The U.K. regulatory agency has told medical device companies what to expect when the country leaves the European Union in March.
If, as expected, a 21-month Brexit transition period begins in March, companies should suffer little near-term upheaval, with CE marking and notified bodies continuing as normal. The U.K. Medicines and Healthcare products Regulatory Agency is proceeding on the basis that the deal is agreed to and the transition period will happen.
However, a no-deal Brexit could still disrupt this rosy outlook and the longer-term regulatory environment remains poorly defined.
Uncertainty has defined Brexit ever since the U.K. voted to leave the EU in 2016. That reflects a lack of clarity about the U.K.’s relationship with its neighbors after the break-up becomes official. Options proposed include a hard split that completely severs the U.K.’s ties to EU rules and institutions, a Norway-style agreement that keeps it in the European Medicines Agency and everything in between.
With seven months to go, several of those scenarios remain possible, but progress in the negotiations means one outcome is now more likely than the rest. The U.K. and EU agreed to a 21-month transition period in March. Provided the negotiators can finalize the rest of the withdrawal agreement by the end of the year, something close to the status quo will continue until the end of 2020, beyond which the situation is less clear.
In a series of documents aimed at the drug and medical device industries, the MHRA outlined how the regulatory landscape will look during the transition period.
Importantly, the MHRA expects the CE marking system that brings medical devices to market in the U.K. and EU to function as normal during the transition period. Over those 21 months, manufacturers will be able to use authorized representatives in the U.K., as opposed to needing to employ someone in the EU. Similarly, notified bodies based in the U.K. will continue to perform third-party conformity assessments that are recognized across the EU.
The view presented by the MHRA differs from that detailed by the EMA, which is operating on the basis that the U.K. will make a hard split from the EU in March. That scenario, which is still possible, would result in the U.K. being treated as a third country with no regulatory relationship with the EU. If that happens, the EU will stop recognizing U.K. authorized representatives and notified bodies.
U.K. leaders and the MHRA acknowledge this "no deal" outcome remains possible but have said little about how companies should prepare for this eventuality. The documents published by the MHRA this week feature one brief reference to the risk of a hard split.
"The government recognizes that in the unlikely scenario of no deal between the U.K. and the EU, it would be important to reach a suitable resolution to the supply chain questions that would arise," the MHRA wrote in one of its updates to the industry.
That is one of several areas in which the MHRA's advice is fuzzy. Other areas of ongoing uncertainty include the incoming EU medical device and in-vitro diagnostic (IVD) regulations. If a deal is finalized, the medical device rules will come into force during the transition period, enabling the U.K. to copy the legislation into its own laws. The IVD implementation date falls after the end of the transition period but the MHRA tried to downplay the significance of this fact.
"Elements of both new devices regulations have applied directly in U.K. law since May 2017, meaning medical devices, including IVDs, can now be legally placed on the U.K. market if they are in conformity with the new regulations, invoking all relevant requirements," the MHRA wrote.
That only partly addresses the issue, though. The U.K. can copy EU rules but it cannot guarantee it will participate in regionwide initiatives, such as the medical device database and traceability system mandated by the incoming regulations. The government wants the U.K. to be part of such initiatives but has yet to persuade the EU to allow its continued involvement.