDD certificates only for a limited duration. Initially, the transition period was set to end by May 2024, but due to implementation challenges, the European Commission extended the deadlines through Regulation (EU) 2023/607. Now, depending on the device class, legacy devices can remain on the market until December 2027 or December 2028, as long as specific conditions are met—such as submitting an MDR application to a Notified Body by May 2024 and having a quality management system in place. Once these certificates expire, the devices must either be fully compliant with MDR or be withdrawn from the market.
Scope of Legacy Devices
Not all medical devices automatically qualify as legacy devices. The term applies primarily to Class I devices that have been up-classified under MDR, and Class IIa, IIb, and III devices that were previously certified under MDD/AIMDD and now fall under stricter MDR scrutiny. Class I devices that do not require NB involvement under MDR (e.g., non-measuring, non-sterile) were required to comply fully with MDR starting from May 2021 and are not considered legacy devices. The scope also excludes devices that have undergone significant design modifications or intended purpose changes since their original certification, as such changes invalidate their legacy status.
Regulatory Obligations for Legacy Devices
While legacy devices are not MDR-certified, they are still subject to several key MDR requirements. These include obligations related to post-market surveillance (PMS), vigilance reporting, registration in EUDAMED (where applicable), and compliance with the general safety and performance requirements (GSPRs) as far as possible. Manufacturers must maintain technical documentation, clinical evidence (if available), and a structured plan for eventual MDR compliance. Failure to meet these obligations during the transition period could lead to market withdrawal, regulatory penalties, or reputational damage.
Strategic Implications for Manufacturers
Managing legacy devices under EU MDR presents both operational and strategic challenges for manufacturers. Many are forced to evaluate whether continuing legacy device production is commercially viable, especially when certification costs, time constraints, and clinical data requirements are considered. As a result, companies often prioritize high-volume or high-margin devices for MDR transition and withdraw low-demand or niche products, impacting product availability. Strategic planning, early engagement with Notified Bodies, and rigorous internal audits are critical to ensure a smooth transition and uninterrupted market access for essential devices.
Legacy Devices refer to:
- Medical devices that were certified under the old Medical Device Directive (MDD 93/42/EEC) or Active Implantable Medical Device Directive (AIMDD 90/385/EEC),
- And are still on the market during the transitional period, without MDR certification,
- But continue to comply with previous directives under strict conditions (Article 120 of EU MDR 2017/745).
These devices can remain available until their certificates expire, but no significant design or intended purpose changes are allowed.
2. MDR vs. MDD: Increased Stringency
Clinical Evaluation Requirements
Under the Medical Device Directive (MDD), clinical evaluation often relied heavily on literature review and equivalence-based reasoning, especially for Class I and Class IIa/b devices. This meant that if a manufacturer could show that a similar device was already on the market and had a good safety record, new clinical data was often not required. In contrast, the EU Medical Device Regulation (MDR) imposes far stricter requirements. Manufacturers must now provide detailed clinical data for all risk classes (except some Class I) and must include clinical performance data gathered from clinical investigations or robust post-market surveillance. Equivalence claims must be scientifically justified and can only be made if the manufacturer has access to the full technical documentation of the compared device—making equivalence nearly impossible unless both products are owned by the same company.
Risk Classification Rules
MDR introduces a more nuanced and risk-based classification system that reclassifies many devices into higher-risk categories. For example, software that influences clinical decision-making, which was often considered Class I under MDD, is now frequently classified as Class IIa or higher under MDR. Similarly, certain surgical instruments and reusable Class I devices are now treated as Class IIa, requiring notified body involvement. The new rules account for invasiveness, duration of use, and interaction with the body more rigorously, which results in a significant number of devices needing upgraded conformity assessments and re-certifications under more stringent conditions.
