Quality Control & Compliance

The only step that remains now before the  European Health Data Space Regulation is approved is sign off by the Council of the EU, due next month. Industry wants to see the new framework carefully aligned with existing EU legilsation.

The IVD industry has long been awaiting a further extension of the deadlines for compliance with the IVD Regulation and for the launch date of the Eudamed database to be brought forward.

It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.

Translating research from proof of concept to clinical investigations is a difficult hurdle to overcome. To succeed, researchers need to design their technology for industrial standard manufacturing early on, Anne Vanhoestenberghe, director for the Manufacture of Active Implants and Surgical Instruments (MAISI), told Medtech Insight.

Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.

The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.

Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.

Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.

A consent decree agreed to in January between Royal Philips and the US government is now official. The decree stems from a recall in 2021 of millions of the company’s sleep therapy and breathing devices due to risks posed by the sound abatement foam inside the machines.

The EU now has a total of 45 notified bodies under the MDR.

Errors or omissions are commonplace when sponsors write their clinical investigation plans. Good signposting is urgently needed. Industry expert Maria Donawa gave some useful tips in how to best read the latest EU clinical trials guidance.

Just four devices were subject to a scientific opinion from an expert panel in the second year of reviews, compared with six in the previous year.

The EMA is extending the pilot phase of the EU’s scientific advice program and inviting a third round of applications by mid-2024.

Counterfeit copies of LifeVac Europe’s anti-choking devices have been registered on the EU’s EUDAMED database and continue to be sold on third-party platforms. Medtech Insight asked director of sales and marketing Matthew Banagan how the company deals with fake devices and what the authorities must do.

March was an important month for EU medtech regulation with an interesting spread of news relating to the Medical Device and IVD Regulations, the Batteries Regulation, the Artificial Intelligence Act and more.

The effects of phthalates, plasticizers used in many medical devices, on the human endocrine system, have long been debated. But how safe are the alternatives? Updated guidelines give more insight.