New Medical Device Regulations Take Effect in Europe
The rules usher in beneficial and progressive changes, but challenges to implementation remain, Alan Fraser says.
Completing a process started about 13 years ago, new rules for how medical devices are evaluated and brought to market in the European Union (EU) came into full force last Wednesday—with implications for everything from contact lenses to implantable cardiovascular devices.
In broad strokes, the updated Medical Devices Regulation (MDR) aims to enhance the quality and safety of medical devices by tightening up how they’re evaluated and certified ahead of market introduction; make the data used for approvals more transparent; improve postmarketing surveillance; and reduce administrative burdens on manufacturers.
“The legislation will strengthen innovation and our international competitiveness, ensuring that we are ready for any new and emerging challenges,” Stella Kyriakides, European Commissioner for Health and Food Safety, said in a press release announcing that the rules took effect.
The European Commission first initiated discussions around changing regulations for medical devices in 2008, according to Alan Fraser, MBChB (Cardiff University, Wales), past chair of the regulatory affairs committee of the European Society of Cardiology (ESC). Proposals and negotiations among relevant stakeholders—including the ESC—resulted in a major agreement between the European Council and the European Parliament in 2016. The European Parliament then passed the law in 2017, with a 3-year transition period for implementation; the pandemic delayed that by a year.
The cardiovascular community is especially impacted by any changes to how devices are brought to market because such a large proportion of the highest-risk (class III) medical devices have CV indications, Fraser told TCTMD. “We know that cardiovascular devices are 50% or more of the proportion of all high-risk medical devices, so it’s extremely important that we engage as a community,” he said. The ESC has released resources to help the cardiology community understand how the new regulations will affect daily practice—those include an April 2020 webinar and a June 2020 paper in the European Heart Journal. Fraser also discusses the MDR in a podcast on the ESC website.
Among the updates to the regulations, there will be a new premarket mechanism by which high-risk medical devices are scrutinized by a pool of experts at the EU level, as well as stricter rules governing how notified bodies—independent third-party organizations approved by national regulators to certify medium- and high-risk devices—perform their conformity assessments. All will be required to have unique device identifiers to allow traceability, and a database called EUDAMED will make information used to support device approvals, including a summary of the safety and efficacy data for all implantable and high-risk medical devices, available to the public for the first time. Patients who receive implanted medical devices will now also receive an “implant card” with relevant information. Regarding what happens after approval, postmarketing surveillance requirements have been strengthened and mechanisms for coordination across countries have been enhanced.
The ESC welcomed the new regulations in a press release, saying they “will bring many improvements to the medical devices system that the ESC has advocated, such as: greater involvement of clinicians, scientists, and engineers in the scrutiny of evidence for medical device certifications; stronger safety requirements for high-risk medical devices and postmarket surveillance; and access to safety and clinical performance data for new devices.”
The major aspects that are “beneficial and progressive,” according to Fraser, are the increased requirements for clinical evidence supporting high-risk devices before they gain market access, the greater transparency about what evidence is being vetted by notified bodies, and the involvement of expert panels in reviewing evidence. These are important steps forward, he said, “because one of the major criticisms with the European system was that it was not transparent and that the clinical standards may have been lax. But certainly they were probably variable, because we didn’t know how they were being applied by different notified bodies.”
The ESC still has concerns about whether adequate resources were available to implement the MDR, citing in the press release an insufficient number of notified bodies to handle certification requests from manufacturers, the fact that EUDAMED is not fully operational, and uncertainties around the procedures for high-risk devices.
Fraser pointed out that an impact assessment for the legislation indicated 50 full-time employees at the EU level would be required to manage implementation of the MDR, but only about 10 are dedicated to regulation of medical devices within the European Commission’s Directorate-General for Health and Food Safety (DG SANTE). That compares with about 3,000 people working on device certification within the notified bodies across Europe and the 900 people tasked with regulating medications at the European Medicines Agency (EMA).
To help address some of the unknowns about vetting high-risk medical devices, Fraser is heading up a 3-year project called CORE-MD, which got underway in April. The effort will involve a consortium made up of representatives from academia, medical societies, regulators, notified bodies, patient associations, and industry that will review the methods for evaluating high-risk medical devices. Manufacturers of devices used in percutaneous structural heart interventions, for instance, can benefit from external perspectives on which devices are likely to work, on the design of early trials, and risk management, Fraser noted.
Nevertheless, it’s not clear what the first few years under the new rules will bring. “There are remaining questions on various fronts, and I would guess this process will continue indefinitely,” Fraser said, noting that the legislation mandates a report after 5 years to provide the European Parliament with an update on how things are working. “So I think it’s now at a stage where it’s very important that it operates and that we see how it works, and [know] that if there are issues that arise then there will be the opportunity to review them and to consider the process again in a few years’ time,” Fraser said.
MedTech Europe, which represents the medical technology industry, also welcomed the changes. But it, too, highlighted some challenges, including a “nonharmonized” interpretation and application of the rules across Europe, limited capacity among the notified bodies responsible for certifying devices, and problems with agreements between the EU and specific countries, like Switzerland.
Add to that the fact that the United Kingdom is no longer included in the MDR framework after Brexit, Fraser said. “I see those as unfortunate developments when we should all be working together even more closely, across the Atlantic as well as all over Europe.”
During the negotiations around the MDR, it was decided that there would not be an attempt to develop an EU-level device regulator, like the EMA for pharmaceuticals, which hampers that type of collaboration. Fraser said he thinks it would still make sense to pursue that avenue, however.
“It’s very difficult for the [US Food and Drug Administration], for example, to know whom they can speak to in Europe for detailed questions on individual types of devices, because the corresponding in-house specialist clinical experts don’t exist at the European level,” he explained. “They’re in national member states, regulatory agencies, and the people who do the individual assessments of evidence are in the notified bodies.”
Having an EU-level agency might help ease concerns about innovation, too, Fraser indicated. He noted that there is some perception that North America is becoming a more-favorable environment for early evaluation of innovative technologies, and that could be related to the fact that it is possible to have early discussions with the FDA about evidence requirements in the US, something that is difficult in Europe. “In Europe, we think that global regulatory convergence should be higher on the agenda and much more actively pursued,” he said. “I think everyone agrees in principal, but the progress is probably slow.”
Something else to watch out for, according to Fraser, is the implementation date of May 2022 for the new regulations for in vitro diagnostic devices. Fraser said capacity concerns are even more of a concern for that realm than for the MDR because the new rules will require a much greater proportion of in vitro diagnostic devices to undergo conformity assessments by notified bodies than in the past.