EU: MDCG guidance on changes to "legacy devices" in accordance with Article 120

The MDCG has issued a new guidance document (MDCG 2020-3) relating to the question of assessing significant changes to products that have been placed in the market in accordance with the further-reaching transitional provisions in Article 120 MDR.

The document contains general specifications in annexes, as well as flow diagrams regarding general decision-making and additional questions (changes to the intended purpose, changes to the design or performance, changes to software, changes to material, and changes to sterilisation procedure or sterile packaging).