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

How One EU Notified Body Transitioned From The Directives To The MDR And What The Change Means For Clients

 
• By Amanda Maxwell

Less than two months after the MDR applied in the EU, GMED’s Tarik Krim explains how his notified body navigated the early phase of the transition from auditing the directives to the regulation, and how the change has impacted its clients and demand for services.

Imagination idea and transition concept as a leaf changing to a butterfly shape as a fantasy travel and amazing inspirational spirit symbol in a 3D illustration style.
Transitioning from the EU directives to the MDR

The run up to the full implementation of the EU Medical Device Regulation was a period of intense activity and change for notified bodies, which, among other things, had to seek designation against the new rules and adjust from testing against the medical device directives to the much stricter requirements of the MDR.

It has been a challenging time, not least because certain aspects of the new regulation, such as standards and the...

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

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

 
• By Natasha Barrow

NHS England's national 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

Award-Winning Lioness Implant Addresses ‘Silent Emergency’ Of Preterm Birth

 
• By Ashley Yeo

The Lioness non-surgical silicon ring implant is designed to put an end to pre-term births, sparing maternal anguish and saving health system costs. PregnanTech won the Biomed Israel 2025 medtech start-up award, and Limor Sandach told In Vivo how a non-digital technology beat off stiff competition.

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.