Quality Control & Compliance

In the EU, developers struggle to tell potential investors how many trials a device might require, the potential duration or associated costs. Tom Melvin explains how to tackle these issues in a third piece* based on a recent interview.

The US FDA has created a web page with answers to common questions concerning the agency’s final rule on regulating laboratory developed tests as medical devices.

The EU needs to conduct a deeper, more decisive analysis of its medtech regulatory problems before it decides how to adopt elements of MEP Peter Liese’s proposed amending regulation, regulatory expert Tom Melvin told Medtech Insight.

The US FDA has issued two new warning letters to Chinese syringe makers Jiangsu Shenli and Jiangsu Caina following inspections of their facilities. The letters are the latest in what has been an ongoing investigation into these devices.

With the axe falling on a growing number of essential legacy products, Tom Melvin explains why a plan around derogations for devices falling through the regulatory crack is now critical.

This week, Nipro Medical Corp. announced it will invest $397.8m to build a US-based production plant, generating 232 new jobs; both Baxter and Hamilton announced ventilator recalls; Imperative Care wins FDA clearance for its stroke catheter; Intelligent Ultrasound Group plc entered into a conditional sale and purchase deal to sell its Clinical AI business to GE HealthCare for £40.5m; RMI distributed 350m rapid test kits in the fight against HIV/AIDS; Jiangsu Shenli Medical Production Co., Ltd received a second FDA warning letter about quality and safety of plastic syringes.

Early and comprehensive reform of the MDR and IVDR is critical to address overregulation and unpredictable medtech regulatory processes, medtech tells reelected Commission President.

The final text of the AI Act is now available for all to read but, for medtech, it may feel that work is only just beginning.

The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks makes minor changes to its phthalates benefit-risk guidelines based on stakeholder feedback. The guidelines could be increasingly relevant given their applicability to other carcinogenic, mutagenic or reprotoxic (CMR) and endocrine-disrupting (ED) substances, lists that are bound to go on growing as the EU implements its Chemicals Strategy for Sustainability under the Green Deal.

A new reference in the document reminds the medtech sector that EU harmonized standards remain voluntary to encourage innovation.

The US Food and Drug Administration released two warning letters and two close-outs last month, with one close-out resolving a finding the Owlet Smart Sock was being sold without FDA approval.

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.