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...
MDR/IVDR Corrigenda Due Final Sign Off Soon; Big Changes For Devices, Less So For IVDs
The European Parliament is about to sign off corrigenda to the Medical Devices and IVD Regulations. The headline news is a longer transition period for a huge swathe of class I products, but there are other changes too.
Competent Authorities Drive Unilateral Eudamed Delay Decision Onto Council Of EU Agenda
The two-year delay to Eudamed was a Commission decision. Now the competent authorities are fighting back and the issue is to be discussed at the level of the Council of the European Union on December 9 to avoid “heavily burdensome administrative transitional solutions.”
EU Regulatory Roundup, November 2019: Big Changes For Medtech Regs Implementation
With six months left to the full implementation of the EU’s Medical Devices Regulation, there are a couple of big shifts taking place in the way it is being applied. Following news of the Eudamed database two-year delay, confirmation looks imminent that many more products will avoid having to comply with the MDR by next May. But will this plan sufficiently alleviate implementation pressures?
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: