24 Jan 2020
The draft standardisation request for MDR and IVDR was submitted to the Committee on Standards with the need to provide an adequate legal basis for the development of harmonised European standards and been issued to CEN and CENELEC, the European Standardisation Organisations.
Annex I of this request lists the existing standards to be revised, and new standards to be drafted under the MDR while Annex II of this request lists the existing standards to be revised, and new standards to be drafted under IVDR

20 Jan 2020
Swiss Medtech recommends Swiss medical device manufacturers to fulfill requirements of a third country manufacturers at the 26 May 2020. This means especially to have an Authorized Representative in place. Read more

11 Dec 2019
Swiss Medtech recommends to manufacturers to prepare on worst case scenario regarding situation with Mutual Recognition Agreement.
Have you already considered to work with service provider EUmediq as Authorized Representative? Read more