01. Juli 2021
Seit dem 26. Mai 2021 ist die MDR in Kraft. Die Schweiz hat das Rahmenabkommen und das Mutual Recognition Agreement mit der europäischen Union nicht unterzeichnet. Somit ist die Schweiz ein Drittstaat bei der Annerkennung von Zertifizierungen von Medizinischen Produkten in der EU und braucht deshalb einen EU-REP. Hersteller welche innerhalb der EU sind, müssen für den Vertrieb der Produkte in der Schweiz einen CH-REP benennen. Die Aufgaben und Anforderung für die Wirtschaftsakteure seit dem...
27. Mai 2021
Swiss medtech industry has been downgraded to «third country» equivalency. From now on, Swiss companies will have to meet stricter requirements when exporting their medical devices to the EU. The Swiss medtech industry has worked hard to prepare for this day as best possible. The new EU Medical Device Regulation (MDR) replaces the existing EU Directives (Medical Device Directive, MDD) and the corresponding Swiss medical device legislation enters into effect. When the MDR comes into force, the...
28. Dezember 2020
In about 3 months, the MDR will come into force. Much remains to be done. If Switzerland has not a finalized Mutual Recognition Agreement which is a part of the bilateral agreements, Swiss medical device manufacturers needs to define an EC Authorized Representative (Economic Operator), which is located in an EU country . From May 26, 2021, medical devices must be certified according to MDR regulations. Devices still certified under the MDD may be placed on the market until May 2024 if no...