Very Few Outstanding Items On European Commission’s Shrinking Rolling Plan
Most items have been ticked off the commission’s implementing plan now; but among the four items left, there is also a new proposal for an implementing regulation for Annex XVI products.
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European Commission Expects Eudamed To Be Fully Ready By Q2 2024
The European Commission has published an updated timeline for delivering the EU medical device database. Regarded as the cornerstone of the EU medical device and IVD regulations, the Eudamed database will have been delayed by four years and there are transition periods ahead.
EU Offers Insight On New MDR Guidance Documents On The Horizon
The EU Medical Device Regulation has been in force for a year and the IVD Regulation applied a few weeks ago. Many vital guidance documents have been in the pipeline for considerable time but will be made available later this year.
MDR Amending Regulation Officially Published And Already In Force
The deadlines for legacy products under the Medical Device Regulation have changed. Here are the essentials that all medtech players need to understand in how the MDR has now been amended.