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Set Alert for Policy and Regulation - Europe

Optimizing EU Medtech Regulatory Governance And Innovation: First Workshop Shapes Future Study

Work related to the European Commission’s promise to assess the impact of the Medical Device Regulation, including its impact on innovation, is starting to take shape.

Europe EU

Exciting New Opportunities Launched In UK For Innovative Products As IDAP Gets Underway

Medtech developers have just over a month to apply for the pilot phase of a program offering regulatory and practical support to accelerate innovative product access to the UK NHS.

Europe United Kingdom

Entire EU Medtech Industry Throws Weight Behind Argument To Structurally Reform MDR And IVDR

The European Commission has conceded to the medtech industry’s calls to delay and modify the new EU regulatory requirements multiple times over the last few years. But will it yield to fresh calls for radical changes being sought by the most powerful lobby yet?

Europe EU

Finland’s Eurofins Becomes EU’s 11th Notified Body Designated Under the IVDR

The number of notified bodies designated under the IVD Regulation has now crept up to 11 as the first Finnish designation is announced.

EU Europe

Taking Steps Towards Improving Innovation Opportunities In The EU Regulatory Environment

The German notified body, TÜV SÜD, is looking to help create a more favorable regulatory environment for medtech innovation within the EU as the debate continues over damaging MDR/IVDR implementation practices.

Europe EU

UK Considers US -Style Payment Reporting Obligations For Drug And Device Firms

The UK pharmaceutical industry association, the ABPI, would like to see its own system strengthened to improve reporting of payments to health care professionals and organizations.

Europe United Kingdom

Medtech Connect Episode 9: The Intersection Of IVDs And Digital Health

In this episode, Medtech Insight regulatory reporter Hannah Daniel and managing editor Amanda Maxwell speak to Marcel Gehrung, co-founder and CEO of Cyted. Marcel discussed global regulations for Cyted’s product Endosign, and how the company leveraged the product’s flexibility to gain approval and reach markets as efficiently as possible. We also talk about different market authorization requirements in the EU, UK, and US, and the use of AI in healthcare spaces in the UK.

Digital Health Diagnostics

EU Project To Evaluate Delays To Drug Trials Conducted Alongside Studies For IVDs/Devices

The European Commission is steering a new member state-driven project that aims to get to the bottom of factors causing delays to trials that simultaneously investigate a drug product with an IVD or a medical device, and propose some solutions.

Europe Clinical Trials

EC Plans New Structures For Manufacturers Of High-Risk IVDs Soon

Among the missing elements of the EU IVD Regulation are designated reference laboratories, which are to play a key role in assessing class D IVDs. That should change by around early 2024.

Regulation EU Legislative Reform

Global Medtech Guidance Tracker: August 2023

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-three documents have been posted on the tracker since its last update.

Guidance Documents Regulation

Top Ten August: Perceived Failures Linked To MDR/IVDR Implementation Result In Fresh Calls To Action

It is no secret that that the implementation of the EU’s Medical Device and IVD Regulations has been problematic. Now, despite most processes and documents being in place, experts are making fresh warnings and calling for radical changes.  

Europe EU

UK Regulatory Update: MHRA Adds More Medtech UK Approved Body Capacity in August

The number of UK approved bodies designated to issue UKCA marking leapt from four to seven in August, adding much-needed file auditing capacity to Great Britain’s evolving medtech regulatory system. Next up: the MHRA’s consultation on accepting overseas-approved products onto the market.

United Kingdom Regulation

How Well Is The Commission Communicating On MDR And IVDR? Have Your Say!

The European Commission has launched a 16-question survey giving the overwhelmed medtech sector a chance say what MDR and IVDR information tit needs and how stakeholders want to receive it.

EU Europe

MDR Up-Classification Of Some Spinal Fusion Devices ‘Unwarranted’ Says Expert Group

A change in risk classification for some legacy spinal fusion devices under the new EU MDR means that certain products face stricter clinical evidence requirements, which expert group OSMA told Medtech Insight is “unnecessary” and “overly-burdensome” for manufacturers.

Medical Device Orthopedics

One More IVDR Notified Body In The Wings As Designation Progress Continues To Advance

Every designation of a notified body under the Medical Device and IVD Regulations has been greeted with fanfare given the historic pressure for more testing capacity. There may have been a shift in timelines, but IVD manufacturers still urgently need to engage with a certified testing body.

Europe EU

Pan-EU Health Data Sharing Platform Takes Shape

Technical teams have laid the cornerstone for the platform that will be developed to link up multiple public and private data sources and make it easier to access, integrate and analyze the vast and diverse range of data they contain.

Europe Digital Health
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