European Regulatory Roundup, September 2022: Stakeholders Start Taking Radical Decisions
Executive Summary
The regulation of clinical evidence and cybersecurity as well as lack of auditor availability were among the topics causing most concern to the medtech industry in September. But obstacles to the smooth implementation of the Medical Device and IVD Regulations persist and some actors are taking matters into their own hands.
You may also be interested in...
First Revision Of EU Medtech Standardization Mandate Due Early 2023
Work is progressing towards publications of an updated list of standards to support implementation of the EU’s new medtech regulations.
MedTech Europe Calls For EU To Amend Regulation To Allow For eIFU For Low-Risk Devices
The EU needs to go further when it comes to allowing the use of electronic IFU for all professional use medical devices and fall more closely into line with other global markets.
EU Medtech Industry Awaits Outcome Of MDCG’s Urgent Meeting With Bated Breath
Will the EU agree that Article 97 is the way to go to avoid notified body bottlenecks in the context of the Medical Device Regulation? This matter is now being reviewed at the highest levels.