Post-Market Surveillance and Vigilance
Under MDD, post-market surveillance (PMS) and vigilance requirements were minimal, with limited expectations around proactive safety monitoring. MDR completely overhauls this by requiring manufacturers to implement a continuous PMS system, including the development of PMS plans, Periodic Safety Update Reports (PSURs), and trend reporting. For higher-risk devices, manufacturers must perform and document Post-Market Clinical Follow-up (PMCF) studies to continuously validate safety and performance. This shift transforms PMS from a reactive process to a proactive, data-driven responsibility, requiring new infrastructure, digital tools, and budget allocation.
Notified Body Oversight and Engagement
During the MDD era, the designation and oversight of Notified Bodies (NBs) were decentralized and inconsistently enforced across EU Member States. This led to variability in how strictly regulations were interpreted and applied. MDR introduces a much more stringent framework for the designation and operation of NBs, subjecting them to rigorous reassessment and oversight by the European Commission and national authorities. Notified Bodies must meet enhanced competency requirements, perform unannounced audits, and rigorously review technical documentation. As a result, many former MDD Notified Bodies have exited the market, reducing capacity and increasing competition among manufacturers for certification slots.
Technical Documentation and Labeling
MDR mandates a significant increase in the quantity and quality of technical documentation required to support a device’s safety and performance claims. This includes detailed design dossiers, clinical evaluation reports, risk management files, and updated instructions for use. MDR also introduces a Unique Device Identification (UDI) system to enhance traceability and product lifecycle transparency. Labels must now include UDI-DI, traceability information, and in many cases, must be translated into multiple EU languages. These enhanced requirements increase the workload on regulatory and labeling teams and necessitate early planning for compliance.
Transparency and EUDAMED
Under the MDD framework, there was no centralized system to publicly track medical devices, manufacturers, or vigilance reports. MDR addresses this gap by introducing the European Database on Medical Devices (EUDAMED), which aims to bring full transparency to the European device market. EUDAMED will centralize data on devices, economic operators, clinical investigations, vigilance, market surveillance, and certificates. Once fully implemented, it will enable patients, healthcare professionals, and regulators to track device performance and post-market incidents more efficiently. Though not yet fully operational, the expectation of EUDAMED compliance has already increased documentation and IT system requirements for manufacturers.
| Aspect | MDD | MDR |
|---|---|---|
| Clinical Evaluation | Literature-based, less stringent | Requires clinical data, real-world evidence, PMCF |
| Classification | Less granular | Stricter risk-based rules, many up-classified devices |
| PMS & Vigilance | Limited obligations | Enhanced PMS and PMCF with mandatory plans and reports |
| Notified Body Oversight | Lax and inconsistent | Rigorous audits, reduced number of NBs |
| Transparency | No centralized database | Introduction of EUDAMED, UDI, and labeling requirements |
| Scrutiny | Rare for Class IIb/III | High scrutiny especially for implantables and software |
3. Current Transition Timeline (Post-Amendment Regulation 2023/607)
Background of the Transitional Provision Update
The original Medical Device Regulation (EU) 2017/745, which came into force on May 26, 2021, introduced stricter requirements for the certification of medical devices in the European Union. However, by early 2023, it became clear that both manufacturers and notified bodies were facing significant challenges in meeting the transition deadlines, particularly due to the complex technical documentation, increased clinical evidence requirements, and a shortage of designated notified bodies. In response to these systemic bottlenecks and to avoid potential shortages of essential medical devices, the European Commission adopted Regulation (EU) 2023/607 on March 20, 2023. This amendment extended the transition timelines for legacy devices certified under the former Directives (MDD and AIMDD) under certain conditions.
Conditions for Eligibility for Extended Transition
The extended transitional periods are not automatic. For a legacy device to remain on the market under the extended timelines, the following key conditions must be met: (1) the device must have a valid certificate issued under the MDD or AIMDD as of 26 May 2021, (2) the device must not have undergone any significant changes in its design or intended purpose after that date, and (3) the manufacturer must have implemented a quality management system compliant with MDR Article 10(9). Additionally, by May 26, 2024, manufacturers must have lodged a formal application for MDR conformity assessment with a notified body and concluded a written agreement with that body before the applicable deadline. Failing to meet these conditions disqualifies the device from the extended grace period.
