ENGLISH 25 We have good experience with authorities and Notified Bodies thanks to our adequate qualifications in the areas of Good Laboratory Practice (GLP), risk management and testing activities. (Professional) experience in biological GLP laboratories, ISO 17025 accredited testing and assay facilities, as well as regulatory affairs concerning medical devices stand as sound proof of competence. Relevant university degrees are also welcome. Broadly speaking, it is fair to say that reporting in this form is becoming an increasingly important component in the regulatory requirements for medical devices. The “plan – execution – report” structure is already included in other areas of regulation, such as validation or risk management. The purpose of summarised reports is to make it easier for authorities and Notified Bodies to review and classify the information and results collected. At the same time, they help manufacturers to keep track of the completed tests and processes as well. Europe and Switzerland – Quo vadis? The new EU regulations 2017/745 and 746 have significantly tightened the regulatory requirements for medical devices in Europe. Special regulations for Switzerland are now on their way. Switzerland and the European Union had a Mutual Recognition Agreement (MRA) before the new regulations were introduced. But Switzerland stepped back from the negotiations, which means that there will be no new MRA. The EU will therefore treat Switzerland like any other third country. What effects will this have on European companies and instrument manufacturers? Switzerland, for its part, is now demanding additional regulatory requirements as well. For example, the Swiss Medical Devices Ordinance (MepV) insists on the appointment of a “Swiss Authorised Representative” (CH-Rep) for companies that are domiciled outside of Switzerland. The CH-Rep must have its registered office in Switzerland. Their duties are comparable with those of an EU authorised representative. At the same time, the competent Swiss supervisory authority, Swissmedic, no longer has access to the EUDAMED system. This means that the traceability of medical devices on the Swiss market has been lost. As a result, registration with Swissmedic is now obligatory for manufacturers, distributors and importers. Registration must take place no later than 3 months after the device was first placed on the market. Reports of serious incidents to Swissmedic must
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