AAMI News February 2019
Potential ‘No-Deal’ Brexit Threatens Device Industry
Time is running out for the United Kingdom to broker a deal for its exit from the European Union.
With the United Kingdom (U.K.) fast approaching its March 29 deadline for leaving the European Union (E.U.), and the looming possibility of a “no-deal” Brexit, medical device manufacturers have been left wondering what lies ahead.
“The situation regarding Brexit is unprecedented and unpredictable,” said AAMI Board Chair Eamonn Hoxey, an international quality and regulatory compliance consultant. “Manufacturers using the U.K. as a route to place medical devices on the E.U. market or placing devices on the U.K. market need to have contingency plans in the event that the U.K. leaves the E.U. without an agreement.”
In mid-January, the U.K. Parliament rejected a deal for Britain’s exit from the E.U. by an unprecedented margin of 432 to 202. The plan aimed to facilitate an orderly departure and set up a 21-month transition period to negotiate a free trade deal.
Without a deal, there would be an abrupt end to the single-market relationship between the U.K. and the E.U., which could trigger delays of up to six months for medical devices at the E.U. border in one “worst case scenario” described by the U.K.’s Department of Health & Social Care.
Following the vote on Jan. 15, Jean-Claude Juncker, president of the E.U. Commission, released a statement saying: “The risk of a disorderly withdrawal of the United Kingdom has increased … While we do not want this to happen, the European Commission will continue its contingency work to help ensure the E.U. is fully prepared.”
Disrupting the Market
To be sold in the E.U., medical devices must be issued a CE marking to indicate compliance with applicable legislation. CE stands for the French phrase “conformité Européene.” Higher-risk devices must be certified by an independent conformity assessment body, known as a notified body, that is designated and overseen by their national authority (the Medicines and Healthcare products Regulatory Agency [MHRA] in the U.K.), following joint audits by two other national authorities and the European Commission.
Last fall, the British government published a series of documents outlining the consequences of a no-deal Brexit on businesses in the European Economic Area, including the medical device industry.
According to the Department of Health & Social Care, if there is no deal after March 29, “the U.K. will recognize medical devices approved for the E.U. market and CE-marked” for the near future. However, the MHRA would no longer be authorized to supervise U.K.-based notified bodies, which “implies that their certificates will become void immediately after Brexit takes effect, having a serious impact on the availability of medical devices in the E.U. as well as the U.K.,” according to the global medical device consulting firm EMERGO.
Regardless of the outcome of a Brexit deal, the U.K. intends to comply with “all key elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulations (IVDR),” according to the Department of Health & Social Care.
The MDR gives medical device manufacturers until May 2020 to meet all of its requirements, which include:
- Unique device identification implementation.
- Increased postmarket surveillance, including unannounced audits.
- More rigorous clinical evidence for higher-risk Class III and implantable medical devices.
A panel of international experts will discuss the implications of Brexit and MDR implementation during the International Conference on Medical Device Standards and Regulations, April 24–25 in Reston, VA. See related story.