EU Medical Devices Legislation: What You Need To Know Given Latest Developments and Ongoing Challenges

We are sure that you are aware that the European Union (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 Advisory 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(MDD), the Active Implantable Medical Devices Directive (AIMDD), and the In Vitro Diagnostic Directive (IVDD) — has been replaced by the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR).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. The validity of certificates 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 can 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. 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. While the conditions and criteria that must be fulfilled for extensions to apply are similar across the MDR and IVDR, the dates of extensions differ: for medical devices, the deadline for such extensions is until December 31, 2027 or December 31, 2028 depending on the risk class; and for IVDs, until December 31, 2027, December 31, 2028, or December 31, 2029 depending on the 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.

The Annex to this Advisory 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 medium sized 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.

Anyone interested in giving feedback to the European Commission must do so by March 21, 2025 using this online portal. Several topics are discussed, and we anticipate that companies will need to allow a good amount of time to respond to all of the questions. You can also see feedback from other stakeholders on the consultation site.

It is essential that medical device manufacturers provide their input, as they are the ones who are most affected and who are required to apply the long list of MDR and IVDR requirements in order to market their devices. It is equally important that companies from the pharmaceutical sector, who are dependent on medical devices or IVDs for the administration and use of their medicinal products, as well as for testing (in both a pre-clinical and post-authorization context), take the time to participate in this survey.

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 U.S. Food and Drug Administration to take on a coordinating role and ensure the consistent application of the devices and IVDs regulatory framework. The European Medicines Agency (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.

There are also a number of pilot projects that 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.

If you would like to speak about the current changes and how they may impact your product portfolio in the EU — or indeed the UK — please feel free to get in touch. You can also follow developments on our BioSlice Blog.

Annex

Transition Period Under the MDR

For medical devices covered by a certificate issued by a notified body under the MDD/AIMDD valid on May 26, 2021, and not withdrawn thereafter, the certificate shall continue to remain valid until the following dates, provided certain conditions are met:

• December 31, 2027: Class III and Class IIb implantable (with exceptions)
• December 31, 2028: Class IIb (with exceptions), Class IIa, and Class I sterile or measuring

Certificates that expired prior to March 20, 2023 shall be considered valid until the above dates, provided one of the following conditions have been met:

• Before the date of expiry on the certificate, the manufacturer and a notified body have signed a written agreement in accordance with the MDR for the conformity assessment in respect of the medical device covered by the expired certificate or in respect of a medical device intended to substitute that device.
• Alternatively, if no such contract was signed prior to expiry, a national competent authority may have granted a derogation from the applicable conformity assessment procedure, or has required the manufacturer to carry out an assessment to bring a non-compliance, which does not present an unacceptable risk to health or safety of patients, to an end within a specified period.

For medical devices which were low risk under the MDD/AIMDD, but require notified body involvement under the MDR, and for which the declaration of conformity was drawn up under the MDD/AIMDD prior to May 26, 2021, the transition period ends on December 31, 2028, provided conditions are met.

The European Commission has published a Q&A on practical aspects related to the MDR extended transition period

Transition Period Under the IVDR

For IVDs covered by a certificate issued by a notified body under the IVDD valid on May 26, 2022, and not withdrawn thereafter, the certificate shall continue to remain valid until December 31, 2027, provided conditions are met.

Certificates that expired prior to July 9, 2024, shall be considered valid until the above date, provided one of the following conditions have been met:

• Before the date of expiry on the certificate, the manufacturer signed a contract with a notified body for the conformity assessment of the IVD in question under the IVDR.
• Alternatively, if no such contract was signed prior to expiry, a national competent authority may have granted a derogation from the applicable conformity assessment procedure, or have required the manufacturer to carry out the conformity assessment procedure within a specific time period.

For IVDs, which were low risk under the IVDD but require notified body involvement under the IVDR and for which a declaration of conformity was drawn up under the IVDD prior to May 26, 2022, the transition period has been extended, provided conditions are met, as follows:

• December 31, 2027 for Class D high individual and public health risk IVDs (e.g., HIV or hepatitis tests)
• December 31, 2028 for Class C high individual and/or moderate public health risk IVDs (e.g., cancer tests)
• December 31, 2029 for Class B and Class A sterile lower risk IVDs (e.g., sterile IVDs such as blood collection tubes)

The European Commission has published a Q&A on practical aspects related to the extended transition period provided for in the IVDR.

Conditions

In addition, for all transition periods to apply, certain conditions must be met for both medical devices and IVDs, as follows:

• Continue to comply with the MDD, AIMDD, or IVDD
• Have not been subject to significant changes in the design or intended purpose
• Do not present an unacceptable risk to the health or safety of users, or to public health
• The manufacturer put in place an MDR/IVDR compliant quality management system by no later than May 26, 2024 for medical devices and May 26, 2025 for IVDs
• The manufacturer made a formal application for conformity assessment to a notified body:
  • By May 26, 2024 for medical devices (or a medical device intended to substitute that device); and the notified body and manufacturer signed an agreement in accordance with MDR by September 26, 2024
  • By May 26, 2025 (class D), May 26, 2026 (class C), or May 26, 2027 (class B and A sterile IVDs) for the conformity assessment of the “legacy device” covered by an IVDD certificate or declaration of conformity, or in respect of IVDs intended to substitute that device under the IVDR. Within four months thereafter of each respective date, the application must be covered by a written agreement between the manufacturer and the notified body.

The “sell-off” deadline has also been removed. As such, medical devices and IVDs already placed on the EU and the European Economic Area market under the old EU rules can remain in the supply chain, and be made available to end users, without having to be taken off the market.

© Arnold & Porter Kaye Scholer LLP 2025 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.