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...

16. March 2020

Although the strategy for the transition to the MDR should be "NO CHANGE" on any device that shall be sold utilizing the MDD Certificate after 2020-05-26 (so called "legacy devices") the original wording given in the MDR is "NO significant change". With the newly published MDCG 2020-3 the EU Commission published further clarification on how to interpret the phrase "significant change" for products under Art. 120. Like comparable Guidances in the USA, Canada, Singapore etc. the Guidance is using...

15. January 2019

The European Commission published new Templates for Manufacturers to report Serious Incidents under the MDR/IVDR and Incidents under the MDD/AIMDD/IVDDD. This does not only include an integration of the new legislation but it also strengthens the internal harmonized communication concerning incidents by also using the global harmonized categories published by the IMDRF. As a consequence the template now includes 12 pages.... The version 7.1 of the Template now also integrates the new aspects...