The final texts of the new European medical device and in vitro diagnostic (IVD) regulations were published on Friday in the Official Journal of the European Union, setting in motion the timeline for implementation of the new regulations to commence on 25 May.
Gert Bos, executive director at Qserve Group and a RAPS board member, explained to attendees of the MedCon conference in Cincinnati on Thursday some of the difficulties that industries will face over the next three years for device manufacturers and five years for IVD manufacturers.
He stressed the need for companies large and small to read the final texts and begin their transition processes as soon as possible.
One of the main questions for high-risk device manufacturers, he said, is whether they will have enough clinical evidence to keep their devices on the market, as currently about 95% of such devices authorized in the EU still rely on data from competitors.
Bos also noted that companies should keep their eye on any implementing or delegated acts released over the next few years, as these will help companies implement the texts and work through the practicalities of what to do.
He also suggested that companies figure out if their notified bodies are ready to comply with the new regulations, noting it may help to engage with these companies on a regular basis to discuss processes and timelines.
Philippe Auclair, senior director of regulatory strategy and advocacy at Abbott Laboratories, also explained that if a company has claimed equivalence with a third party manufacturer, it will have to have a contract with that company to allow future use of that data, and will need to monitor that data on an ongoing basis.
Last month, a leading notified body found that two-thirds of products currently on the EU market have gone through equivalence route without using their own data, and moving forward, all of these products will have to provide evidence, he said.
And if a device or IVD manufacturer is using a UK-based notified body, Auclair told attendees to make sure there is a back-up plan to either establish an entity in the EU when Brexit occurs, or to partner or work with a partner in the EU.
Official Journal of the European Union