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2022-01-25 Regulation 2022_112 amending IVDR - transitional provisions

IVDR : Amendment on transitional measures published on January 28, 2022.

A summary by MediMark Europe

The Amendment* to the Regulation (EU) 2017/746 on transitional measures was proposed by the European Commission in October 2021.This proposal was voted as is by the European Parliament on 15/12/2021, then by theCouncil of the European Union on 20/12/2021, adopted as EU Regulation on 25/01/2022 and published on 28/01/2022 in the Official Journal of the European Union. This amendment applies to all Member States from the date of its publication.

1) Content of the amendment

-  The IVDR application date remains unchanged: May 26, 2022
-  This amendment extends the transition period to all products with a declaration of conformity in accordance with the Directive established before May 26, 2022, and requiring, according to the IVDR, the intervention of a notified body.
-  It extends the transition period initially planned for all products covered by a certificate according to the Directive (Annex II, self-tests)
-  It extends the transition period of certain provisions for devices manufactured and used exclusively by healthcare establishments (“in-house assays”)

2) Conditions for the application of this amendment

For products covered by an IVDD certificate established before May 26, 2022 and until the end of the certificate’s validity:
-  Compliance with the Directive is maintained
-  No significant change in product design or destination
-  Application of the requirements of the IVDR Regulation in terms of post-market surveillance, vigilance and registration of economic operators and devices

For products not covered by an IVDD certificate and having a declaration of Directive compliance
-  Compliance with the Directive is maintained
-  No significant change in product design or destination
-  Application of the requirements of the IVDR Regulation in terms of post-market surveillance, vigilance and registration of economic operators and devices
-  The declaration of conformity is prior to May 26, 2022

3) Keys dates for placing* products on the market

For products covered by an IVDD certificate established before May 26, 2022:
-  Until May 26, 2025 if the IVDD certificate allows it

For products not covered by an IVDD certificate and having a declaration of compliance with the Directive established before May 26, 2022:
-  For future D classes, until May 26, 2025
-  For future C classes, until May 26, 2026
- For future sterile B and A classes, until May 26, 2027

*Placed on the market = has integrated the EU logistics/distribution circuit

4) Keys dates for the products reaching the end users

For products covered by an IVDD certificate established before May 26, 2022:
-  Until May 26, 2026

For products not covered by an IVDD certificate and having a declaration of compliance with the Directive established before May 26, 2022:
-  For future D classes, until May 26, 2026
-  For future C classes, until May 26, 2027
-  For future sterile B and A classes, until May 26, 2028
-  Beyond these dates, devices that have not reached the end user can no longer be marketed.

5) Products excluded from this new transition period

This amendment does not apply:

-  Nor to non-sterile class A devices (instruments, tampons, accessories, etc.): they must be compliant with the Regulations as of May 26, 2022
-  Nor to new products to be certified after May 26, 2022, regardless of the class of the device
-  Nor to products marked CE before May 26, 2022 and subject to significant changes of destination or design. These "Legacy devices" must be certified under IVDR to be able to apply these changes.

6) Caution for manufacturers:

-  A declaration of conformity under the IVDD Directive must exist or be established before May 26 2022 to be able to benefit from the transitional measures

-  The IVDD certificates (Appendix II, self-tests) will certainly have to be checked with its notified body in order to possibly plan their extension and the conditions for extension, in particular for those going up to May 26, 2024, date established according to the initial conditions before transitional measures. This work to modify the validity of the certificates must be carried out before the application of the lVDR, on May 26, 2022

-  Need to know the future class of products and for each reference, batches marketed before May 26, 2022, batches marketed after May 26, 2022 and benefiting from transitional measures, batches compliant with the IVDR.

-  Access to notified bodies remains very limited due to the number of notified bodies designated according to the IVDR in relation to the number of products to be certified

* REGULATION (EU) 2022/112 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices

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