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Revision of the MDCG 2021-25 Guide: What Medical Device Manufacturers need to know

Medical devices regulation

Medical device regulations are constantly evolving to ensure the safety and effectiveness of products in the European market. In this context, the MDCG 2021-25 guide, published by the Medical Device Coordination Group (MDCG), is an essential document for manufacturers managing the transition of their legacy devices towards compliance with the Regulation (EU) 2017/745 (MDR). This guide was recently updated with Revision 1, released on October 16, 2024, providing important clarifications and adjustments to the requirements.


This revision is crucial for all industry players as it extends the transition periods for certain devices until 2027 or 2028, while introducing clarifications on key aspects such as the management of procedure packs and Quality Management System (QMS) requirements. In this article, we will explore the changes brought by this update and what it means for medical device manufacturers.




1. Context of the Revision


The Regulation (EU) 2017/745 (MDR), which replaced the previous Directives 90/385/EEC and 93/42/EEC, significantly transformed the regulation of medical devices in Europe. Its goal is to enhance patient safety and strengthen the oversight of devices placed on the European market. The regulation, which took effect on May 26, 2021, marked a major turning point for manufacturers, obliging them to comply with stricter requirements.


However, many medical devices had already been placed on the market under the old directives before this date, known as “legacy devices”. For these devices, a transition period was introduced to allow manufacturers to gradually adapt to the new MDR rules while ensuring that these products could continue to be sold within the European Union.


The MDCG 2021-25 guide, initially published in October 2021, was designed to help manufacturers during this transition by clarifying the application of MDR requirements to legacy devices. The document addressed obligations related to post-market surveillance, risk management, and the declaration of conformity.


In October 2024, Revision 1 was published to incorporate new provisions introduced by Regulation (EU) 2023/607, which extended the transition period for certain devices until 2027 and 2028. This update also answers many questions raised by manufacturers, providing additional clarifications on key points such as the exemption from the declaration of conformity (Article 19), QMS requirements, and the application of rules to systems and procedure packs.


This revision thus responds to the sector’s need for adaptation while ensuring a clear and rigorous regulatory framework for bringing legacy devices into compliance with the MDR.




2. What Is a Legacy Device?


The term “legacy device” refers to a medical device that was placed on the market before the Regulation (EU) 2017/745 (MDR) came into effect but continues to be sold during the transition period without being fully compliant with the new MDR requirements. These devices were initially compliant with the previous European directives, particularly Directive 90/385/EEC (for active implantable medical devices) and Directive 93/42/EEC (for medical devices).


A legacy device can be one of the following types: Class I devices under Directive 93/42/EEC, for which a declaration of conformity was issued before May 26, 2021, and which now require a notified body’s involvement to be compliant with the MDR. Devices covered by a valid CE certificate issued under Directives 90/385/EEC or 93/42/EEC before May 26, 2021.


It is important to note that these devices are not fully compliant with the MDR but can continue to be sold until specific deadlines (extended to 2027 or 2028, depending on the risk class) as long as they meet certain transitional requirements. These requirements include no significant changes to design or intended use, as well as the implementation of post-market surveillance, risk management, and regulatory compliance measures.


On the other hand, “old devices” are those that were placed on the market before May 26, 2021, and are no longer subject to the new MDR requirements after their initial placement on the market. However, old devices remain under the supervision of competent authorities to ensure they do not pose an unacceptable risk to patient safety.


Finally, MDR devices are distinguished from legacy devices by being fully compliant with the MDR’s requirements. These devices must meet all new obligations concerning safety, performance, and technical documentation from the moment they are placed on the market.


In summary, the transition period for legacy devices allows manufacturers to continue selling their products while preparing for full MDR compliance, a process that requires careful adaptation to the new rules.




3. Key Points of Revision 1 (October 2024)


Revision 1 of the MDCG 2021-25 guide, published on October 16, 2024, introduces several important changes compared to the initial 2021 version. These changes are primarily driven by the adoption of Regulation (EU) 2023/607, which extended the transition deadlines for legacy devices and provided clarifications to facilitate the application of the MDR’s new requirements. Here are the key points to remember:



1. Extension of Transition Deadlines

One of the main updates in Revision 1 is the extension of the transition deadlines for legacy devices:

  • Class III devices and certain Class IIb implantable devices can continue to be marketed until December 31, 2027.
  • Class IIa devices, other Class IIb devices, and Class I devices that are sterile or have a measuring function can be marketed until December 31, 2028.

