French Government Will Tell Commission To Give Notified Bodies Time To Process All Files

Despite proposals to alleviate the threat of medtech products being unnecessarily removed from the EU market when their old certificates expire, concerns remain at the highest level and calls for action persist.

Loudspeaker

Local reports indicate that the French government is today officially requesting the European Commission to postpone the 26 May, 2024 date by which all medical devices, even those that have made use of the transition period, must comply with the Medical Device Regulation.

While no official statement had been made by the French government as Medtech Insight went to press, industry association, MedTech...

More from Europe

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.

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.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it. 

More from Geography

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.

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

 
• By 

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.

Planning To Take Part in MDUFA? FDA Wants To Hear From You

 

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.