The EU’s Artificial Intelligence (AI) Act is still in the thick of the legislative process, which seems likely to ladle even more regulatory liabilities onto AI software used for medical purposes. Bodo Wiegand, senior advisory at Viopsy, told attendees at a May 18 webinar that between the promise of yet more regulation along with existing coverage and reimbursement hurdles in the EU, developers of medical software are considering whether they should steer clear of developments that qualify as AI simply because of the extraordinary time and expense associated with generating revenues for these projects.
An increasing number of European med-tech companies are first seeking regulatory approval from the U.S. FDA because of the growing backlog and frustrations with requirements under the new regulatory framework of the EU Medical Device Regulation (MDR), which has been described as “not working.”
The recent decision by the EU to delay the implementation dates for the Medical Device Regulation (MDR) initiative is having ripple effects across the globe as other regulatory jurisdictions amend their policies to keep pace. The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) and Australia’s Therapeutic Goods Administration (TGA) have both revised their strategies to align with the latest MDR delay, giving devices that will remain available in the EU a similar extension in the U.K. and Australia.
The European Innovation Council (EIC) equity fund will no longer be managed internally by the European Commission (EC) after September. Alterdomus Management Co. SA, a Luxembourg-based fund manager, will make the final decisions on which life science companies to invest in. The aim is to optimize how the EU’s main tool for driving innovation and economic growth in Europe operates.
Early-stage venture capital firm Karista SAS reported the third edition of its European digital health funds mapping report. This mapping included all funds with global headquarters in France, Germany, Spain, Italy, the U.K., Netherlands, Austria, Luxembourg, Belgium and the Nordics.
The dominoes are falling on European clinical trials as the unintended consequences of the EU’s In Vitro Diagnostics Regulation take hold. Last year’s implementation of the regulation has resulted in the delay of up to 160 drug trials to date, with as many as 420 trials expected to be delayed over the next three years, according to an EFPIA member survey.
Device makers doing business in the EU finally have official word that the new implementation dates for the Medical Device Regulation (MDR) are in force, offering some vital breathing room for products already on the market. However, manufacturers that wish to obtain a new certificate for their legacy devices still have a lot of work to do as they must file at least a preliminary application for these devices with a notified body (NB) by May 26, 2024, not a mean feat given the crunch on notified bodies operating in the EU.
Europe has given device makers more time to meet requirements set out in the 2017 Medical Devices Regulation (MDR). The European Parliament approved in mid-February an extension of the transition periods for medical device and IVD manufacturers to comply with the new rules, which aim to enhance safety for patients and ensure the “smooth functioning of the internal market.”
The European Health Data Space (EHDS) proposal is designed to standardize practices for transmission and other sharing of health information, but this proposal is far from the only significant development coming out of Brussels.
The European Parliament (EP) has voted to affirm the proposal by the European Commission (EC) to extend the compliance timelines for the Medical Device Regulation (MDR) in an urgent vote that eliminated any chance of debate. The vote was a landslide, coming in at 564 votes in support and three nays.
