Damage to SMEs and innovation, overly high notified body costs and concerns over lack of surveillance for critical devices are all topics addressed among responses to the European Commission’s latest MDR proposal.
As Medtech Insight went to press, over 175 comments had been made by stakeholders to the European Commission’s proposal to introduce extended transition periods for legacy devices, with the deadline due to expire at midnight on 18 January.
Concern about barriers to innovation features high among the topics that jump out from some of the most recent feedback.
A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.
An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.
A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.
