EU Notified Body MDR/IVDR Certificates Data: A Slow-Motion Car Crash

Warnings about lack of notified body capacity to certify products against the EU’s new medtech regulations have become likes waves repeatedly crashing on the shore. With 19 months to go until the absolute deadline for MDR compliance, the latest figures appear alarming.

Windstorm Friederike (2018) (Jens Meyer/AP)
(Jens Meyer/AP)

In total, 1,990 conformity assessment certificates have been granted to date under the EU’s Medical Device Regulation, according to just published official EU figures.

In all, 8,120 applications had been made to notified bodies for the assessment of products under the Medical Device Regulation...

More from Europe

HealthAI: ‘Established Regulations Already Exist For Regulating AI In Healthcare Safely’

 

Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.

FDA Greenlights Expanded Use Of Boston Scientific’s Pulse Field Ablation System

 

A recent approval from the US FDA allowing Boston Scientific to broaden its labeling for its pulse field ablation system means more patients with one type of AFib will have access to a promising new treatment.

Commission Decision Launches Pediatric And Rare Disease Expert Group

 

A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.

More from Geography