This extension gives manufacturers more time to fully comply with MDR requirements, particularly regarding technical documentation and notified body evaluations.



2. Clarification on the Exemption of Article 19 (Declaration of Conformity)

Revision 1 clarifies that Article 19 of the MDR, which concerns the Declaration of Conformity, does not apply to legacy devices. This means that manufacturers of legacy devices do not need to update their declaration of conformity according to MDR requirements but must continue to comply with the previous directives (90/385/EEC or 93/42/EEC) under certain conditions.



3. New Rules for Systems and Procedure Packs

The revision provides important clarifications regarding the application of transitional provisions to systems and procedure packs containing legacy devices. These systems can continue to be marketed during the transition period, provided they do not include devices that already require full MDR compliance. The guide explains how to manage these systems based on the risk level of the most critical device.



4. Quality Management System (QMS) Requirements

Revision 1 reiterates that all manufacturers of legacy devices must have implemented a Quality Management System (QMS) compliant with Article 10(9) of the MDR by May 26, 2024. This QMS does not need to be certified before that date, but it must cover key aspects such as post-market surveillance, risk management, and traceability. This requirement is crucial to ensuring the quality and safety of devices during the transition period.



5. Post-Market Surveillance and Risk Management

Post-market surveillance and risk management obligations remain a fundamental pillar of the MDR requirements for legacy devices. Manufacturers must ensure that their surveillance systems are robust and include the collection, analysis, and management of incidents related to the use of legacy devices. The revision reiterates the importance of Periodic Safety Update Reports (PSUR) and audits by notified bodies.




4. Comparison Between Revision 0 and Revision 1


Revision 1 of the MDCG 2021-25 guide introduces several significant modifications compared to Revision 0, published in 2021. These changes aim to integrate recent regulatory developments and clarify certain aspects of the transition framework for legacy devices towards compliance with the Regulation (EU) 2017/745 (MDR).


Here are the main differences between the two versions of the guide:



1. Extension of Transition Deadlines

In Revision 0, the transition deadlines for legacy devices were set for May 26, 2024. Revision 1 brings a major change by extending the transition periods to December 31, 2027 for Class III devices and certain Class IIb devices, and to December 31, 2028 for Class IIa devices, other Class IIb devices, and Class I devices that are sterile or have a measuring function.


This extension gives legacy device manufacturers more time to prepare for MDR compliance.



2. Clarifications on Article 19 and the Declaration of Conformity

In Revision 0, the exemption of Article 19 concerning the declaration of conformity for legacy devices was not clearly established. Revision 1 now explicitly clarifies that Article 19 does not apply to legacy devices, meaning that manufacturers of these devices do not need to update their declaration of conformity according to MDR requirements. However, they must continue to comply with the previous directives (90/385/EEC or 93/42/EEC).



3. Structural Adjustments and Removal of the Preface

Revision 0 included a Preface explaining the creation of an ad hoc task force by the MDCG and the steps involved in the development of the guide. This preface has been removed in Revision 1, for the sake of simplification and to harmonize the guide with the standard structure of MDCG documents. Additionally, several adjustments were made to the structure of the document to improve clarity and content coherence.



4. Systems and Procedure Packs

A new and important clarification introduced in Revision 1 concerns systems and procedure packs. The revision specifies how legacy devices integrated into these systems or packs should be managed during the transition period. In Revision 0, these aspects were not as detailed, and there was a need for clarity on how to apply transitional provisions to these combinations of devices.



5. Strengthened Requirements for the Quality Management System (QMS)

Revision 1 places greater emphasis on the importance of establishing a Quality Management System (QMS) in compliance with MDR requirements. Unlike Revision 0, which mentioned the quality management requirements more generally, the new revision specifies that manufacturers of legacy devices must have an operational QMS that complies with Article 10(9) of the MDR since May 26, 2024. This includes post-market surveillance and risk management.



6. Post-Market Surveillance and Risk Management

The requirements for post-market surveillance and risk management were already present in Revision 0, but Revision 1 expands and strengthens their application for legacy devices. The new version highlights the importance of Periodic Safety Update Reports (PSURs) and stresses the need to collaborate with notified bodies to ensure ongoing device monitoring.



In summary, Revision 1 introduces important adjustments, providing manufacturers of legacy devices with more time to comply with the MDR while clarifying key points. Compared to Revision 0, this new version provides more precise answers to manufacturers’ questions and strengthens certain obligations, particularly regarding quality management and post-market surveillance.




