Europe

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.

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.

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?

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

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.

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.

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.

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.

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.

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.

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.  

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.

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.

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.

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.

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.