“On Brexit, I think that it is very much a wait and see. 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,” said Eamonn Hoxey, vice president of strategic programs for the Johnson & Johnson medical device companies and a chair-elect of the AAMI (Association for the Advancement of Medical Instrumentation) Board of Directors.
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.
It was only in late May that European lawmakers agreed on stricter requirements for notified bodies, stronger premarket scrutiny and postmarket surveillance, strengthened rules for high-risk devices, and increased transparency and traceability. Changes that the draft medical device regulation (MDR) says will set “high standards of quality and safety for medical devices to meet common safety concerns as regards these products.”
Throughout the lengthy negotiation process, one of the major points of contention between the European Commission, European Parliament, and European Council was the reprocessing of single-use devices.
Jérôme Unterhuber, spokesman for the Council of the EU, told the Regulatory Affairs Professionals Society following the publication of the draft MDR: “The Netherlands presidency of the council and the representatives of the European Parliament agreed that reprocessing and further use of such devices will only be possible where it is explicitly authorized by national law and will be subject to strict rules ensuring safety. For reprocessed single-use devices all the responsibilities of the original manufacturer go over to the reprocessor.”
The conclusion of the trialogue negotiations is a “significant step” toward finalizing legislation that “recognizes the specific nature of medical technologies, contributes to increased patient safety, and fosters the development of innovative healthcare solutions,” MedTech Europe, an alliance of European medical technology industry associations, said in a news release.
“Overall the reaction to the MDR text has been pretty positive from industry―a certain relief that the discussions are finally concluding and some clarity has emerged on the requirements,” Hoxey said.
For those who have been following the process closely there were no major surprises, Hoxey added. But just as the dust was starting to settle in medical device regulatory landscape, the U.K. voted on June 23 to leave the EU. The result of Brexit has left companies who do business in the UK wondering what the future will hold.
With Theresa May taking the reins as the next prime minister of Great Britain, the UK is expected to begin negotiations on the terms of its withdrawal from the EU soon―a process that could take up to two years.
"Brexit means Brexit, and we're going to make a success of it. There will be no attempts to remain inside the EU. No attempts to rejoin it by the back door. No second referendum. The country voted to leave the European Union, and as prime minister, I will make sure we leave the European Union," May was quoted as saying by CNN.
At the moment, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA)—the country’s medical device regulatory body—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 Medicines and Healthcare products Regulatory Agency 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 (BSI) made similar remarks in an online statement: “BSI’s role as an EU notified body will not change following the recent decision of the UK referendum while the UK government sets out the arrangements for its withdrawal from the EU. During this transition period, BSI will be working closely with the Medicines and Healthcare products Regulatory Agency (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.”
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 said.
Manufacturers, regulators, and the healthcare industry continue to watch this situation unfold very closely.