Quality Control & Compliance

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.

A new FDA lab-developed test compliance guide for small enterprises summarizes agency policy but fails to address clinical lab industry concerns about the LDT final rule.

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 US FDA has issued its final guidance defining manufacturer behaviors it deems as hampering the agency’s ability to conduct an inspection. In a previous draft guidance, the agency expanded its longstanding policy on inspections of drug companies to include device makers as well.

Cutting edge technology could significantly enhance operating room efficiency, according to a new report from Medtronic. The problem, however, is that most ORs don’t have it.

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.

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 round of tariffs imposed by the Biden administration on various Chinese goods, including medical devices, points to a broader shift in US strategy for strengthening supply chains and ensuring Americans have reliable access to safe products, according to analysts who spoke to Medtech Insight about the tariffs. While fueled by the pandemic, the momentum pushing this change in trade policy has been growing for some time.

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.

The US FDA has issued a final rule allowing the agency to destroy some medical devices that have been refused entry into the US. The rule takes effect 1 July.

The US Food and Drug Administration's upcoming switch from the familiar Quality Systems Regulation (QSR) to the new Quality Management System Regulation (QMSR) is enough to strike fear into the heart of many a device maker. But the rollout may prove smoother than some have warned, consultants Steve Silverman and Eric Henry say. Find out what's to come in this Medtech Insight exclusive.

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