Medical devices can only be placed on the market if the manufacturer has carried out the necessary conformity assessment procedure. For medical devices in moderate and high risk classes, the manufacturer must involve a designated/notified body, which will issue a certificate following a successful conformity assessment procedure.
A certification gap arises if a certificate issued under the old legislation as per Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) expires before the required certificate has been issued under the new regulation (MDR).
EU Position Paper MDCG 2022-18 describes a transitional solution for dealing with certification gaps. This will help to safeguard the supply of medical devices.
European market surveillance authorities can allow a period of up to 12 months to complete the MDR conformity assessment procedure. During this period, the authorities will tolerate the products in question being placed on the market without a valid certificate. This period as per MDCG 2022-18 can be granted if the conditions set out in the EU Position Paper are met. In particular, the manufacturer must already meet the MDR quality management system requirements, and there cannot be any safety concerns.
Switzerland is implementing equivalent medical devices legislation to the EU in order to ensure the same level of protection. MDCG 2022-18 is being implemented as follows in Switzerland:
- 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.
For more information, please see the information sheet: