Industry news -

Effects of the new regulation of medical devices (MDR) and in vitro diagnostics (IVDR)

The EU regulation will result in a stricter MedTech regulation in Europe.

The new, very comprehensive EU medical device regulation, Medicine Device Regulation, MDR, replaces the previous medical device directives.
Likewise, the 477-page new regulation IVDR - In Vitro Diagnostic Device Regulation, replaces the previous IVD directive (98/79/EC).
These include significant updates to the regulations for clinical evaluation reports for the entire in vitro diagnostics market and the detailed and comprehensive evaluation of medtech products in the EU. This affects the areas of development, market surveillance and application.

The "Neue Züricher Zeitung" recently commented aptly on this in its article "When politics gives birth to a monster": "... especially the SMEs will suffer..."

The stricter requirements of the IVDR for in vitro diagnostics and MDR for medical devices, which were developed with the intention of patient safety, would primarily be at the expense of the entire industry and the consumers of medical devices.

The three-year and five-year transition periods are passing quickly. Act now!

Recommended action to prepare for the IVDR*:

  1. Bring your QM system up to date (ISO 13485:2016)
  2. Form a working group of development, logistics and production to define your UDI strategy.
  3. Find out in which class your products fall.
  4. Create a gap analysis for the technical documentation and the post-market system.
  5. Close the Gaps.
  6. Agree the timetable with your notified authority.

Good specialists and managers are indispensable in order to master the changeover phase in a predictable and best possible way.

BESTMINDS GmbH will be happy to support you. Please contact us.
We are more specialised. We are more competent. We are much closer.




*(Prof. Dr. Christian Johner: "IVDR – In-vitro-Diagnostic Device Regulation" ,16.03.17)

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