Device manufacturers that do business in Europe have experienced a roller coaster of emotions in the wake of “Brexit,” according to the Association for the Advancement of Medical Instrumentation (AAMI). While new draft regulations for medical and in vitro diagnostic devices provided vendors with relief, the United Kingdom’s decision to leave the European Union has left many with feelings of uncertainty, AAMI reports.
“On Brexit, I think that it is very much a wait and see,” says Eamonn Hoxey, vice president of strategic programs for the Johnson & Johnson medical device companies and a chair-elect of the AAMI board of directors. “There is a certain amount of positioning in the light of future negotiations between the UK and EU, but there is no clarity at the moment on what relationship the UK will be seeking with the EU in future.”
According to AAMI, “The situation is rich with irony?and perhaps some frustration?for manufacturers who do business in the EU. Just as years of complex negotiations on device regulations were concluding and a clearer framework was starting to emerge, a stunning national referendum introduced an entirely new dynamic.”
European lawmakers agreed just this past May on stricter requirements for notified bodies, stronger premarket scrutiny and postmarket surveillance, strengthened rules for high-risk devices, and increased transparency and traceability, AAMI points out. Draft medical device regulation (MDR) was developed to set “high standards of quality and safety for medical devices to meet common safety concerns as regards these products.” A key point of contention between the European Commission, European Parliament, and European Council had been the reprocessing of single-use devices.
Currently the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) says it remains business as usual.
“Following the result of the referendum on the UK’s membership of the European Union, the focus of the MHRA continues to be on our public health role,” the MHRA released in a statement. “Working closely with government we will consider the implications for the work of the agency. We will continue to make a major contribution globally to improving public health through the effective regulation of medicines and medical devices, underpinned by science and research.”
The British Standards Institute made similar remarks in an online statement: “BSI’s role as an EU notified body will not change following the recent decision of the E.U. referendum while the UK government sets out the arrangements for its withdrawal from the E.U. During this transition period, BSI will be working closely with the MHRA to enable BSI to continue being recognized as a notified body for medical devices. BSI fully anticipates we will remain a long term major EU medical device notified body as there are established well recognized existing mechanisms in place for non-EU countries to participate as EU notified bodies.”
AAMI reports that until Brexit is finalized, medical devices sold in the UK will continue to be subject to EU medical device laws and regulations, which will likely include the MDR. “The UK is still a member of the EU today, and the expectation is that it will implement the MDR text that it played a large part in negotiating in both the European Council and the Parliament,” Hoxey says.
To read the full statement, visit AAMI.