In response to mounting pressure from stakeholders throughout the sector, the European Commission has proposed a set of extended transition timelines under the MDR. Our Products team takes a look at this important development in the EU market and what it means for manufacturers of hardware and software medical devices.

Although the Medical Devices Regulation (EU) 2017/745 (the MDR) has been in force since 26 May 2021, transitional provisions allow certain medical devices that are compliant with the Medical Device Directive 93/42/EEC (the MDD) to remain on the EU market until 26 May 2024. In order to remain on the market after that date, any devices currently availing of these transitional provisions must be MDR compliant. This is particularly important for developers of medical device software who must now arrange for conformity assessment of their devices by a notified body in order to secure certification under the MDR. With a surge in demand and a limit on notified body capacity, calls for an extension to the existing transition timelines in order to avoid the removal of devices from the EU market have been steadily growing. In response to mounting pressure, the EU Commission has now proposed a set of extensions to this transition period. We take a look at the background to this development and the consequences for business.

Background

In the run up to 26 May 2021, significant concern was already being expressed around the low number of notified bodies applying for designation under enhanced MDR requirements. Meanwhile, Rule 11 of the device classification rules provided for in Annex VIII of the MDR, which are addressed to software devices specifically, provide that a high number of software devices that would previously have been class I devices under the MDD are now class IIa devices (at least) under the MDR. The practical consequence of this is that in order to remain on the EU market, manufacturers of these devices must arrange for conformity assessment by a notified body for the first time. This has resulted in a ‘bottleneck’ effect resulting in significant delays for manufacturers seeking to demonstrate MDR compliance before the end of the transitional period.

On 14 June 2022, the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) met to discuss this feature of the implementation of the MDR. EPSCO recognised the “severe challenges” posed by the shortage of notified bodies and noted that it could “threaten the continued availability of certain medical devices” on the EU market. On 17 November 2022, the Medical Devices Coordination Group (MDCG) held an extraordinary meeting to discuss solutions. At the meeting, a large number of Member States’ representatives spoke in favour of an extension to the current timelines.

Concerns persisted however, and EPSCO met again on 9 December 2022. In her opening remarks, EU Commissioner for Health and Food Safety, Stella Kyriakides, noted that:

“Patient safety is always paramount. The transition… has been slower than we anticipated. The pandemic, shortages of raw materials caused by the Russian war against Ukraine and low notified body capacity has put a strain on market readiness… Devices covered by around 23,000 certificates issued under the previous directives have not yet transitioned to [the MDR] and will expire by 26 May 2024 at the latest… We are facing a risk of life saving medical devices for patients. This is a risk we cannot take. I therefore propose to you today that we extend the transition period of the [MDR] to mitigate any short-term risk.”

Proposed solutions

As a result, a number of measures were proposed at the EPSCO meeting which now form the basis of a proposal since adopted by the European Commission:

• A new transition deadline for higher risk class IIb implantable devices (with some exceptions) and class III devices of 31 December 2027
• A new transition deadline for lower risk class I and class IIa devices (and class IIb devices not covered by the longer extension in respect of higher risk devices) of 31 December 2028
• A new transition period for class III implantable custom-made devices with a deadline of 26 May 2026, and
• A removal of ‘the sell-off date’ of 26 May 2025 to prevent safe medical devices already on the market from being discarded

These proposals have been greeted with relief by most manufacturers who have been as yet unable to access conformity assessment services. However, the requirement to recertify devices under the MDR has not changed and access to these extended timelines would be subject to several cumulative criteria including the following:

• In line with existing requirements provided for under Article 120 of the MDR, the devices in question must not undergo any ‘significant changes’ in design or intended purpose. This is particularly important for software devices that would ordinarily be updated and upgraded regularly to keep pace with market trends and added features of competitor devices, and
• Manufacturers will be required to demonstrate that they have already undertaken the necessary steps to launch the certification process, for example by bringing their quality management system into compliance with the MDR and submitting an application for conformity assessment to a notified body by 26 May 2024

Next steps

The proposal adopted by the European Commission now needs to be adopted by the European Parliament and the Council using an accelerated co-decision procedure.

In line with comments from Commissioner Kyriakides that a proposed amendment should be accompanied by measures aimed at addressing the “structural problems” of the MDR, the European Commission has also committed to undertake a comprehensive evaluation of the MDR by May 2027 and has suggested it will propose further amendments where appropriate to protect “patient safety, public health or medical innovation”.

In light of these developments, medical device manufacturers should:

• Carefully consider the text of the proposed amendment of the MDR
• Remain in close contact with their current or planned notified body regarding practical implications for application processes and project planning
• Maintain momentum on application preparation and submission projects given the need to demonstrate that steps have been taken to launch the certification process

For more information, please contact a member of Product Regulatory and Liability team.

The content of this article is provided for information purposes only and does not constitute legal or other advice.