AAMI News February 2020
Medical Device Community Braces for Brexit
Notified Bodies and the CE Mark
The E.U. medical device market currently consists of 500,000 medical devices and IVDs—all required to have a CE Mark to be sold and purchased in E.U. member states. Manufacturers can self-certify low-risk Class 1 medical devices/Class A IVDs. For all others, manufacturers must submit the device to be reviewed by a notified body to establish that it complies with legislative requirements and earns its CE Mark.
With the United Kingdom (U.K.)’s exit from the European Union (E.U.) moving forward, the country is planning to enter an 11-month transition beginning on Jan. 31. During this time, the region will continue to follow E.U. laws until a trade agreement—which would include medical devices and in vitro medical devices (IVDs)—is drawn up or until a “no-deal” Brexit is called.
Even though the U.K. first announced its intention to leave the E.U. in 2016, medical device manufacturers and suppliers still do not have a clear picture of how this unprecedented change will affect their industry. With the U.K. exporting $2.6 billion and importing $4.3 billion in medical technologies to and from the E.U., the likely impact of Brexit is well worth considering.
European Regulatory Changes
Brexit is occurring in the same year as other large-scale regulatory changes within the E.U.—the transition from the Medical Devices Directive, the Active Implantable Medical Device Directive, and the In Vitro Diagnostic Medical Devices Directive to the European Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR).
The change is expected to bring more detailed examination of technical documentation. Notified bodies are in the process of applying for reapproval under MDR, including those based in the U.K. that would find themselves outside of the E.U. without a deal.
“What some U.K. notified bodies have done to ensure continued service for U.K. manufacturers—or anyone using a U.K. notified body—is set up European entities outside of the U.K.,” said Paul Sim, regulatory affairs manager at BSI. “For example, BSI is now operating a notified body in the Netherlands, and other U.K.-based notified bodies may follow.”
Legislative Continuity and Trade Post-Brexit
The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) published a guidance document to help stakeholders prepare for Brexit by explaining the planned legislation of medical devices.
Regardless of whether Brexit occurs with or without a deal, MHRA plans to follow U.K. MDR 2019, which will mirror key regulations in the E.U. version of MDR and IVDR when they take effect in May 2020 and May 2022, respectively.
However, the U.K. MDR 2019 places additional responsibilities on manufacturers to classify a device against new risk classification criteria and meet labeling, technical documentation, and quality management system requirements. Manufacturers will also see more requirements on postmarket surveillance.
Meanwhile, MHRA will likely continue to perform market surveillance of medical devices on the market and make decisions about the marketing and supply of devices.
Manufacturers who want to keep selling their devices in the U.K. after Brexit have a few factors to consider. If a device was approved by a U.K.-based notified body prior to Brexit, that approval will hold, but not indefinitely. Eventually, all medical devices and IVDs will need to be registered through the MHRA.
Conversely, the E.U. will eventually cease to recognize conformity assessments conducted by U.K.-based notified bodies. In addition, U.K.-based notified bodies will no longer be able to issue or maintain CE Marks. This could exacerbate an already worrisome shortage of E.U. notified bodies, as nearly 45% of all CE-Marked medical devices received conformity through the U.K. notified body.
The MHRA has advised European manufacturers to designate a U.K. Responsible Person to ensure devices remain on the market in the event of a no-deal Brexit. The U.K. Responsible Person (which can actually be an individual or group) will act on behalf of the manufacturer to supply medical devices to the U.K. after a no-deal Brexit. These Responsible Persons will need to be named before the end of the MHRA registration grace periods, ranging from four months for Class III devices to 12 months for Class I or II devices.
However, according to Sim, there is still a lot that is up in the air—including how unique the post-Brexit legislation will be.
“Some patient groups want more U.K.-specific regulations with extra requirements for medical device manufacturers to improve public health,” Sim said. “However, if we end up with more U.K.-specific regulations, U.K. manufacturers will need to start making two product lines: one that meets the U.K. regulations and one with a CE Mark. This is clearly being discussed, but nothing has been decided yet. We’re still in the very early days.”