The Extended Medical Devices Regulation Transition

On February 16th, the European Parliament approved a significant extension to the Medical Devices Regulation (MDR) transition period. This unsurprising extension pushed the end of the period from May 2024 to December 2027 for higher-risk devices. The new EU MDR deadline for lower-risk devices will be extended further, to December of 2028.

Why the extension was unsurprising

This development didn’t come as a surprise. In an update issued in December 2022, the European Council acknowledged that the implementation of MDR is significantly behind schedule. By October 2022, manufacturers had submitted 8,120 applications for MDR certification, yet only 1,990 certificates had been issued. Meanwhile, of the 22,793 “legacy” certificates issued under MDD and AIMDD, 1,387 had expired by the end of 2022. In 2023, over 4,000 more will lapse. This number will increase to 17,000 during the first half of 2024.

These sobering figures have not gone unnoticed. The European Commission has been signaling for months that it was considering modifications to the MDR timeline. Meanwhile, the Medical Device Coordination Group (MDCG) has proposed measures designed to forestall any interruptions to the future supply of devices. These include granting temporary exemptions under Article 97 of the Regulation, which could help to avert what many see as an impending crisis.

For their part, industry bodies — and many independent commentators — have delivered stark appraisals of the MDR’s faltering implementation. They’ve warned that, in the absence of concessions by the Commission, a wide range of devices could be withdrawn from sale in European markets. The impact on patients across the region could be profound.

Complicating factors for an EU MDR transition extension

There is a clear consensus on some of these points. Of course, no one wants vulnerable patients to suffer. All the key players acknowledge that this doomsday scenario is a real threat, and that decisive steps must be taken to prevent it. The MDCG’s position paper on Article 97 exemptions stresses the importance of limiting “the impact on the supply of safe and effective devices to patients and healthcare providers.”

The position of the MDCG reflects its unique role as both a key advisor and a representative body for the national agencies charged with implementing the MDR. As such, it is demonstrating flexibility while drawing some clear lines. The proposed exemptions under Article 97 are a case in point, since they will be subject to strict conditions. To benefit from them, manufacturers must first show that they’ve made meaningful efforts to achieve compliance under MDR. If granted, the exemptions will also be accompanied by deadlines for completing that process.

In other words, regulators recognize the scale of the problem and are ready to act. However, they aren’t prepared to take any steps that will dilute the original intentions of the Regulation. There will be no compromises on patient safety or clinical data quality. Additionally, there will be no exceptions or “grandfather” clauses for older products. Manufacturers have been granted a reprieve, not given a free pass.

Implications for the Road Ahead

So, how will this extension impact manufacturers and their service partners? How will this process unfold over the next four years? In its explanatory memorandum on the amendment, the Commission seeks to chart a course forward.

First, the Commission acknowledges what device makers have been pointing out for some time – that the capacity of notified bodies has so far fallen short of what’s needed to keep up with demand. It says the number of notified bodies will increase, with 26 applications now being processed. If this additional capacity comes on stream as planned, up to 7,000 new certificates could be issued by May 2024. The Commission has also confirmed that there will be no enforced “sell-off” of devices still in the supply chain when their certifications expire. This clarification eliminates another industry-wide point of contention.

In the view of the Commission, however, the industry must also play a part in accelerating progress. It says device makers must begin by clarifying which devices they intend to discontinue. One reason is obvious: staggered timelines based on device classes can’t function if the industry’s pipelines remain opaque.

Additionally, the Commission likely has more pragmatic considerations in mind. Like everything else the EU does, the MDR must respect the principle of subsidiarity. The Union can only act in areas where member states cannot do so by themselves. Crucially, the functioning of notified bodies may only be supervised by member states in which they’re based. Member states may be more inclined to intervene if faced with the prospect of specific devices disappearing from their healthcare systems.

Whatever its thinking, the core of the Commission’s message remains simple: MDR isn’t going away. The amended timeline isn’t a compromise; but the basis for a more orderly transition. To benefit from this extension, manufacturers and their partners must act now.