An Interview With MHRA’s Outgoing Device Director: Biggest Regulatory Challenge is Software Safety
Posted 11 June 2019 | By
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.
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.
Whilst the legislation will apply from 31 October in a no deal scenario, there will be a grace period to allow time for compliance with the new registration process. Please see our guidance for further information on this.
: How does MHRA’s Brexit guidance offer flexibility to account for different scenarios? How can EU MDR/IVDR still be applied in the UK once the country departs from the EU?
Wilkinson: The Government remains focused on ensuring our smooth and orderly withdrawal from the EU with a deal as soon as possible. In this scenario full provisions have been made for the Agency to continue business as usual. To support preparations for a no deal EU exit, MHRA has published guidance that is intended to be enacted in the event of a no deal EU exit. This is applicable in a no deal scenario. Our guidance is flexible in that we have provided direction for either eventuality.
How large of an issue is the lack of designated notified bodies for MDR/IVDR moving forward?
Wilkinson: Notified body capacity is an issue regardless of outcomes and I believe that all in the system are working on the challenge of transitioning to the new Regulations, whilst not compromising on the goals that are embedded in the legislation.
MHRA has been engaging with its Notified Bodies on an ongoing basis to ensure that Notified Bodies are prepared for the designation process. Applications have been received from UK Notified Bodies, with the first joint assessment under the MDR taking place within the UK. MHRA are also providing a substantial amount of resource to Europe to support with the joint assessments of other EU Notified Bodies.
How has MHRA’s work with the International Medical Device Regulators Forum (IMDRF) helped to advance its own regulatory work?
Wilkinson: In an industry which has global scale and supply chains it is impossible for a national or even regional regulatory system to provide complete assurance for all products entering the market. So working with other regulators across the globe to harmonise approaches is essential for the continued improvement of safety of devices as well as the safety of patients and users in the UK. In order to develop these standards it is essential that leading regulators like MHRA contribute expertise. Of course, we also benefit from learning from the other regulators who are involved and that helps to ensure that we are performing to the limits of our capability.
What are some developments in the UK and EU that MHRA is looking forward to?
Wilkinson: The biggest single challenge facing regulators worldwide in my opinion is that of developing a robust and yet flexible system for ensuring the safety of software products. These will have enormous impact on the way that healthcare is delivered as well as creating a unique set of risks to be managed. Whilst at a high level these risks are similar to other products on the market, when one looks at the practical issues they are very different due to the speed of iteration and evolution of the products especially those using machine learning. In parallel with that and, of course, linked is the opportunity afforded by access to increasingly rich datasets which will inform us about the performance of products in the real word use. We see establishing new ways to utilise that data to improve outcomes for patients as central to the development of our work in future years.