E-ssentials MedDev Blog

Regulatory updates for the medical device industry

In force – the IVDR! Take action now!

In three and a half years, from May 2022, in-vitro diagnostics (IVD) will face the obligation to correspond to Regulation (EU) No. 2017/746 (IVDR).

IVDR timeline

The final text of the IVDR was published as a proposal on 22 February 2017 and adopted by the European Council on 7 March 2017. The regulation was then published on 5 May 2017 and came into effect on 26 May 2017.

Dr Andreas Stange, Vice President Medical Health Services IVD global, has a short message for you:

Key changes of the IVDR

Here is a summary of all key changes at a glance.
Please bear in mind that the IVDR does not include a grandfathering clause. In other words, already approved IVDs must also be certified according to the new requirements. Manufacturers are granted a five-year period to do so.

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Dr. Andreas Stange

Dr. Andreas Stange

Vice President Medical Health Services IVD global

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