Overdue Revision Of EU Cancer Screening Would Benefit Medtech Industry As Incidence Skyrockets
Council of the EU recommendations on cancer screening have not changed in some 20 years, yet the increase in cancer rates is alarming. Industry associations, COCIR and MedTech Europe have come out in support of the European Commission’s push for a revision.
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New designations of notified bodies under the Medical Device Regulation continue to trickle through slowly. The latest brings the EU’s total to 33, still way short of the previous 80 or so under the Medical Devices Directive.
Changes have occurred in the management focus within the European Commission’s directorate responsible for medtech but not within the devices leadership; familiar faces remain.
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.