European Parliament’s approval of MDR delay brings relief but questions remain

| by Deirdre Harrington

The European Parliament’s approval of the proposal to delay the Medical Device Regulation transition period brings some reassurance to the industry. In February 2023, the Parliament voted by an overwhelming majority to adopt the European Commission’s proposal to delay the transition.

The delay extends the deadline for higher risk class III and class IIb devices to 2027 and to 2028 for lower risk class I and class IIa devices.

A European Union survey in late 2022 found 23,000 devices would need to be re-certified or withdrawn. And, until the approval to delay the transition period, as many as 17,000 certificates under the Medical Devices Directive were due to expire in 2024. Not surprisingly, this raised huge concerns about loss of products on the EU market.

The delay is good news, but questions remain

Nevertheless, much still remains unclear. Will the extensions apply to all manufacturers? If those products are still in the queue for notified body review by the end of the extension, will they automatically come off the market? If no contract has been signed with a notified body as yet, what does that mean for the product? There is not a lot of information around what the delay actually means for each individual device manufacturer and how it impacts their current situation.

The industry will be eagerly awaiting the European Commission’s guidelines, but for now, companies and notified bodies alike are breathing a huge sigh of relief.

Problems were anticipated

The notified bodies have long been flagging their concerns over conformity assessments and the fact that certificates were likely to expire before products could be assessed.

However, the commission had been optimistic that a lot of companies would start early and that more devices would have gone through the MDR by this stage. They did not anticipate all the issues with the notified bodies, such as resourcing challenges, or consider the fact that the notified bodies would have double the workload as they continued to support products under the directive while handling MDR assessments.

As a result, there was a lack of planning, forcing the commission to scramble to prevent massive numbers of products from going off the market. That would have left patients and healthcare providers with a limited pool of devices until the backlog of assessments could be performed.

Notified bodies are largely optimistic that the delay will prevent the massive loss of devices that might have occurred.

While the delay is good news, it’s important that device manufacturers don’t take their foot off the pedal when it comes to striving to comply with the MDR, or in 3 or 4 years we will be facing the same product shortage that potentially might have occurred in the next couple of years. After all, the European Parliament’s vote is simply to delay the transition period. MDR is not going away.

“The notified bodies have been long flagging their concerns over conformity assessments and the fact that certificates were likely to expire before products could be assessed.”

Reference:  Notified Bodies Survey on certifications and application (MDR/IVDR) MDCG & Stakeholders, 24 Oct 2022