Latest EU medtech proposals take a different view on fees
This article was originally published in SRA
Executive Summary
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 Commission1,2. 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.
You may also be interested in...
EU Regulatory Roundup, March 2024: Busy Agenda In Broad Range Of Key Areas
March was an important month for EU medtech regulation with an interesting spread of news relating to the Medical Device and IVD Regulations, the Batteries Regulation, the Artificial Intelligence Act and more.
EU’s Revised Phthalates Guideline Features New Annexes Focused On Alternatives
The effects of phthalates, plasticizers used in many medical devices, on the human endocrine system, have long been debated. But how safe are the alternatives? Updated guidelines give more insight.
Non-Medical Brain Stimulation Devices: Could They Be Down-Classified Again In the EU?
Six types of products that do not have an intended medical purpose fall under the scope of the Medical Device Regulation. Understanding their risks is complex and subject to regular re-examination by the European Commission.