1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

An Auditor's Take: Unrealistic EU Demands Are Causing Notified Body Exodus, Potential Company Collapses

 
• By Amanda Maxwell

Demands related to auditor education, experience and affiliation are making it difficult for notified bodies to retain and hire staff. This comes on top of much tougher regulatory requirements. One notified body auditor explains why the situation might be killing notified bodies when they are needed most.

Medtech Insight’s headlines have frequently focused on new tougher requirements for notified bodies that have come into place since 2013, and there is no sign that trend is letting up. Few individuals have been as frank and outspoken about the issue as Daniel Shoukier, lead auditor at notified body SQS, Switzerland

He provided his personal opinions on the matter at KNect Drug Device Combination Product meeting (convened by Medtech Insight publisher...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

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

 
• By Natasha Barrow

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

 
• By Amanda Maxwell

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

Commission Decision Launches Pediatric And Rare Disease Expert Group

 
• By Amanda Maxwell

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

Dermal Fillers For Décolletage May Gain FDA Approval

 
• By Elizabeth Orr

An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.

More from Policy & Regulation

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

 
• By Brian Bossetta

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

 
• By Amanda Maxwell

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

Dermal Fillers For Décolletage May Gain FDA Approval

 
• By Elizabeth Orr

An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.