BREXIT: UK likely to push for mutual recognition on medtech regulations, say experts

Out-Law Analysis | 12 Oct 2016 | 4:45 pm | 3 min. read

FOCUS: The UK government should seek mutual recognition from the EU for its certification of medical devices as part of its negotiated exit from the trading bloc.

Mutual recognition would be likely to depend on the UK's regulation of medical devices replicating or at least closely mirroring new EU reforms in the pipeline.

If the UK deviates too far from the EU's regulation of medical devices it would risk medical device manufacturers prioritising other markets for the launch of innovative new devices, to the detriment of patients, health bodies and the industry in the UK in general.

EU reforms on the way

Despite Brexit, the EU will continue with its plans to introduce a new Medical Devices Regulation and a new In Vitro Diagnostic Medical Devices Regulation. The legislation will not need to be transposed into national laws and instead will apply directly in EU countries.

The European Parliament and Council of Ministers reached a political agreement on the new EU legislation in June. The Council endorsed the agreement at ministers' level in September. Following their legal-linguistic review, the two draft regulations will be then adopted by the Parliament and the Council, probably at the end of the year or early 2017.

Although the new rules would technically come into force after they are published in the Official Journal of the EU (OJEU), they would, according to the latest draft, not apply until three years later in the case of the Medical Devices Regulation and five years later in the case of the In Vitro Diagnostic Medical Devices Regulation.

Whether the new legislation willtake effect in the UK will depend on whether the UK remains a member of the EU at the time the legislation takes effect.

The UK is almost certain to still be a member of the EU when the rules are published in the OJEU. The UK government has set out its intention to leave the EU in 2019. If that timetable is kept to and the EU reforms are finalised as scheduled, the UK will no longer be a member of the EU when the new EU medical device rules come into effect.

In outlining its plans for Brexit, the UK government has outlined plans to introduce a 'Great Repeal Bill'. The Bill, once given effect, will remove the 1972 European Communities Act from the UK statute book and enshrine any EU laws in effect into UK law.

When the Great Repeal Bill takes effect it could see the new EU Medical Devices Regulation and a new In Vitro Diagnostic Medical Devices Regulation written directly into UK law, at least in the short term.

CE marking

Every medical device that is intended to be put into use in the EU must obtain a CE marking. A CE marking signifies that the device meets all the requirements of EU medical devices regulation, such as on health and safety standards.

In the UK standards body the BSI, also known as the British Standards Institution, is a recognised notified body under the existing EU rules that engages in CE marking certification.

With Brexit, a Swiss-style mutual recognition arrangement on CE marking is a possible scenario. Under such an arrangement, medical device manufacturers would be able to obtain a CE marking for their product that is recognised across Europe even if they certified with the BSI.

For its part, the BSI considers that it will remain a notified body for CE marking purposes under the reformed EU medical devices regime.

In a statement the BSI said: "BSI is fully confident in continuing as the leading global provider of EU medical device notified body services by utilising established well recognised existing mechanisms for non-EU member states to fully participate as EU notified bodies. Examples are the designated organisations in Norway (under EEA recognition), Switzerland and Australia (through mutual recognition agreements) all of whom are recognised as notified bodies for the purposes of the relevant EU legislation."

"Going forward we aim to provide a seamless transition within a new designation recognition mechanism as part of any UK – EU framework/relationship once this is finally established. Our sole aim is for the transition to be effectively invisible to you our clients, leaving you unaffected from a market access perspective," the BSI said.

The UK cannot afford to close itself off from the EU market so it will most likely aim for mutual recognition.

Medical technology companies want to view Europe as a single market, not with the UK as a distinct market with separate rules and procedures for access. There is a danger that medical device manufacturers would prioritise the launch of new devices markets other than the UK if there is a major distinction between the EU and UK legal and regulatory frameworks.

Compliance with the existing and projected EU regimes should therefore be the route UK policy makers should take. Without that consistency the UK would in effect create its own trade barriers. Anything less would threaten the UK's position as a world leader in medical device innovation.

Cerys Wyn Davies and Adrian Murray are experts in the regulation of medical devices at Pinsent Masons, the law firm behind Out-Law.com.