Staggered Transition Deadlines by Device Class
The amended Regulation 2023/607 introduced staggered transition deadlines based on the risk classification of the device. For Class III and certain Class IIb implantable devices, the new deadline for obtaining MDR certification is 31 December 2027. For other Class IIb devices (non-implantables), Class IIa, and up-classified Class I devices, the deadline has been extended to 31 December 2028. Devices falling under Class I that were not up-classified by MDR were never eligible for extended timelines and were required to comply with MDR from the original date—26 May 2021.
No Blanket Extension for All Requirements
It is important to note that the extension granted by Regulation 2023/607 does not relieve manufacturers from all MDR obligations. While the conformity assessment deadlines have been extended, manufacturers must still comply with several critical MDR requirements regardless of whether the device is fully certified. These include implementing MDR-compliant post-market surveillance (PMS), vigilance, market surveillance cooperation, UDI requirements, and registration obligations in line with Articles 93–100 of MDR. Additionally, these legacy devices must be clearly labeled and tracked to distinguish them from fully MDR-certified products.
Implications for Notified Bodies and Stakeholders
This staggered extension was also intended to ease the burden on notified bodies, which have been overwhelmed with conformity assessment applications under the MDR. Despite this, challenges remain, as the number of MDR-designated notified bodies is still limited, and the volume of certifications required far exceeds current capacity. The regulatory change also gives manufacturers more time to compile complex technical documentation, conduct clinical evaluations, and adapt to post-market surveillance and vigilance systems. However, failure to act early—such as delaying submission of MDR applications—could still result in last-minute rejections or loss of market access by the extended deadlines.
| Device Class | MDR Certification Deadline |
|---|---|
| Class III & IIb implantables | 31 December 2027 |
| Class IIb (non-implantables), IIa, I (sterile/measuring) | 31 December 2028 |
| Class I (non-upclassified) | Already under MDR |
Note: Manufacturers must comply with PMS, vigilance, and registration obligations regardless of deadline.
4. Real Consequences for Legacy Devices
Market Withdrawal and Loss of Product Lines
One of the most immediate and tangible consequences of the EU MDR on legacy devices has been the widespread market withdrawal of products that were previously certified under the MDD or AIMDD. Many of these devices, especially those with low sales volume or narrow clinical application, are no longer economically viable to transition to MDR due to the cost and complexity of recertification. As a result, manufacturers have chosen to discontinue such devices altogether. This includes not only outdated models but also highly functional and widely used devices that no longer meet the new evidence standards or classification requirements. The loss of these devices can significantly reduce therapeutic options available to clinicians.
Economic Burden on Manufacturers, Especially SMEs
The MDR’s increased documentation requirements, enhanced clinical evaluation obligations, and more stringent conformity assessment procedures have imposed a substantial economic burden on medical device manufacturers. This impact is particularly acute for small and medium-sized enterprises (SMEs), many of which lack the internal regulatory infrastructure or financial capacity to support MDR transition activities. These companies often have diverse but low-volume product portfolios, making it financially impractical to invest in MDR certification for each legacy device. Consequently, SMEs are being pushed out of the EU market or forced to scale down significantly, leading to reduced competition and innovation.
Disruption in Patient Care and Access to Devices
The withdrawal of legacy devices from the market has created gaps in clinical care, especially in cases where alternative devices are unavailable or not clinically equivalent. Patients suffering from rare diseases or requiring specific implantable devices are particularly vulnerable, as these often involve niche products that are less likely to be recertified under MDR. In many hospitals, physicians report reduced availability of trusted legacy systems, which forces them to switch to unfamiliar alternatives that may require different surgical techniques or training. This transition has also led to increased instances of postponed procedures, higher costs for alternative solutions, and potential compromises in treatment quality.
