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

Over 170 Provisional Draft Codes Published For Notified Body Designation Under MDR & IVDR

 
• By Neena Brizmohun

Three new draft documents relating to notified bodies list the codes being prepared to determine their scope of responsibility for designation under the new EU medtech regulations and the raft of documentation they will be asked to submit when they apply for redesignation.

The European Commission’s Notified Body Operations Group has published two draft lists comprising 171 codes that might be used to determine a notified body’s scope of designation under the new EU medical device and IVD regulations. NBOG has also released a third document – a draft list that signals the breadth of documentation notified bodies might be asked to provide when it comes to applying for redesignation under the new regulations.

The lists, which were published in August, have not yet been adopted or endorsed by the commission and must not...

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 Approvals

Medtronic Announces Collaboration To Create A ‘New Era’ in Surgical Training

 
• By Brian Bossetta

Medtronic is teaming up with IRCAD North America to build high-tech training and education experiences for surgeons and medical professionals in cardiovascular, neuroscience, and minimally invasive surgical specialties. The move could also further position Medtronic to seize on the growing robotics

First AI Breast Cancer Prediction Platform Receives FDA Authorization

 
• By Natasha Barrow

Clairity’s "first-in-class" mammography-based AI screening tool, Clairity Breast, provides "equitable risk assessments," expanding access to lifesaving early detection for breast cancer, said company founder Connie Lehman.

Abbott Announces FDA Approval Of Tendyne Transcatheter Mitral Valve Replacement System

 
• By Marion Webb

Abbott received the US FDA nod for its Tendyne system, offering a minimally invasive alternative to replace the valves of patients with severe mitral valve disease who are at risk for open-heart surgery.

First At-Home Cervical Cancer Screening Tool Gets FDA Clearance

 
• By Elizabeth Orr

The US FDA has approved the Teal Wand, the first at-home cervical cancer screening device. Capable of detecting preclinical cancer with 96% accuracy, it will launch in California in June and expand nationwide soon after.

More from Policy & Regulation

FDA’s AI Tool Won’t Make Regulatory Decisions, Official Says

 
• By Cathy Kelly

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.

MHRA Opens Second AI Airlock Program For Applications

 
• By Natasha Barrow

"The AI Airlock program creates a supervised testing ground where novel technologies and challenge areas can be safely investigated," said James Pound, MHRA interim executive director of innovation and compliance.

Medtronic Announces Collaboration To Create A ‘New Era’ in Surgical Training

 
• By Brian Bossetta

Medtronic is teaming up with IRCAD North America to build high-tech training and education experiences for surgeons and medical professionals in cardiovascular, neuroscience, and minimally invasive surgical specialties. The move could also further position Medtronic to seize on the growing robotics