UK – Biggest Regulatory Challenge is Software Safety

John Wilkinson, outgoing director of devices at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), answered Focus questions via email on everything from Brexit to the EU’s new medical device regulation (MDR).

In addition to offering some details on what will happen with the new 31 October Brexit deadline, Wilkinson, who is stepping down at the end of October, also discussed notified body capacity and said he believes the biggest challenge facing device regulators is ensuring the safety of software products. A lightly edited version of the Q&A is below.
Focus: What will Brexit mean for the future of regulating devices in the UK? Will there be a transition period for some devices so companies can get up to speed on any differences between EU and UK regulations?
Wilkinson: The statement, published in the Financial Times on 4 July 2017, by the Secretary of State for Health and Secretary of State for Business, Energy and Industrial Strategy laid out the three principles which will underpin the development of a post-Brexit regulatory system for medicines and devices: patients should not be disadvantaged; innovators should be able to access the UK market as quickly and simply as possible; and we will continue to play a leading role in both Europe and the world in promoting public health.
In a no deal scenario, for a time-limited period, we would continue to recognise the CE Mark on medical devices, which demonstrates their conformity with EU regulatory requirements. During this period, devices would be accepted on the UK market if they meet all EU requirements, which for all but the lowest-risk devices would include certification by EU Notified Bodies. You can read more about this in our no deal guidance here.
You may also wish to read our Statutory Instrument (SI) for Exiting The European Union (the Medical Devices Regulations 2019). This SI sets out the legal requirements for regulating devices in the UK, and companies should review these legal requirements before 31 October. The proposals have successfully passed through the Houses of Commons and Lords and have been made into law. This means that they will apply from 31 October in a no deal scenario…