The Latest Version of the Manual on Borderline and Classification under MDR and IVDR is Here!
The latest updates in the world of medical device regulations in Europe.
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The certification process and increased costs slow the growth of the medical devices market
Science and technology grow rapidly, and so does the supply of medical devices. It is estimated that there are more than 500 000 types of medical devices and in vitro diagnostic medical devices on the EU market.
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Webinar: Regulation 2023/607 MDD Extension and its Impact on Manufacturers
Regulation 2023/607 was published in March 2023, extending MDD validity by up to 5 years. Join a free of charge webinar to learn about the impact on conformity assessment and marketing authorization of this regulation.
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A new online MDR Postgraduate Course
A new online MDR Postgraduate Course will be organised starting with September 25, 2023 within NoBoCap project.
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Notified Bodies Survey on certifications and applications (MDR/IVDR)
We are delighted to announce some significant developments from the European Commission.
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Start-ups left hanging in EU medical device regulation snarl-up
Delays in getting the CE mark for medical devices are stretching the resources of European start-ups and forcing some to turn their attention to the US Europe is facing a…
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