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Making The Leap From EU MDD To MDR Clinical Evidence (Part 3): Critical Questions Answered

 
• By Amanda Maxwell

Do you know how to avoid the pitfalls when it comes to clinical evidence under the MDR? Or whether evidence gathered outside the US counts? Amie Smirthwaite of Maetrics answers these and other pivotal questions in this third and final part of an interview series with Medtech Insight.

Labyrinth

All manufacturers wanting to be compliant with the new EU Medical Device Regulation, when it fully applies from 26 May 2021, must review their clinical evidence in the light of the new rules. Picking a way through the new MDR requirements it not always easy.

Here, Maetrics’ Amie Smirthwaite explains the potential compliance pitfalls, when a claim of equivalency can be used and how well...

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More from Europe

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 
• By Natasha Barrow

The NHS England chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

EU/US Trade Deal Raises Questions For Medtech

 
• By Amanda Maxwell

There is still no clarity on how life sciences will be treated in the final agreement.

NICE To Consult On UK Late-Stage Healthtech Assessments

 
• By Ashley Yeo

NICE’s three-pronged lifecycle approach to healthtech evaluations includes late-stage assessments (LSA), which will be the focus of a short consultation in August.

Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 
• By Amanda Maxwell

In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.

More from Geography

Boston Scientific Raises Outlook … Again: Headwinds Offset By EP And Watchman

 
• By Natasha Barrow

Agent drug coated balloon, Watchman product sales, and electrophysiology (EP) business unit growth offset Acurate discontinuation and tariff headwinds. CEO Michael Mahoney shouted out coronary therapies business and answered questions on CMS proposed Ambulatory Surgical Center codes.

FDA ‘Regulatory Accelerator’ Aims To Speed Digital Health Development

 
• By Elizabeth Orr

The US FDA has launched the Regulatory Accelerator to expedite digital health product development. This includes resources like a Resource Index for Innovators, a Medical Device Software Guidance Navigator, and best practices for early meetings.

From ‘Work Harder’ to ‘Phenomenal People’: Makary’s FDA About-Face

 
• By Michael McCaughan

In his first 100 days as FDA commissioner, Martin Makary has gone from vocal critic to vocal supporter of the agency’s staff, calling them “phenomenal” and praising their dedication—even as morale remains shaken by recent layoffs and restructuring.