5. Implications for Manufacturers


Revision 1 of the MDCG 2021-25 guide has direct and significant implications for manufacturers of legacy devices who wish to continue marketing their devices in the European market while gradually complying with Regulation (EU) 2017/745 (MDR). The changes introduced by this revision extend certain deadlines and provide useful clarifications, but they also impose specific actions that manufacturers must take to ensure compliance. Here are the key impacts for manufacturers:



1. Extended Deadlines:

More Time, but No Complacency One of the main implications of this revision is the extension of transition deadlines until 2027 or 2028 for certain devices depending on their classification. While this gives manufacturers additional time to comply with the MDR’s strict requirements, it is crucial for them to use this time proactively. Manufacturers must start preparing now by implementing the necessary procedures and working with notified bodies to ensure their devices are compliant by the deadlines.


Manufacturers who fail to anticipate these requirements risk delays in certification and, consequently, disruptions in the marketing of their products.



2. Implementation of the Quality Management System (QMS)

A critical point in Revision 1 is the obligation for all manufacturers of legacy devices to have implemented a QMS compliant with the MDR by May 26, 2024. The QMS must cover key aspects such as post-market surveillance, risk management, and product traceability.


Manufacturers must not only have an operational QMS, but it must also be audited and validated by a notified body as part of MDR compliance. This may require reviewing and, if necessary, improving internal management processes to meet the new requirements.


By the way, CSDmed is an ICA 13485 auditor… We can help you with this… Contact us now!



3. Strengthened Post-Market Surveillance

One of the fundamental principles of the MDR is the implementation of a robust post-market surveillance (PMS) system. All manufacturers of legacy devices are required to actively monitor the performance and any incidents related to their devices once they are marketed. They must prepare PSURs and make them available to competent authorities and notified bodies during audits.


Companies should review their data collection and analysis processes regarding the safety and performance of their devices to meet the strengthened post-market surveillance requirements. This surveillance is essential not only to comply with regulations but also to ensure patient safety and minimize risks to the end users.



4. Collaboration with Notified Bodies

Manufacturers of legacy devices must work closely with notified bodies, which are responsible for overseeing the continued compliance of devices during the transition period. It is essential to have submitted a formal request for a conformity assessment to a notified body before the relevant deadlines and to have signed a surveillance agreement by September 26, 2024.


This collaboration is crucial to ensure that legacy devices meet MDR monitoring requirements and can continue to be marketed until the end of the transition period. Failure to meet these deadlines or obligations could result in supply chain disruptions or the removal of devices from the market.



5. Management of Systems and Procedure Packs

Manufacturers who market systems and procedure packs containing legacy devices must ensure compliance with the new clarifications provided in Revision 1. The regulation allows systems or packs composed solely of legacy devices to be sold during the transition period. However, systems combining MDR-compliant and legacy devices must ensure that each component complies with the specific rules applicable to it.


Managing these combined systems will require a thorough review of technical documentation, compliance processes, and risk management strategies.


Manufacturers must ensure compliance with the new MDR requirements and use the extended transition period to prepare for audits and assessments by notified bodies. The implementation of a strong QMS, strengthened post-market surveillance, and close collaboration with notified bodies will be key factors in ensuring the continued marketing of legacy devices until the deadlines of 2027 and 2028.




6. Practical Tips for Ensuring Compliance


In light of the strengthened requirements introduced by Revision 1 of the MDCG 2021-25 guide and the extended transition deadlines, manufacturers of legacy devices must take proactive steps to ensure their devices are compliant with Regulation (EU) 2017/745 (MDR). Here are some practical tips to guide manufacturers through this compliance process:



1. Anticipate and Plan Your Compliance Steps

Although deadlines have been extended until 2027/2028 for some devices, it is crucial not to wait until the last minute to ensure compliance. Manufacturers should:

  • Assess the status of their legacy devices and determine the actions required for each device class.
  • Create a detailed roadmap of the steps needed to comply with the MDR before the deadlines.
  • Allocate the necessary resources (human, technical, and financial) to implement the new requirements smoothly and efficiently.


2. A Quality Management System (QMS) in Place

An essential element of MDR compliance is the implementation of a QMS compliant with Article 10(9) of the MDR by May 2024. To ensure effective implementation:

  • Audit your existing QMS with CSDmed to identify gaps with MDR requirements.
  • Strengthen documentation on critical processes such as post-market surveillance, risk management, and traceability.
  • Engage internal teams to ensure that all departments (R&D, production, quality, regulatory affairs) actively participate in compliance efforts.
  • Establish regular internal audits to ensure that the QMS remains compliant throughout the lifecycle of the devices.


