Medilink North of England News 2019 Medilink NOE News 2019 | Page 3

THE PERFECT STORM – NEW MEDICAL DEVICE REGULATIONS, NOTIFIED BODY CAPACITY, AND BREXIT. The theme of our last newsletter was the new Medical Device and IVD Regulations which came into force on 25 May 2017. The transition period is therefore now well under way, with medical device companies having to comply with the new regulations no later than 26 May 2020 (less than a year away!) and 2022 for IVD companies. What has largely gone under the radar is that the time it takes to get a CE Mark audit has increased dramatically due to capacity issues and the reduced number of notified bodies. Of course, to make the ‘perfect storm’ we have BREXIT and whether we end up with a ‘DEAL’ or ‘NO DEAL’ Brexit, each with different regulatory scenarios. As you will be aware, the UK has agreed with the EU an extension to Article 50 until 31 October 2019 and the new government leadership is committed to come out of the EU by this date. What does this mean in practice? In the event of a No Deal exit, for a limited period only, companies will continue to be allowed to place products on the UK market that are in conformity with the applicable EU Directive and that carry a CE mark – certificates issued before exit day will continue to be recognised and there won’t be any changes of labelling required. A new UK regulatory system will be introduced, given that the UK’s participation in the European regulatory network will end, which will almost certainly mirror all the key elements of the EU regulations. In the event of a ‘Deal Brexit’, with an agreed withdrawal agreement, there would be a time limited implementation period providing a bridge to a future relationship between the UK and the EU, and companies would trade on the same terms as now until the end of 2020. And of course, there is a third scenario that may be becoming increasingly remote, that we do not leave the EU at all. What is clear, is that whatever the position going forward, you will need to undertake risk analysis on an ongoing basis to identify risks, impact and mitigation. If you have not already undertaken a gap analysis to understand the difference between the current MDD and new MDR e.g., the additional clinical evidence required, costs, time lines, etc., then this is something that you should prioritise. Similarly, there is a real need to make initial preparations for a Deal / No Deal Brexit. The business representatives on the three Medilink Regional Advisory Groups (North West, North East & Yorkshire & Humber) have made it clear that regulation is now the number one issue facing members. As such Medilink has recently stepped up its support in this area through: i) education / skills development: – initial conference on global regulations held on 9th July (see page 10) ii) raising the issue of the lack of capacity in Notified Bodies at a national level iii) working with Innovate UK in undertaking a survey of SME readiness for the new regulations iv) providing a voice from SME’s on what the government should be looking for in a future economic partnership around regulation, post BREXIT. Kevin Kiely Chief Executive Medilink North of England Limited MEDILINK NOE WELCOMES NEW CORPORATE PARTNER - HILL DICKINSON Medilink North of England is delighted to have teamed up with commercial law firm, Hill Dickinson, as our latest corporate partner. The three-year agreement with the law firm and its 180-strong specialist health division, provides a number of important benefits to Medilink members and the wider sector. The announcement comes as Hill Dickinson sets out its credentials as a leading provider of services to the life sciences and health tech sectors. Hill Dickinson is a leading commercial law firm that acts for more than 100 independent healthcare, pharmaceutical, life sciences, health-tech and biotech companies as well as over 100 NHS bodies. Key sector knowledge, combined with a strong corporate offering, allows them to provide an unparalleled breadth of experience and expertise across the life sciences and health tech sectors, providing clients with first class and cost-effective support on a wide range of legal transactions and matters. The Hill Dickinson team includes health tech lawyers, who offer advice in relation to medical devices and pharmaceuticals, and life sciences lawyers whose various specialisms include cell and gene therapy, reproductive and genetic technologies, embryo research, ethics and clinical trials. These experts are complemented by a team of corporate lawyers whose experience in regulatory matters and corporate finance enable them to provide a comprehensive range of sector-specific legal services. James Lawford Davies, a partner at Hill Dickinson, whose own specialisms include reproductive and genetic technologies, embryo research, and cell and gene therapies, said: ‘Our partnership with Medilink North of England is an exciting new step for us and we’re delighted to be working together with Kevin Kiely and the Medilink team. “As Medilink North of England’s recommended provider of legal services, we’re also very much looking forward to getting to know other members and supporting them in any matters related to our specialisms in health tech and life sciences.” Hill Dickinson lawyers have a real understanding, not only of the legal and commercial issues Medilink members face but also of the strategic arena and regulatory environment, policies and principles that underlie and influence the health care sector in which your business operates. To contact Hill Dickinson and find out more about how they can help your business, visit their website at hilldickinson.com 3