ARTICLE SUMMARY:
In this week’s Pathways Picks: The latest EU notified body survey results show an acceleration in MDR activity and a slight deceleration in IVDR applications and certifications; a new guidance on European vigilance is published with more attention to diagnostics; approval of the EU health commissioner nominee is in doubt; and updates from the UK, Singapore, Malaysia, China, and ISO.
EU Picks
Activity report, Vigilance guidance, and Commissioner-designate updates:
MDR activity accelerates. The rate of new EU Medical Device Regulation application submissions to notified bodies and resulting certifications is increasing, according to the latest data from European Commission survey of notified bodies reported last week. Device firms had submitted 16,185 MDR applications and notified bodies had certified 8,905 of those devices as of June 30, representing increases of 28% and 27%, respectively, from the prior survey outcomes point in February. At that time, submission volume had grown only 14% from the prior data point and certifications had grown by 25%. Certifications include quality management system (QMS) certifications, which are required for most products, and product certifications, required for higher risk devices. Submissions and certifications also increased under the IVD Regulation, but the growth decelerated a bit in the latest report, with a 7% rise in applications (down from 10%) and an 18% rise in certifications (down from 25%). Other takeaways from the survey results reporting on activity through June:
