Backlog on EU standards mounts as Commission takes hard line
This article was originally published in Clinica
Executive Summary
The European Commission is slowly and methodically reviewing a whole raft of updated harmonized EU standards, but there is now a backlog of work building up and it seems that it could be some time before work that has already been carried out at CEN, the European Committee for Standardization, is officially recognized.
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.