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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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.
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.
Originally intended to increase medical device safety, the EU’s medtech regulation is so hampered in its implementation that it is now arguably a bigger potential threat to patients than any of the scandals leading to its more stringent requirements.