3. Strengthening Post-Market Surveillance (PMS)

Post-market surveillance (PMS) is a key requirement of the MDR, particularly for legacy devices. Manufacturers must:

  • Develop and update a PMS plan covering the collection and analysis of data on device performance after they are placed on the market.
  • Establish a process to produce PSURs, especially for Class IIa, IIb, and III devices. These reports must be made available to competent authorities and notified bodies during audits.
  • Actively monitor incidents and take corrective actions where necessary, ensuring rigorous follow-up of defective or risky devices.


4. Collaborate with Notified Bodies

Notified bodies play a central role in assessing the compliance of legacy devices during the transition period. It is crucial to:

  • Have contacted a notified body and submitted a formal request for a conformity assessment. If not, contact us now, and we will find solutions.
  • Carefully prepare the technical documentation required for each device, including design dossiers and clinical reports.
  • Sign an agreement with the notified body by September 26, 2024, to ensure ongoing surveillance of your devices. If this hasn’t been done, contact us now, and we will find solutions.

A solid and proactive relationship with the notified body will facilitate the transition to MDR compliance and minimize the risk of delays or non-compliance.



5. Follow Clarifications for Systems and Procedure Packs

If you manufacture or market systems and procedure packs containing legacy devices, it is essential to:

  • Identify the components of the packs that qualify as legacy devices and those compliant with the MDR.
  • Ensure the traceability of devices within these systems to meet MDR transitional requirements.
  • Update technical documentation to ensure that systems and packs comply with the rules applicable during the transition period.


6. Train and Educate Teams

Internal teams play a key role in achieving compliance. Ensure that your teams:

  • Receive regular training on MDR requirements, especially the new obligations introduced by Revision 1.
  • Understand the procedures to document, report, and respond to incidents related to the devices.
  • Are involved in the process of updating the QMS, so that all departments are aligned with the new regulations.


7. Stay Informed of Regulatory Developments

Medical device regulations are constantly evolving. It is essential to:

  • Closely follow updates from the MDCG and changes in the European regulatory framework.
  • Participate in webinars, conferences, and workshops on MDR compliance to stay informed of best practices.
  • Collaborate with specialized MDR compliance consultants like CSDmed to ensure that your devices meet all applicable requirements. Contact us to find the best support for your needs.

To learn more about how to compile a technical file in accordance with MDR Annexes II and III, check out our article: Annexes II and III of the MDR: How to Create a Technical File to Obtain CE Marking for Your Medical Devices.


Compliance with MDR requirements for legacy devices requires a proactive and structured approach. By carefully planning the actions to be taken, collaborating closely with notified bodies, and ensuring continuous device monitoring, manufacturers can guarantee the compliance of their products and their continued availability on the European market. Meeting the deadlines and implementing a robust Quality Management System (QMS) will be key to successfully managing this transition.




Conclusion


Revision 1 of the MDCG 2021-25 guide marks a crucial step for manufacturers of legacy devices in their transition towards compliance with Regulation (EU) 2017/745 (MDR). Thanks to the extended transition deadlines until 2027 or 2028, manufacturers now have additional time to adapt to the new requirements, including the implementation of a Quality Management System (QMS), post-market surveillance, and collaboration with notified bodies.


However, this extended deadline should not be seen as an opportunity to procrastinate. It is imperative to begin implementing the necessary changes now to ensure timely compliance. Rigorous planning, proactive action, and close collaboration with notified bodies will be key factors in ensuring the continuity of operations and the safety of medical devices on the European market.


The ultimate goal of these revisions is to enhance patient safety while enabling medical device companies to navigate this evolving regulatory landscape efficiently. Success lies in smooth compliance and constant vigilance regarding post-market surveillance requirements.




💡 Need help complying with the new MDR requirements?


Our team of specialists is here to assist you at every step of your transition to MDR compliance. Whether you need an audit of your Quality Management System (QMS), help with managing your Periodic Safety Update Reports (PSURs), or advice on collaborating with a notified body, we are available to help you secure your compliance before critical deadlines.


👉 Contact us today to schedule a personalized consultation and ensure your legacy devices remain on the European market while guaranteeing patient safety and regulatory compliance.


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