EC Releases Document On Device Shortage Reporting Obligations

Device supply interruptions and withdrawals, now common in the EU, could threaten patient safety. Newly issued manufacturer guidance from the European Commission is intended to improve transparency and minimize disruption.

Illuminated sign that reads "Out of Stock."
(Maridav/Shutterstock)

The European Commission has issued a 12-page Q&A document on the new article 10A of the Medical Device Regulation and IVD Regulation which obliges manufacturers to provide information about any anticipated interruption or discontinuation of device supply. The provision will apply from 10 January 2025.

These measures are recognized as critical to head off problems that can arise for physicians and patients where a device...

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

More from Medtech Insight

Dermal Fillers For Décolletage May Gain FDA Approval

 
• By 

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.

South Korean Health Ministry Sees Benefits Of Pre-Regulatory Review

 
• By 

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

 

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.

Execs On The Move: June 23–27, 2025

 
• By 

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

More from Regulation

EU Life Sciences Strategy Must Address ‘Regulatory Lasagna’

 

MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”

FDA Publishes Final Cybersecurity Guidance To Replace Final Cybersecurity Guidance

 

The US FDA has issued an updated final guidance document on cybersecurity considerations for medical device manufacturers that replaces a previous final guidance the agency issued in 2023.

New Regulation Significantly Expands eIFU Usage Scope

 

Amendment brings new benefits for device accessories and aesthetic devices used by healthcare professionals.