Medtech Insight has already focused on six of the key changes in the parliament’s proposal to the European Commission. This article looks in further depth and breadth at the changes which, if taken up, are designed to ease the regulatory burden in the EU, support SMEs and innovation. and result in fewer products being removed from the market.
The scale of the changes in the European Parliament’s proposal for an amending legislation to the Medical Device Regulation to the European Commission is impressive and the result of large-scale, in-depth work.
The proposal, which reflects many of the points that have been raised over the last year by stakeholders, including industry...