Medical devices - Switzerland as a third country

On 26 May 2021, the worst-case scenario became a reality - Switzerland became a third country for the trade of medical devices without a valid MRA (Mutual Recognition Agreement). Medical devices that still have a valid certificate according to MDD or those that have already been certified or declared compliant according to MDR continue to have access to the Swiss market. However, concurrent with the transition to third country status, Swissmedic no longer has access to the information in the EUDAMED database as so changes to the previously established procedures are needed at very short notice. For example, the economic operators already marketing medical devices (importers, manufacturers, Swiss Authorised Representatives (AR) as soon as available) must be notified to Swissmedic by 26 November Importing companies must - graded according to risk class - ensure within a very short time that their manufacturer appoints a Swiss AR. For class III products, this is mandatory by 31.12.2021, for class IIa and IIb by 31.3.2022, for class I products by 31.7.2022, in order to maintain marketability in Switzerland. The Swiss AR must be indicated on the packaging/product, but not on the IFU or the accompanying documents. Information related to the design can be found here. Therefore, importing companies should quickly contact the partner companies, that manufacture the medical devices for them, in order to discuss how to proceed and to appoint and contract a Swiss AR – or in the case of emergency, to look for substitute products,. SWISS MEDTECH provides useful guidance and information; sample contracts for Swiss representatives can be requested.