It comprises seven questions relating to the implementation of Article 117 of the new Medical Devices Ordinance. The following questions, for example, are addressed:
The EU directives have been in force since 25 May 2017 and replace - after a transitional period - the three directives 93/42/EEC, 98/79/EC and 90/385/EEC. The MDR will be fully operational in May 2020, while there is still time until May 2022 to fully implement the IVDR.
Further accompanying documents are planned and the Q&A document will also be continuously supplemented.
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