Following the Council’s agreement on the new measures to implement the Medical Devices Regulation (MDR), the Medical Device Coordination Group (MDCG) published a position paper on the application of article 97 in December 2022. Article 97 addresses non-compliance of medical devices and consequent related actions of the Member States. Specifically, this Paper (namely MDCG 2022-18) focuses on the application of Article 97 of the MDR to legacy devices for which the Directives’ certificate expires before the issuance of an MDR certificate.
In January 2023, Swissmedic, the Swiss Agency for Therapeutic Products, published a document on the application of MDCG-18 in Switzerland.
Certificate gaps according to MDCG 2022-18 in Switzerland
When a CE Certificate issued under the previous Directives expires, Member States will be able to allow manufacturers to keep selling their devices, giving them a certain time frame to bring their devices into compliance. In Switzerland, the process will foresee the following:
- If the certificate has expired and there is a written communication of an EU/EEA competent authority for an extended period, the Swiss Authorised Representative will have to verify the presence and validity of this communication. In this case, the EU/EEA competent authority will conduct the surveillance.
- If the certificate has expired and there is no written communication for an extended period, the Swiss manufacturer or the Swiss Authorised Representative (CH-REP) can apply as described in MDCG 2022-18. Swissmedic has to be notified and will be in charge of the evaluation. Two scenarios might follow:
- Swissmedic evaluates if the device meets the conditions for a period according to MDCG 2022-18. Particularly, the device does not have to represent a risk to health and safety. In such cases, Swissmedic grants a period to re-establish conformity as described in MDCG 2022-18. In this case, Swissmedic will conduct the surveillance.
- Swissmedic evaluates that the device does not meet the conditions for a period according to MDCG 2022-18. Consequently, it will be prohibited to place the device on the market. If necessary, Swissmedic can also order a recall.
Reliance on MDCG 2022-18 confirmations of EU/EEA member states
The Competent Authority of an EU/EEA country issues a written confirmation as per Article 97 MDR in case the devices meet the necessary requirements. Manufacturers or other economic operators can use this communication to prove to other EU/EEA countries that the medical device can be placed on the market despite the non-conformity.
Generally, Switzerland recognizes this communication. On these terms, a notification to Swissmedic is not necessary. The CH-REP will verify and keep available the appropriate conformity assessment procedure. Additionally, the CH-REP will verify and keep available the written communication issued by the EU/EEA country.
Market Surveillance procedures and notification in Switzerland
In Switzerland, Article 97 of the MDR (or Article 75 of the MedDO) describes the market surveillance activities of Swissmedic. In case of certification gaps, Swissmedic will handle the notification of a certification gap. The notification occurs via email and some of the information to provide are:
- Details of the Swiss manufacturer or CH-REP
- List of devices
- Documents according to the Annex of MDCG 2022-18
- Disclosure on notifications according to MDCG 2022-18
- Disclosure of any measures according to Art. 94-97 MDR
When there is no written communication from an EU/EEA, the Swiss manufacturer or the Swiss Authorised Representative (CH-REP) can submit the application. If Swissmedic accepts the application, manufacturers usually have 12 months from the certificate’s expiration date to end the non-compliance.
Swissmedic charges fees for this administrative procedure, which depend on the time spent on the procedure. The hourly rate is CHF 200.