You might be aware, in the context of pending agreements between Switzerland and the EU, there are certain modifications/amendments made to the Medical Devices Ordinance (MedDO) and the Federal Council approved supplementary provisions for implementing medical device regulations, which are in force since May 26, 2021. These provisions are designed to offset the negative consequences in the absence of an MRA (Mutual Recognition Agreement) update and to ensure a sufficient supply of medical devices to Switzerland. Let us know more about these amendments.
As per the new MedDO amendment, in the absence of an updated MRA, mutual market access to medical devices, trading of medical devices, coordinated market surveillance activities and the sharing of information between the authorities or the mutual recognition of certificates of conformity will be affected. Swissmedic will be denied official access to the central European database for medical devices (EUDAMED 3), without an updated MRA. Swissmedic does not have access to implementation-related data and is excluded from the working groups on the joint surveillance of new medical devices. Starting from May 26, 2021, the Swiss manufacturers have already started appointing authorized representatives to market their products in the EU. Simultaneously, the Switzerland – EU agreement on the mutual recognition of certificates of conformity also needs to be updated. As part of the alignment of Swiss medical devices legislation to the new EU MDR, Swissmedic has already implemented the following changes:
Unique Identification Number: Upon request, Swissmedic assigns the Swiss Single Registration Number (CHRN) to Swiss manufacturers, authorized representatives and importers. The CHRN number is a unique identification number that is used to identify a manufacturer, authorized representative or importer. Swissmedic cannot assign a European Single Registration Number (SRN) via EUDAMED for economic operators who are domiciled in Switzerland until the MRA (Mutual Recognition Agreement) is updated. Therefore, manufacturers, authorized representatives and importers domiciled in Switzerland must register with Swissmedic to mitigate the consequences of loss of information and continue to ensure market surveillance in Switzerland. The economic operators must register within three (03) months of placing their first product on the Swiss market to avoid delays in bringing compliant products to market and prevent supply bottlenecks in Switzerland.
Reporting Incidents and Field Safety Corrective Action (FSCA): In Switzerland, the incidents that have occurred and are classed as serious must be reported to Swissmedic, even in the absence of access to EUDAMED3. Swissmedic will systematically collect and evaluate the reports of the incidents to protect the health of patients and users. Particularly, the system aims to avoid recurrences of serious incidents attributable to problems that can be traced to the design, manufacture or use of medical devices. Manufacturers may have to initiate an FSCA if a problem occurs with the medical device and Swissmedic will monitor all the FSCAs involving the medical devices placed on the Switzerland market.
Clinical Trials of Medical Devices: The Human Research Act (HRA) and Ordinance on Clinical Trials with Medical Devices (ClinO-MD) define the corresponding requirements for clinical trials of medical devices and for devices without a medical purpose, as listed in Article 1 of the Medical Devices Ordinance (MedDO). Clinical trials fall under the category C in case:
- if the medical device carries a CE-mark but will not be used in accordance with the CE-marked instructions for use (off-label use, Category C1), or
- if the medical device is not CE-marked (C2), or
- when a medical device’s market-entry or use is prohibited in Switzerland (C3)
These “pre-market” trials require the authorization of Swissmedic and the cantonal ethics committee and the applications for authorization must be sent on the same day to the ethics committee (BASEC portal) and Swissmedic (eMessage portal). The other trials with medical devices require only the authorization of the cantonal ethics committee (category A clinical trials) and do not need to be submitted to Swissmedic. For in-vitro diagnostic medical devices, clinical trials are still regulated by the Clinical Trials Ordinance (ClinO) and will be included in the ClinO-MD.
As the MedDO changes have come into force on May 26, 2021, medical device manufacturers willing to enter the Swiss market must understand the amendments and ensure to align with them in their processes for successful compliance. To know more about Swissmedic’s medical device regulations, consult a regional Regulatory expert. Stay informed. Stay compliant.