Regulatory Bottlenecks and Notified Body Constraints
The MDR has significantly increased the workload for Notified Bodies, while simultaneously reducing their number compared to the MDD era. This mismatch has created severe bottlenecks in the certification process, causing long delays even for manufacturers who are willing and prepared to transition legacy devices. In some cases, the lack of timely access to a Notified Body has resulted in legacy devices reaching their certificate expiration without MDR replacement, leading to sudden market withdrawal. These delays also deter innovation, as manufacturers are reluctant to invest in new clinical studies or product development without assurance of regulatory approval within a reasonable timeframe.
Stockpiling and Supply Chain Challenges
To mitigate the risk of losing essential legacy devices, hospitals and distributors have begun stockpiling available units prior to their de-certification. While this offers short-term relief, it introduces long-term problems, such as increased risk of product expiration, storage complications, and regulatory liability if expired products are used in patient care. Furthermore, supply chain uncertainties—particularly for imported components or sterile packaging—have been exacerbated by the MDR’s stricter traceability and labeling rules. This has disrupted logistics planning and contributed to localized shortages of specific medical technologies across the EU.
Declining Innovation and Delay in Technology Uptake
The rigorous and resource-intensive requirements of the MDR have made Europe a less attractive market for launching new medical devices, particularly for startups and tech-driven companies working on digital health or AI-based diagnostics. These firms often lack the capital and clinical history needed to support the new MDR demands, leading them to prioritize markets like the U.S. (FDA pathway) or Australia. As a result, EU patients are experiencing delays in accessing cutting-edge technologies, and the region is losing its competitive edge in medical device innovation. This shift is especially noticeable in fast-evolving segments such as wearable health monitors and software as a medical device (SaMD).
A. Market Withdrawal of Non-Compliant Devices
- Tens of thousands of devices are being voluntarily withdrawn from the EU market, especially low-margin or low-volume legacy devices.
- Many manufacturers, especially SMEs, cannot afford MDR recertification, which involves:
- Cost: €100,000–€500,000+
- Time: 12–18 months for NB review (in ideal conditions)
⚠️ Example: A 2024 MedTech Europe survey found that 33% of manufacturers discontinued some devices due to MDR barriers.
B. Access Disruption to Essential and Niche Medical Devices
- Devices for rare diseases, pediatrics, or older implant models (e.g., bone plates, pacemaker leads) are being phased out.
- Consequences include:
- Limited choice for clinicians
- Therapy disruption for patients dependent on specific implants
- Delays in treatment due to product unavailability
❗ Case Study: Several orthopedic implant providers ceased older screw and plate systems, creating surgical limitations in trauma care.
C. Stockpiling and Shortages
- Hospitals are stockpiling legacy devices before certificates expire.
- However, shelf-life and sterilization limitations may cause:
- Expired inventory
- Legal liability for healthcare providers
- Supply chain unpredictability
D. Shift in Innovation Pipeline
- Companies are reducing EU-first launches due to MDR complexity.
- FDA, Australia (TGA), and UK (MHRA) are becoming preferred markets due to faster, less burdensome pathways.
- This delays new technology access in the EU.
🧠 Example: AI-driven diagnostic devices or novel cardiac implants now reach U.S. markets 1–2 years earlier than in EU.
E. Strain on Notified Bodies and Approval Bottlenecks
- Only 45 Notified Bodies designated under MDR (compared to over 80 under MDD).
- Review timelines increased due to:
- More documentation
- Higher expectations
- Risk-based scrutiny
🔄 Result: Even compliant legacy devices face delays in transition → market gaps.
5. Impact on Patient Care Access
Limited Availability of Specialized and Niche Devices
One of the most significant consequences of EU MDR is the reduced availability of specialized legacy medical devices, particularly those intended for niche markets such as pediatric care, rare diseases, and elderly patients. Due to the high cost and regulatory burden of MDR compliance, many manufacturers have opted not to recertify devices that serve small patient populations or yield low profit margins. These withdrawals have led to gaps in the availability of essential treatment tools, forcing healthcare providers to either substitute less optimal alternatives or forego certain procedures altogether. For instance, pediatric-specific implants and devices for rare metabolic disorders are increasingly difficult to procure within the EU.
