We are sure you are aware that the EU medical devices framework has been subject to significant changes over recent years. However, implementation of the new rules has been problematic since the beginning, as both the industry and the EU institutions, national authorities, and notified bodies have found it difficult to adapt to the stricter and demanding new legal requirements. There are ongoing delays in companies obtaining CE marks under the new regime, criticism that the rules are stifling innovation, and concerns about the impact on patients.
Given the calls for change, criticism, and ongoing consultations, this article sets out the current status of developments and what is important to know when seeking to do business in the EU.
What You Need To Know
- The previous regulatory regime — the Medical Devices Directive (MDD), the Active Implantable Medical Devices Directive (AIMDD), and the In Vitro Diagnostic Directive (IVDD) — has been replaced by the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR).
- Devices on the EU market under the old rules can remain on the market under the transition periods. Certificate validities have been extended and depend on various criteria and conditions being met. For medical devices, the deadline for such extensions is until December 31, 2027 or December 31, 2028 depending on the risk class. For IVDs, the deadline is until December 31, 2027, December 31, 2028, or December 31, 2029, again depending on the risk class.
- There continues to be criticism and calls for change. The European Parliament called on the European Commission to amend the legislation and processes, and the European Commission is currently conducting a consultation with the aim of presenting a package of changes later this year. Feedback could be provided by anyone in the industry by March 21, 2025.
- The EU institutions are continuing with implementation of the MDR and IVDR, with a number of pilot schemes and a particular focus on expert groups to provide harmonized guidance. However, questions still remain about how the framework should operate and companies are facing inconsistent decisions about their products.
Extension Of Transition Provisions
The MDR and IVDR require all medical devices and in vitro diagnostics (IVDs), including those that have been on the EU market for many years, to undergo a conformity assessment procedure under the new regime. However, transition periods are in place, during which time devices that are authorized under the MDD/AIMDD and IVDD can continue to be placed on the EU market.
Due to delays, complexities, and capacity issues, the transition periods under both the MDR and the IVDR have been extended, as noted in the previous section. Under both regulations, the length of the extension is dependent on the risk class of the device, with the period being shorter for devices falling into a higher risk class.
For all transition periods to apply, certain conditions must be met, including that the device/IVD has not been subject to significant changes in design or intended purpose and that certain provisions of the MDR/IVDR are already complied with (such as requirements in relation to post-market surveillance, market surveillance, and vigilance).
Further, by now, the manufacturer should have entered into an agreement with a notified body for conformity assessment of the device under the MDR (with later dates applying to IVDs under the IVDR). If this is not in place, the transition periods do not apply.
This Annex to our original publication provides an overview of the relevant timelines and conditions that must be met.
European Parliament Resolution On The Urgent Need To Revise The MDR And IVDR
In addition to the extension of the transition periods, other problems regarding, for example, capacity of notified bodies, the slow progress in building EUDAMED (a vital database necessary to comply with certain MDR/IVDR requirements), and risks for shortages have been recognized as putting increased pressure on the market.
As such, the European Parliament adopted, on October 23, 2024, a Resolution on the urgent need to revise the MDR and IVDR. Parliament resolutions do not have a binding legal effect, but their purpose is to express the European Parliament's opinion and is a call for action for other EU institutions or Member States.
The European Parliament has suggested that the European Commission consider the following key actions:
- Propose by the end of Q1 2025 legislative amendments to the MDR/IVDR.
- Harmonize provisions and ensure consistency across the EU.
- Introduce rules for orphan and pediatric medical devices.
- Consider fast-track and prioritization pathways for the approval of innovative technologies in areas of unmet medical need.
- Develop specific measures to support small and midsize enterprises (SMEs).
Furthermore, the European Parliament has commented on the need to improve notified body operations, including the need to increase transparency in fees, increase capacity "to meet market demand," and create transparent and binding timelines for conformity assessment. Currently, notified bodies are not bound by any legal provision to conduct conformity assessments within a specific timeframe, and the current average time is around 18 months.
Commission Consultation
The European Commission has not yet taken action in response to the European Parliament's Resolution. However, in December 2024, the European Commission launched a consultation to address the issues repeatedly emphasized by the industry. The aim is to understand what went wrong with the implementation of the two regulations. However, it has been questioned whether this consultation is necessary given the extent of the existing debate and volume of information already available about the problems with both regulations.
Continued Implementation Of The MDR And IVDR
Despite the criticism and ongoing consultations, the EU institutions have continued to implement the MDR and IVDR. For example, the MDR and IVDR empower the European Commission to establish expert panels and designate them for certain areas where the European Commission identifies a need for consistent scientific, technical, and/or clinical advice. It is intended that by having a centralized expert panel opine on the requirements under the MDR and IVDR, this will lead to greater consistency in application of the regulations.
The EU lacks a centralized medical devices agency equivalent to the FDA to take on a coordinating role and ensure the consistent application of the regulatory framework to devices and IVDs. The EMA has been given a coordinating role in the operation of device expert groups, but it is not yet clear whether the EMA has the capacity or expertise to help resolve some the issues identified.
A number of pilot projects also have been announced, including measures to facilitate the development of medical devices for rare conditions published in the Medical Devices Coordination Guidance on the clinical evaluation of orphan devices and a new pilot scheme for coordinated assessment of clinical investigations of medical devices and performance studies for IVDs announced in February.
The proliferation of expert panels and pilot programs, and the expanded role of the EMA, give an indication of the direction of travel that the European Commission may take in any revision of the regulations. However, it is not yet clear if the changes will be sufficient to address the various concerns raised.
Top Tips For Companies
The implementation of the MDR and IVDR is progressing, but it is recognized that the identified challenges pose significant threats to the proper functioning of the regulatory framework, which is having an impact on the availability of medical devices and IVDs in the EU. The next couple of years will likely bring more revisions and adaptations to the current regulatory framework. In the meantime, companies should:
- Be clear about which rules apply to your device and when.
- Make sure you have a clear understanding of the transition provisions and the conditions attached, and can demonstrate these are met for your products.
- Monitor developments and actions taken by the EU institutions.
- Engage with consultations and pilot schemes to help shape the future legislation.
- Establish a good relationship with your notified body and ensure you seek clarity on assessment timelines.
- Enter into dialogue with your notified body if you see inconsistent or unclear decisions; remember that notified bodies are working within the same inconsistent framework that you are.
Originally published by Med Device Online.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
