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