Disruption in Continuity of Care for Existing Patients
Many patients who were implanted with or prescribed specific legacy devices under MDD are facing care disruptions. As older devices are phased out, compatible components, accessories, or replacement parts are no longer available. This is especially problematic in cases involving implanted cardiac or orthopedic devices that require long-term maintenance or upgrades. Surgeons and clinicians are now being compelled to switch patients to newer systems or refer them to centers outside the EU, raising concerns about patient safety, treatment continuity, and ethical responsibilities in transitioning care.
Increased Treatment Delays and Surgical Challenges
The discontinuation of legacy surgical instruments and implant systems has introduced significant delays in planned surgical procedures. Hospitals are often left with a reduced inventory of compatible tools or must source alternative technologies that require new training or logistical adjustments. Surgeons accustomed to specific legacy systems are facing steep learning curves, and in some cases, are delaying operations until suitable replacements are procured and approved. These changes not only extend surgical wait times but can also increase risks during intervention due to unfamiliarity with new systems.
Growing Inequities in Healthcare Access
The MDR’s effects on legacy devices have disproportionately impacted public hospitals, rural care facilities, and economically constrained regions within the EU. These institutions often lack the resources or procurement flexibility to adapt quickly to market withdrawals. As a result, healthcare inequalities are widening between larger urban hospitals that can afford new MDR-certified devices and smaller centers that must rely on outdated or insufficient technology. In some cases, patients in underserved areas are being referred to external providers or even foreign countries to access necessary treatments.
Psychological and Financial Stress on Patients
For patients dependent on long-term devices—such as insulin pumps, implantable pain management devices, or assistive technologies—the disappearance of familiar models has created psychological stress and financial strain. Many fear that if their devices malfunction or require upgrades, no suitable options will be available. Additionally, where legacy devices are replaced by newer MDR-compliant alternatives, patients are often required to bear additional costs for re-evaluation, adaptation, or retraining. This change undermines trust in the healthcare system and raises broader concerns about patient-centric care in a heavily regulated environment.
Shift Toward Off-Label Use and Workarounds
In an attempt to continue providing care, some healthcare professionals are resorting to the off-label use of available devices or adapting older devices beyond their certified usage period. While these practices may be driven by necessity, they pose serious medico-legal and ethical challenges. Without explicit regulatory guidance, clinicians risk liability, while patients may receive care that lacks full regulatory assurance. This emerging trend highlights the urgent need for flexible regulatory pathways or conditional exemptions for critical legacy devices.
| Patient Domain | Impact |
|---|---|
| Implants (orthopedic, cardiac) | Discontinuation of long-established models; surgeons forced to re-train on new systems |
| Rare disease therapies | Lack of alternative devices in EU; medical tourism or import reliance increasing |
| Children’s health | Pediatric-specific models dropped due to low volume/cost of recertification |
| Elderly care | Legacy monitoring and support devices phased out; limits on home healthcare |
| Diagnostics | Older diagnostic devices withdrawn; labs need costly replacements |
6. Industry and Regulator Response
Regulatory Extensions and Transitional Relief
To prevent disruption in the availability of essential medical devices, the European Commission introduced Regulation (EU) 2023/607, which extended the transitional period for legacy devices. This regulation allowed devices certified under the previous Medical Device Directive (MDD) or Active Implantable Medical Device Directive (AIMDD) to remain on the market until December 2027 or 2028, depending on their risk class, provided they continue to meet specific conditions such as no significant changes and ongoing compliance with surveillance requirements. This extension was a direct response to overwhelming industry concerns about the unfeasible timelines for MDR certification, particularly in light of limited Notified Body (NB) capacity.
