MDR Transitional Provisions.pdf

The Common Specifications (CS) are applicable to Annex XVI products from 22 June 2023.
The MDR is applicable to Annex XVI products from 22 June 2023.
Transitional provisions include a fixed period of 6 months (from 22 December 2022 to 22 June 2023) and dedicated provisions for specific cases.
For products covered by a valid MDD certificate, transitional provisions apply until the certificate's validity expires.

Transitional Period for Products with Notified Body Involvement and Clinical Investigation

The transitional period is approximately 6.5 years (from 22 June 2023 to 31 December 2029).
Conditions to be satisfied during this period include:
+ The product was lawfully marketed in the EU before 22 June 2023 and continues to comply with applicable requirements.
+ The manufacturer does not make significant changes to the product's design and intended purpose.
+ The sponsor receives confirmation of the clinical investigation's completeness and scope (by 22 June 2024).
+ The sponsor starts the clinical investigation (by 23 December 2024).
+ The manufacturer signs a written agreement with a notified body for the conformity assessment procedure (by 1 January 2028).

Transitional Period for Products with Notified Body Involvement and No Clinical Investigation

The transitional period is approximately 5.5 years (from 22 June 2023 to 31 December 2028).
Conditions to be satisfied during this period include:
+ The product was lawfully marketed in the EU before 22 June 2023 and continues to comply with applicable requirements.
+ The manufacturer does not make significant changes to the product's design and intended purpose.
+ The manufacturer signs a written agreement with a notified body for the conformity assessment procedure (by a specific date).