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).
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.
To ensure you prepare for the new requirements in the most effective manner, see below for all information published by us at a glance.
- Blog post published on 5 July: New requirements based on the IVDR: An interview with Vice President Dr Andreas Stange
- FAQs: In Vitro Diagnostic Medical Device Regulation (IVDR)
- Overview on key changes, timeline and how you can prepare on our TÜV SÜD webpage
- Brochure „EU’s In VitroDiagnostic MedicalDevice Regulation“
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