Increase in Notified Body Designations and Capacity Building
One of the most significant bottlenecks in the MDR transition has been the insufficient number of Notified Bodies designated under the new regulation. As a corrective measure, the EU has actively encouraged more conformity assessment bodies to apply for designation, and several new NBs have been approved since 2022. Additionally, existing NBs have expanded their staff and resources to increase review capacity. However, these improvements have only gradually reduced the backlog, and the system remains under strain, especially for high-risk device classifications. Regulators have also introduced guidance to standardize NB expectations and improve transparency during audits and technical documentation assessments.
Guidance Documents and Harmonization Efforts
To help manufacturers navigate the complexity of MDR, the European Commission, along with the Medical Device Coordination Group (MDCG), has released over 100 guidance documents. These cover clinical evaluation requirements, post-market surveillance, equivalence justifications, and transitional provisions for legacy devices. While these documents have clarified certain ambiguities, industry stakeholders still call for more consistency and harmonization across Notified Bodies. There have also been collaborative initiatives with international regulatory authorities such as the U.S. FDA and Australia’s TGA to promote convergence and reduce duplicate efforts for global manufacturers.
Support for Small and Medium Enterprises (SMEs)
SMEs, which make up a significant portion of the medical device industry in Europe, are particularly vulnerable under MDR due to limited financial and regulatory resources. Recognizing this, some national regulatory authorities and industry associations have launched support programs. These include funding grants, regulatory training, and access to subsidized consulting services. Nonetheless, the majority of SMEs report challenges in affording the costs of clinical studies, technical file redevelopment, and notified body fees. The European Commission has acknowledged these issues but has not yet implemented a centralized SME support mechanism under MDR.
Digitalization and EUDAMED Development
A cornerstone of MDR implementation is the European Database on Medical Devices (EUDAMED), intended to increase transparency, traceability, and public access to device information. While development has been slower than expected, three of the six modules—actor registration, vigilance, and device registration—are live as of 2025. The industry has welcomed this progress but remains concerned about the delays in full implementation. Many stakeholders are also investing in digital compliance solutions to manage documentation, Unique Device Identification (UDI), and post-market surveillance in anticipation of EUDAMED’s mandatory use in the near future.
Industry Adaptation and Strategic Portfolio Management
Faced with rising regulatory costs and approval delays, many medical device companies have begun restructuring their portfolios. They are focusing on fewer, higher-revenue devices that justify the investment required for MDR compliance, while phasing out low-volume or niche legacy products. Larger corporations are integrating regulatory affairs functions more deeply into their product development cycles, while smaller firms are increasingly turning to third-party consultants and contract research organizations (CROs) for support. Industry groups such as MedTech Europe have also intensified lobbying efforts to propose pragmatic solutions to regulators, including faster review pathways for low-risk or essential-use legacy devices.
A. Regulatory Flexibility
- Amendment (EU) 2023/607 extended certification deadlines to prevent shortages.
- Ongoing discussions around:
- Easing low-risk legacy device certification
- Centralizing some approvals (e.g., orphan devices)
B. Risk Mitigation by Hospitals
- Strategic procurement of alternative suppliers
- Use of equivalent devices or off-label applications (controversial)
- Increased training for new systems
7. Comparative View – EU MDR vs Global Regulatory Impact
European Union (EU MDR)
The European Union’s Medical Device Regulation (EU MDR 2017/745) represents one of the most comprehensive and stringent regulatory frameworks in the world for medical devices. Its aim is to increase patient safety, traceability, and clinical oversight through strict requirements for clinical evidence, post-market surveillance, and transparency via EUDAMED. However, this has led to considerable strain on manufacturers, especially for legacy devices. Many companies have withdrawn products from the EU market due to the high cost and complexity of compliance, compounded by limited notified body availability. As a result, the EU is facing real challenges in device availability and patient care continuity, especially for low-volume and niche devices. The MDR has unintentionally caused market exits, slower innovation, and delayed access to new technologies within Europe.
