Responsibility for medical device regulations is set to move from DG GROW to DG SANTE. The announcement was made by European Commission President-elect Ursula von der Leyen as she named her new team of Commissioners who will take over their portfolios in 2020.
Stella Kyriakides, a Cypriot medical psychologist, is to lead on health. In her letter to Kyriakides, von der Leyen wrote, “I want you to focus on the effective implementation of the new regulatory framework on medical devices to protect patients and ensure it addresses new and emerging challenges.”
Considerable concerns remain as to the feasibility of the MDR being successfully implemented in sufficient time to allow manufacturers to comply and get their products through the certification system.
Announcing the reallocation of portfolios for the various Directorates Generale, the Commission says, “The relevant part of Unit GROW.D.3 (Biotechnology and Food Supply Chain), dealing with pharmaceuticals, moves from DG GROW to DG SANTE – The relevant part of Unit GROW.D.4 (Health Technology and Cosmetics), dealing with medical devices, moves from DG GROW to DG SANTE.”
Responsibility for medical device regulation has moved back and forth between DGs in the past, so there may well be no need for any undue concern other than how the change might affect the ongoing implementation work.