1. Medtech Insight
  2. >>Geography
  3. >>Europe

Drug/Device Combinations: New Position Paper Explains Notified Body Responsibilities

 
• By Amanda Maxwell

Medicinal products authorities will consider a medtech notified body opinion on the device element of a drug/device combination product. A new position paper explains how roles and responsibilities are shared between medtech and medicinal product experts.

Puzzle_Pieces_Teams

The EU’s medtech notified body association, TEAM-NB, has issued a position paper on documentation requirements for drug/device combination products, which also explains the extent of the notified bodies’ remit with products that also fall under medicinal product legislation.

The document focuses on products that fall under the scope of Article 117 of the EU’s Medical Device Regulation (MDR).

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 Europe

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.

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.

Thena Capital’s New Fund Up And Running With £1M Investment In Plexāā’s Breast Cancer Device

 
• By Natasha Barrow

Thena Capital, the first UK-based early-stage specialist medtech firm, has made its first investment since closing its £50m fund. Medtech Insight spoke with general partner Pamela Walker Geddes to gain insight into Thena Capital’s investment strategy.

More from Geography

South Korean Health Ministry Sees Benefits Of Pre-Regulatory Review

 
• By Jung Won Shin

A system of pre-regulatory review consultations for innovative drugs and devices in South Korea has contributed to the accelerated development of such products.

Thena Capital’s New Fund Up And Running With £1M Investment In Plexāā’s Breast Cancer Device

 
• By Natasha Barrow

Thena Capital, the first UK-based early-stage specialist medtech firm, has made its first investment since closing its £50m fund. Medtech Insight spoke with general partner Pamela Walker Geddes to gain insight into Thena Capital’s investment strategy.

Court Orders US FDA To Return Trial Diversity Action Plan Guidance To Website

 
• By Sue Sutter

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.