03. April 2020

The commission published the "Proposal for ... amending Regulation (EU) 2017/745" which will defer certain provision of the Regulation by one year. At the same time it will defer the date of repeal of the directives 90/384 EEC and 93/42/EEC by one year. The Article 1 of the Amendment postpones the implementation of the following aspects form 26. May 2020 to 26. May 2021: Publication date für common specifications for Annex XVI products Publication date für common specifications for...

04. August 2017

The transition periode for using the old ISO 13485:2003 will end on 2019-03-01