The extensive technical documentation requirements of the EU’s Medical Device Regulation (EU mDR) are curbing opportunities for early device development according to industry leaders.
At the Outsourcing In Clinical Trials: Medical Devices Europe 2023 meeting on February 21-22, Philips clinical project manager Deborah Ann Schuster shared some of the pain points that companies are encountering since implementation of the new rules.
In addition to time and resource constraints, Schuster said physicians and SMEs are disincentivised to begin prototype testing and trials due to the huge increases in technical documentation required by the EU MDR.
“Before the MDR was implemented, the key innovators of medical devices were able to easily set up an investigator-initiated trial,” said Schuster. “But now the requirements for the submission of technical documentation to begin these trials is way more challenging. EU MDR requires the innovators to prepare time-consuming documentation and they need much more manpower and funding to comply with the regulations.”
As most device innovation comes from startups or research groups, Schuster explained that this is having a negative impact on the large companies.
“The drivers of innovation are often the potential users, meaning physicians and physician researchers. They come up with the idea for a new device, or suggestions to improve existing devices and often those researcher physicians are the ones who develop the first prototypes. So, one of big challenges we are seeing with the MDR is in innovation of novel devices.”
To navigate these challenges, Schuster said some companies are looking for alternatives, including leveraging flexibility within different EU competent authorities.
In Slovenia, an infrastructure of CROs and trial sites is building for early development studies as the country has some flexibility compared to other.
However, other companies are looking further afield and opting to leave Europe for the US, she added.
“I assume that many companies will move to the US because prototype innovation and testing is way easier than it is here. For our Munich Philips team this is not an option because shipping outside of Europe for a second prototype will make our studies even more complex, but for other companies, it could be an option. But what we want here in Europe is to keep the innovation and keep the early development where it has been invented.”
The EU MDR and IVDR regulations became effective in May 2017 but have become applicable over a transition period, to allow time for companies to acclimate to the new requirements. In , the European Commission implemented a proposal to extend the transitional period to certify medical devices under the MDR. The proposal allows more time for manufacturers to transition from the previously applicable rules to the new requirements.
For high-risk devices, the transition period to the new rules will be shorter (extended to December 31, 2027), whereas the medium and lower risk devices will have a longer transition period (extended to December 31, 2028). The proposal also introduces a transition period for Class III implantable custom-made devices. Manufacturers will have until May 26, 2026, to certify such devices.
Supply chain, operations, outsourcing and other key topics will be discussed with industry experts and leading speakers at Arena International’s upcoming Clinical Trials events across the globe.