EU Commission Releases Official Proposal to Extend the MDR Transition Period
6 January 2023
MDCG 2023-2: Guidance on Publishing Notified Body Fees
12 January 2023Switzerland is no longer part of the European Single Market, as most know by now. Therefore, the MDR Article 97 transitional provision outlined in MDCG 2022-18 does not automatically cross the EU-Switzerland border.
In their continued aim to implement EU equivalent legislation, Switzerland announced it will implement MDCG 2022-18: HERE
For a more thorough overview of MDCG 2022-18, please read: Guidance for MDD/AIMDD Manufacturers with Expiring Certificates
Per Swissmedic:
- Confirmations (“written communications”) from the responsible European medical devices authorities stating that they have granted a period of grace under MDCG 2022-18 will be accepted in Switzerland. The manufacturers’ Swiss authorised representatives (CH-REPs) are responsible for verifying these confirmations.
- In the absence of a confirmation by a responsible European authority, Swiss manufacturers and Swiss authorised representatives can inform Swissmedic of the certification gap. Assuming the conditions stipulated by MDCG 2022-18 are met, Swissmedic will accept a period of grace for restoring conformity and confirm this in writing.
The exact steps to submit are available in an Information Sheet located on the same page as the announcement.
The general process flow is outlined in the image below.
