18. December 2019

The guidance MDCG 2019-15 includes a comprehensive overview of the manufacturers‘ obligations for all Class I products. It also gives some further clarification concerning the "Authorized Representative": A manufacturer with a registered place of business outside the Union will designate a sole authorised representative, at least per each generic device group, according to a written mandate. At the same time it includes further specifications of the manufacturers' obligations: The...

16. December 2019

The long awaited second corrigendum (MDR COR 2) english Version of the COR 2 German Version of the COR 2 other languages Version of the COR 2 is now finally "deemed to be approved" by the EU-Parliament as there was no further request on voting on the ENVI Document during the meeting held on December 16th in Straßburg. It was handled as TOP 6 of that meeting and results with the following statement in the protocol: 6. Corrigenda (Rule 241) The ENVI and INTA Committees had forwarded the...