Fees under new Medical Device Regulation: Council of EU paints a different picture
This article was originally published in Clinica
A detailed analysis of the Council of the EU’s recently published amendments to the proposed Medical Device Regulation reveals that the council’s views on fees which manufacturers have to pay to meet the new requirements diverge significantly from those of the European Commission. The council is also wanting EU “expert panels” and “expert laboratories” to take over the role of existing EU reference laboratories but with slightly different responsibilities.
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