Europe

During this period of intense regulatory pressure for the medtech industry, work has been ongoing in the background to try and find a better way forward for the medtech industry, for innovation and for patients.

The AI Act is due for publication in July 2024. Marco Caproni of notified body, TÜV SÜD, explained how requirements over and above those in the MDR and IVDR impact medtech manufacturers.

After focusing on the severity of the EU’s regulatory innovation crisis, Medtech Insight now reports on discussions in Austria last month on a range of changes that could improve the outlook for cutting-edge products.

Does the difference in the height of the respective regulatory bars for innovation in the EU and US matter? And how severe are the problems being created by companies choosing to launch new products outside the EU? Hear the views of speakers at the Medtech Forum in Vienna in this first section of a two-part report from a session at the conference on innovation.

The Council of the EU and Parliament agree that fundamental changes are needed to the medtech regulations. The commission, which would have to initiate any formal proposal, has yet to publicly lay its cards on the table.

The AI medtech revolution could be a “huge, missed opportunity” for the EU without an effective and efficient regulatory infrastructure. Answers are needed fast, MedTech Europe’s Oliver Bisazza said during a recent interview.

The principles urge device makers to look at the whos, whys and whats of device use in developing their data transparency approaches.

Proposals for substantial changes to oversight of medtech notified bodies are likely to be part of the European Commission’s targeted evaluation of the MDR and IVDR, EU medtech lawyer, Erik Vollebregt, tells Medtech Insight.

A new report commissioned by trade group MedTech Europe finds that while EU medtech businesses benefit from some government support and a strong talent pool, they continue to lag in attracting investors and face mounting regulatory challenges.

Innovation has been hindered in the EU by the costs and complexities of compliance, including in the medtech sector. Bisazza looks at how high-level, multi-sectoral moves are underway to create a more innovation-friendly environment.

How Germany, which has the EU’s largest medtech manufacturing base, is pressing for the MDR to feature on the mission letter for the new European Commission and could influence the pace of change.

Despite challenges and projected European decline, the in vitro diagnostics market has enticing "pockets for growth" post-pandemic, industry leaders revealed at the MedTech Forum conference. Key drivers include healthcare decentralization and consumer pull for control over health. Opportunities exist in neurology, oncology, and direct-to-consumer testing.

MedTech Europe's Oliver Bisazza reflects on how European election outcomes may influence medtech regulatory strategy

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

Medtech Insight has already focused on six of the key changes in the parliament’s proposal to the European Commission. This article looks in further depth and breadth at the changes which, if taken up, are designed to ease the regulatory burden in the EU, support SMEs and innovation. and result in fewer products being removed from the market.

Representatives and individual experts taking part in joint assessments of new health technologies need to be free from conflicts of interest in relation to the industrial sector in which the health technology developer operates.