With the EU Medical Device Regulation (MDR) having finally come into force on May 25, developers of high-risk implantable devices now find themselves having to navigate a more complex regulatory landscape. Companies in the growing field of neuromodulation technologies – such as those attending the International Neuromodulation Society (INS) congress taking place in Edinburgh, Scotland, this week – fall in this high-risk device category – as they transition from the Active Implantable Medical Device Directive 90/385/EEC to the MDR, they will undoubtedly encounter changes in the regulatory path towards achieving CE mark for their products.
"The volume is significant for implantable devices," Halliday says. "But we are recruiting and training."
This will present some challenges, acknowledged Suzanne Halliday, head of medical devices at the notified body BSI Group. In an interview with Medtech Insight at the INS Congress' Innovations Day on May 28, she said that one of the key concerns companies will have with the new regulation relates to clinical data.
Clinical Data Conundrums
"I guess the biggest question is how much clinical data is enough," Halliday noted. "At the moment, we are following MEDDEV 2.7.1 Rev 4 and, in the future, we'll be following the MDR, and the words are that there needs to be sufficient clinical data and the data will have to be scientifically robust and have validity. BSI uses its own technical teams – we have our own in-house clinicians and we also work with external clinicians and statisticians – to help make a decision on whether companies do have enough data." (Also see "Companies Fear EU Clinical Evaluation Guidance Document Is Becoming De Facto Law" - Medtech Insight, 14 Oct, 2016.)
While there are fears that the MDR will make Europe a more difficult market to access for device companies, Halliday believes that "if there is good evidence and there is real safety and performance data on the device, then no regulatory body will turn it down – the product will get to market, in any country," she said.
Another big question that BSI often encounters from companies is how they can successfully transition toward compliance with the regulation's new processes and procedures. Here, Halliday emphasizes the need for companies with devices currently on the market to start collecting good post-market clinical follow-up (PMCF) on those products. "Then, when you make a small change to that device, that PMCF data will count towards supporting that small change and getting it approved and into the market, even under the new regulation," Halliday advised. "When there are big changes made to the devices, those are the times when there will have to be a new clinical investigation."
Halliday added that companies must not tarry in gathering that PMCF data. "Do it now because it will really help you. The EU regulation entered into force on May 25 and BSI now gets to apply for designation to be a notified body in six months. It may take us 18 months to two years to get designation because the process described in the MDR is very extensive, so that means the manufacturers have about 18 months to 2 years before they can transition towards the regulation. Good data on their devices, which show the safety and the performance, will help them."
Notified Body Challenges
The new regulatory era in Europe will mean a heavier workload for notified bodies like BSI. Coping with the increased volume of devices is one of the organization's key priorities right now.
"The regulation will bring some new devices [into the scope of regulatory bodies], up-classify some devices and change the route of conformity for some devices," said Halliday. "For the first time ever, notified bodies have to issue the product-specific technical documentation certificates for all implants, even if they are class IIb implantable devices," said Halliday. She estimates that BSI could end up with twice as many certificates as it currently does after transitioning all the products that are on quality-management-systems certificates to the MDR's technical-documentation certificates, on top of the forthcoming class IIb devices that its manufacturer clients intend to put out into the European market.
"So the volume is significant for implantable devices. But we are recruiting and training ... and our whole team gets together in June for one week ... to get their initial training in assessing to the new regulations," Halliday told Medtech Insight. This training includes practice assessments under the MDR requirements, which will then be used in the notified body's application to be re-designated.
While both manufacturers and notified bodies may very well encounter some bumps along this new regulatory journey, Halliday believes that more collaboration between different stakeholders will help smooth the ride.
"I came to [the INS congress] because ... even though notified bodies have medical doctors in house, we often need real experts in particular areas. At conferences like these, we meet medical doctors who aren't working for the manufacturers directly so they can be considered impartial and they can help us make good, safe decisions. We want to make safe decisions and we want to go as quickly as we can. That's a good way of bringing it all together."