United States (FDA)
In contrast, the United States Food and Drug Administration (FDA) maintains a relatively balanced approach between patient safety and innovation, primarily through the 510(k) premarket notification process for most moderate-risk devices. This pathway allows devices to be cleared based on “substantial equivalence” to previously approved products, providing manufacturers with a quicker and more cost-effective route to market compared to EU MDR. While the FDA has also increased post-market surveillance and real-world evidence initiatives, it continues to support innovation through programs like the Breakthrough Devices Program and the Digital Health Software Precertification Program. The U.S. regulatory environment is currently more predictable and business-friendly, making it an attractive first-launch region for many device developers.
United Kingdom (MHRA)
The United Kingdom, post-Brexit, has developed its own regulatory system under the MHRA, moving toward the UKCA (UK Conformity Assessed) marking system. While initially retaining elements of the EU’s MDD/MDR framework, the MHRA is seeking to create a more flexible, agile system with faster approvals and international alignment (especially with FDA and other IMDRF members). However, the regulatory pathway is still evolving, with transitional measures currently in place through 2028. The UK is experiencing moderate impact on legacy devices, and many manufacturers are still using CE-marked devices in the UK under grace periods. Nonetheless, the long-term direction suggests a more innovation-friendly regime compared to the EU, albeit with challenges around dual compliance and regulatory divergence.
Canada (Health Canada/MDSAP)
Canada operates through Health Canada and leverages the Medical Device Single Audit Program (MDSAP), which streamlines auditing across multiple jurisdictions including the U.S., Australia, Brazil, and Japan. This system enables a more efficient compliance pathway for global manufacturers. Canadian regulations are relatively pragmatic, with a focus on quality management systems and post-market vigilance. For legacy devices, the burden is lower compared to the EU MDR, and fewer manufacturers have reported withdrawing from the Canadian market. The Canadian environment supports a smoother transition for device updates and portfolio management, maintaining both access and regulatory control without overburdening industry players.
Australia (TGA)
Australia’s Therapeutic Goods Administration (TGA) aligns closely with international standards, including reliance on European CE marking for many products. However, it is now gradually moving toward a more independent and risk-based regulatory model. While TGA has adopted elements of post-market surveillance and clinical data expectations similar to MDR, it has retained flexibility in the approval of legacy and low-risk devices. The regulatory burden is notably less than that of the EU, allowing manufacturers to maintain legacy products with fewer disruptions. The TGA also participates in MDSAP, which further eases the compliance process for companies operating globally.
Global Summary and Strategic Insights
Globally, the EU MDR stands out as the most demanding regulation in terms of clinical documentation, risk classification, and device traceability, especially for legacy products. Other jurisdictions like the U.S., UK, Canada, and Australia are maintaining or evolving toward more balanced systems that prioritize both safety and innovation. The disparity in global regulatory approaches is causing manufacturers to reassess market strategies, often prioritizing entry into the U.S., Canada, or Australia before tackling the EU. This divergence risks leaving EU patients behind in terms of timely access to medical technology, especially in emerging fields like digital health, diagnostics, and rare disease devices.
| Region | Legacy Device Handling | Patient Access Risk |
|---|---|---|
| EU (MDR) | Very strict; legacy devices losing certification | High |
| US (FDA 510(k)) | Continued use based on substantial equivalence | Low |
| UK (MHRA) | Developing new UKCA regime; some MDD-like flexibility | Moderate |
| Canada (MDSAP) | Integrated auditing allows smoother transitions | Low |
8. Strategic Recommendations
Manufacturers: Optimize Portfolios and Engage Early with Notified Bodies
Manufacturers facing MDR transition challenges must act decisively by performing early gap analyses and initiating the conformity assessment process well in advance of deadlines. Legacy devices should be categorized based on commercial viability, risk class, and regulatory complexity. Companies are encouraged to rationalize their product portfolios, discontinuing low-demand or marginally profitable devices to focus resources on core, high-value offerings. Engaging proactively with notified bodies is essential, as appointment slots are limited and review timelines remain long. Preparing comprehensive and MDR-compliant technical documentation—including updated Clinical Evaluation Reports (CER), Post-Market Surveillance (PMS), and Post-Market Clinical Follow-Up (PMCF) plans—is crucial to securing timely approvals.
