Eighteen months have passed since the application date of the medical device regulation in May 2021, and the challenges posed by the transition still define our everyday life.
Many manufacturers of class I medical devices have made succesfull transitions to MDR. However, some manufacturers of certain class I medical devices are struggling with the challenges posed by the transitional provisions in article 120 (3) and (4) of the MDR. This newsletter includes a short summary of the guidance in MDCG 2020-2, to help manufactures navigate these transitional provisions.
Another interesting topic is the ongoing update of the international standard for biological evaluation of medical devices, ISO 10993-1. This newletter includes a short briefing of the update written by one of our consultants.