As part of our continuing series of educational events, Fogarty Innovation welcomed Keith Morel, Vice President of Regulatory Compliance, and Armel Plaine, Senior Clinical Project Manager/Clinical Research Regulatory Specialist, from Qserve for a presentation on changes in the regulations governing the manufacture and distribution of medical devices in Europe with the transition from MDD (Medical Device Directive, 93/42/EEC) to MDR (Medical Device Regulation, 2017/745). Qserve is the largest regulatory consultant company in the EU focused exclusively on medical devices and in-vitro diagnostics.
Regulatory Structure
Keith started by detailing the complex structure and hierarchy of EU medical device regulation, concentrating primarily on the roles of two groups, competent authorities and notified bodies.
Competent authorities are officials within the ministry of health of each country who are involved in making and implementing the laws. Notified bodies are private companies who do the “day-to-day policing of making sure that you as a manufacturer are doing the right thing,” and are involved in quality management system verification and pre-market product review.
“This means making sure your quality system meets requirements, your technical documentation is complete, and your clinical requirements are met so your device is safe and effective,” Keith explained. “For most classes of devices, a notified body will be involved somewhere in the chain. And they’re involved usually in the middle doing a conformity assessment and issuing the certificate, and also on the back-end checking to make sure you meet your post market requirements.” He noted, however, that when things go wrong, the legal requirement is to notify the competent authority(ies).
Why the Change?
According to Keith, MDR was developed to provide a consistently high level of health and safety protection for EU citizens, ensure free and fair trade of medical devices throughout the EU, and adapt to significant technological and scientific progress. “The previous set of directives were creaking at the edges,” he said, noting that newer technologies such as nano materials, tissue engineering, artificial intelligence, and software-based devices, weren’t covered fully in the directives.
Additionally, a series of public “bombshells,” including problems with metal hip implants and the PIP breast implant scandal, in which a French manufacturer used industrial grade silicone instead of more expensive medical grade silicone, fueled public outcry and demand for reform. “Politicians protested that EU medical device regulation was too permissive, and that device companies could essentially ‘test’ their products in Europe before refining them and bringing them to the US market,” he said.
Distilled down, MDR achieves the following:
- extends the scope of regulation to cover some non-medical and/or cosmetic devices (like colored contact lenses without vision correction) that had resulted in injury
- improves supervision and requires designation of notified bodies to ensure consistency and quality, and prevent manufacturers from “shopping around”
- clarifies manufacturers, importers and distributors rights and responsibilities
- provides much stronger requirements for clinical evidence
This last point is a particularly big one. It includes requiring manufacturers to integrate a post-market surveillance system into their quality management system that collects, analyzes, and reports data with a frequency determined by the device classification. “This is basically a lot more emphasis on making sure, after you have launched your product, that you have controls and processes in place to gather clinical data and make sure it is safe and performing as required,” Keith said.
Other new provisions include:
- European Database for Medical Devices (Eudamed): while reporting via Eudamed is required by the MDR, it’s not ready yet (!). Once it is ready, this database will be used to monitor the safety and performance of medical devices.
- Unique Device Identification (UDI)– this requirement, already in existence in the US, is mandatory in the EU as well, in a slightly different “more cumbersome” form. The UDI helps track devices throughout the product lifecycle.
Starting Again
One of the biggest changes is that existing approved devices are not grandfathered in. “It doesn’t matter if you were a medical device manufacturer under MDD for 30 years. You have to start again and meet all the requirements,” Keith said. The cost and complexity of this requirement is substantial, from potentially awkward scenarios like needing to acquire clinical data for devices that have been on the market for decades, to concerns around preparing required summaries of safety and clinical performance (SSCPs) for Eudamed that can be seen by patients and providers, but also competitors.
Not surprisingly, manufacturers are reducing their product offerings in the European market. “There’s about 500,000 devices certified under MDD in Europe at the moment. About 70,000 have been approved (MDR) to this point,” he said. Although there is a transition period, it is likely that many products will be discontinued. “More than 50% of respondents to a MedTech Europe survey last July said that they planned portfolio reductions,” he detailed. “All product categories will be affected, from cardiovascular to general instruments.”
Another concern is that innovation will leave Europe. “Most European manufacturers MedTech Europe surveyed are planning to launch in the US first rather than in Europe, which is frankly amazing,” he said. “When I first joined the industry 20 years ago, everyone went to Europe first because it was seen as a ‘soft touch’. Now the situation is reversed – it’s hard to get things through in Europe, while in the US it’s a mature, stable, and well-understood process.”
Still, Keith suggested that it will just be a matter of time before device makers, with the help of companies like Qserve to support them, become practiced in meeting the new requirements. “Europe is an important market, with roughly 500 million people compared to 350 million or so in the US. It’s a big market and an innovative market, and you can’t ignore it. So, while the pendulum has swung to a very strict state now, at some point it will swing back.”
Armel followed Keith’s presentation with a detailed presentation of the implications of MDR on clinical trial execution in the EU. In a nutshell, it’s much more complicated than under the MDD, but certainly important in the long term given the size of the European market.