Hospitals and Clinics: Plan Procurement and Ensure Clinical Continuity
Healthcare providers must anticipate potential disruptions in device availability due to legacy device withdrawal or certification delays. This includes conducting risk assessments of current device inventories, identifying alternatives, and stockpiling essential legacy products where legally and logistically feasible. Hospitals should initiate early procurement planning and collaborate with suppliers to understand device certification status. In cases where replacement devices are introduced, comprehensive staff retraining should be scheduled to ensure seamless patient care. Clinics treating rare conditions or pediatric patients should advocate for access to equivalent devices or participate in clinical programs that can support continued use of discontinued models under controlled conditions.
Policy Makers: Support Regulatory Flexibility and Transparency
Regulatory authorities in the EU must consider extending targeted flexibility measures to preserve patient access while maintaining safety standards. This may include streamlined certification pathways for low-risk or niche legacy devices that are critical for specific patient groups. Policymakers should invest in expanding the designation and capacity of notified bodies to relieve bottlenecks in the certification pipeline. Additionally, accelerated development and enforcement of the full EUDAMED database would improve traceability, public confidence, and cross-border device tracking. Incentivizing innovation-friendly, risk-based regulation, particularly for SMEs, is vital to sustaining a diverse and resilient medical device ecosystem.
Consultants and Regulatory Professionals: Enable Compliance Through Expertise
Clinical research organizations (CROs), regulatory consultants, and notified body liaisons can play a pivotal role in assisting manufacturers—especially small and mid-sized enterprises—in navigating the complex MDR landscape. By offering end-to-end support in compiling technical files, generating compliant clinical evidence, and preparing regulatory submissions, these professionals reduce both risk and workload for in-house teams. Additionally, third-party experts often bring insights into changing regulatory interpretations, notified body expectations, and post-market requirements, which can improve approval success rates. Their involvement is especially critical for companies lacking dedicated regulatory affairs departments.
Cross-Industry Collaboration: Advocate and Educate
Medical technology companies, healthcare providers, and patient advocacy groups should foster dialogue with EU regulators to ensure that the consequences of the MDR are fully understood and addressed. Industry associations such as MedTech Europe are instrumental in lobbying for proportionate regulation and providing consolidated feedback to the European Commission. Furthermore, knowledge-sharing platforms, regulatory roundtables, and collaborative innovation hubs can help stakeholders remain informed and aligned with MDR updates. Educating end-users—including physicians and procurement departments—on regulatory changes and product availability is essential for patient-centered continuity of care.
- Manufacturers:
- Early engagement with NBs, gap analysis, and design dossier updates.
- Streamline portfolios: Focus on high-impact, profitable devices.
- Partner with CROs or RA consultants for CER, PMS, and PMCF.
- Hospitals & Clinics:
- Inventory forecasting and cross-border procurement.
- Advocacy with regulators for essential-use exemptions.
- Staff training on alternative technologies.
- Policy Makers:
- Implement special pathways for low-risk legacy devices.
- Expand Notified Body designations and resources.
- Prioritize EUDAMED completion and harmonization with FDA/IMDRF.
References
[1] European Parliament and Council of the European Union, Regulation (EU) 2017/745 on Medical Devices (EU MDR), Apr. 2017. [Online]. Available: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745
[2] European Commission, Q&A on the implementation of Regulation (EU) 2023/607 amending Regulation (EU) 2017/745, Mar. 2023. [Online]. Available: https://health.ec.europa.eu/system/files/2023-03/md_mdr-transition-guidance_qna_en.pdf
[3] European Commission, Medical Devices – MDCG Guidance Documents, 2021–2025. [Online]. Available: https://health.ec.europa.eu/system/files/2024-02/md_mdcg_guidance_en_0.pdf
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