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 flow-charts to support the decision on the significance of the change.
These five flow-charts start with:
- A) Change of intended use
- B) Change of design or performance specification
- C) Software Change
- D) Material Change
- E) Change of sterilization / packaging
However the core statement in the MDCG 2020-3 is:
- It is important to highlight that no issuing of new MDD/AIMDD certificates, including modified, amended or supplemented certificates, is allowed under MDR Article 120(3). In particular, if the manufacturer wishes to make a “significant change in design or intended purpose” under MDR Article 120(3), the implementation of such a change would prevent the manufacturer from continuing to place that device on the market under the Directives.
It is highly recommended to follow the core statement in order to avoid never ending discussions on " is this change significant or not", that may last longer than than the remaining validity of the MDD certificate.