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...