Medical device and in vitro
diagnostic (IVD) manufacturers on Thursday peppered representatives from the European Commission (EC) and Ireland’s Health Products Regulatory Authority (HPRA) with questions about the upcoming deadlines, implementing acts and guidance related to the new EU device and IVD regulations.
Erik Hansson, deputy head of the EC’s Health Technology and Cosmetics Unit, offered a high-level overview of the new regulations to attendees of RAPS’ workshop
in Brussels and why they needed to be created, highlighting the building of a new EUDAMED database to strengthen surveillance, which he called “a monster,” as well as a new unique device identifier (UDI) system.
While not offering any specifics on timing, Hansson explained that as far as implementing acts, there’s a possibility of a total of 80 acts, but only “18 are mandatory.” He mentioned that the current priorities are notified bodies, the reprocessing of devices and Annex 16, which deals with devices without a medical purpose.
Hansson noted that there has been an ongoing dialogue with member states and various stakeholders, and there will be a four-week feedback period for each implementing act.
As far as upcoming guidance on the regulations, Hansson said, “What is striking is that we have a very complex piece of legislation, with a lot of text, but the cry for further guidance is as evident as ever.” In addition to new guidance coming, he also said some guidance will be considered obsolete and some will be revised.
As far as notified bodies, Hansson acknowledged the concerns raised
that some notified bodies may drop off, but he also noted that there are new ones coming in. In addition, he said Brexit is creating “lots of concern for UK notified bodies and manufacturers,” particularly because of the unknowns.
“We’ll miss all the UK contributions, but we’ll see if Brexit will happen,” Hansson said.
Niall MacAleenan, head of the medical devices department at HPRA, also presented on the Competent Authorities for Medical Devices (CAMD) road map
, offering an overview.
“Undoubtedly it’s the case that these regulations are creating pressure,” MacAleenan said. But he also backed Hansson’s contention that the new regulations are necessary to improve public health.
Manufacturers and notified body representatives in the audience grilled Hansson and MacAleenan with questions on stifling device innovation, when notified bodies will be accredited, how the EU plans to compete with the US (now that there’s a breakthrough designation for devices in the US), and who will be on the expert panels required under the new regulations.
On innovation, Hansson said that one of the purposes of the new regulations was to ensure innovation was not hampered. He also said notified bodies’ designations will depend on their preparedness and could come as early as the end of this summer, though more likely next year.
Notified bodies, meanwhile, have made clear they’re limited in what they can do until they get designated. Sophie Tabutin, notified body regulatory lead at BSI, said: “The regulators made quite clear to us they don’t have the resources to answer every question.”
As far as the expert panels under the new regulations, and questions on whether industry experts might be involved in better informing the regulators, particularly on the IVD side, Hansson said it depends on who applies and could include member state experts, others in scientific institutions from universities or consultants with sufficient medical knowledge.
“We need to look into their independence and make sure they don’t make decisions based on self-interest,” he said.
Another question offered a hypothetical of what the EC and competent authorities will do if hospitals in the Netherlands cannot allow their surgeons to use specific devices because of the new regulations.
“It’s a worst-case scenario,” Hansson said. “I hope it will not happen. These are tight deadlines.”