|Theme||Interpretation of the transitional provisions for DM certified under the Directives|
|Target Audience||Manufacturers, Notified Bodies|
|Products concerned||MD certified under the directives (IVD excluded)|
MDR (EU) 2017/745
MDR – Article 120
MDCG 2021-13 rev.1
This guide on the transitional provisions applicable to certain CE marked devices under the DM and AIMD Directives overturns common misconceptions about the interpretation of Article 120 of Regulation (EU) 2017/745
A decisive distinction between “old devices” and “legacy devices” is made based on the guidance of the European Commission’s Blue Guide and MDCG 2021-13 rev1. To understand the provisions, it is important to keep in mind that the concept of placing on the market applies to each individual product and not to a product type.
The other “breakthrough” interpretation concerns the application of Article 86 of the MDR regarding the Periodic Safety Update Report (PSUR) for legacy devices. Manufacturers must comply with the requirements that concern them. However, there is no periodic transmission of the PSUR to the Notified Body. The examination of the PSUR is carried out during the surveillance audits provided for in Article 120§3.
A table summarising the requirements is provided at the end of the guide, so don’t hesitate to consult it!