top of page
  • pharmaserviceinc

Formal proposal to delay IVDR

Updated: Nov 4, 2021

We now have a formal proposal from the European Commission to delay #IVDR.

The proposal does not change any requirements of the Regulation but only changes the transitional provisions to allow the Regulation's progressive rollout. The length of the proposed transition periods depends on the type of device: higher risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), have a transition period until May 2025 and 2026, whilst lower risk ones such as class B and A sterile devices, have a transition period until May 2027.

Check the information here:

If you are a manufacturer which needs help with the EU Market, do not hesitate in contacting us for being your Authorized Representative in the European market. We work with medical devices, cosmetics and nutraceuticals products. Also, if you need Regulatory advice, documents review, or importation services, do not hesitate in contact us! We will match any quotation you bring us and give you 100% off the competitor´s rate.

3 views0 comments


bottom of page