Industry news -

Medical Device Regulation: EU extends transition period

The transitional period for the re-certification of existing products will not expire in 2024 as planned, but only in 2027 and 2028

Image source: Guillaume Périgois on Unsplash

In the last few years, we have repeatedly reported on the EU Medical Devices Regulation. This included recommendations for action in preparation and how regulatory affairs positions can be filled.

Now, both the European Parliament and the European Council have adopted the EU Commission's proposal to extend the transition period for the recertification of existing products. Previously, the deadline was 26 May 2024. Products with a higher risk do not have to be recertified until the end of 2027 and products with a medium to low risk until the end of 2028.

Which medical devices are affected?

The extension is subject to certain conditions and applies, for example, to:

  • surgical instruments
  • medical software
  • Endoscopes
  • Devices for intensive care medicine
  • Baby stents
  • Radiofrequency perforation catheter

Why an extension?

Since the regulation was adopted, SMEs in particular have seen a major challenge in its implementation. The additional bureaucratic hurdles and the lack of regulatory affairs staff have been cited as the biggest point of criticism. Now, additionally, hospitals have warned of possible bottlenecks as there are not enough places for the certification of medical devices.

The extended transition period is intended to ease the bottleneck situation.

Our expertise for you

If you are still looking for the right Regulatory Affairs Specialist or Manager for your company, then we can support you with our specialised network. The recruitment consultants at BESTMINDS have been staffing highly qualified specialists and executives in the medical technology, diagnostics and pharmaceutical industries with a great deal of expertise and commitment for over 10 years. Fairly, loyally and discreetly, we meet your challenges and wishes. Please feel free to contact us for a non-binding initial interview to fill your new employee (m/f/d) on time.

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