brexit

As ABHI celebrates its 30th anniversary today, Peter Ellingworth, Chief Executive of the association discusses the past, present and future. 1. In the 30-year history of ABHI, what have been the biggest changes? Our industry has changed significantly over the last 30 years, from being simply product based, to delivering value-based service solutions and increasingly incorporating new fields of science, utilising digital data, AI and robotics. Our rebrand this year has reflected that: Association of British HealthTech Industries. We have invested in the senior leadership team, who are all contemporary industry professionals and are experts in the field of procurement, reimbursement, market access, HTA, health policy and NHS relations. We have refreshed the leadership in our regulatory and technical area and continue to build our deep relations with the MHRA and the notified bodies. Our international business has developed widely, manning the UK pavilions at global exhibitions and developing a comprehensive programme of trade missions with a strong focus on the US, and providing a programme of accelerator hubs. 2. How does ABHI engage with policymakers and legislators? The strength of ABHI’s network is one of our defining assets. We are focused at a senior level across several government departments, Parliamentarians in both Houses that are relevant to HealthTech, deep relationships with the NHS, regulators in both health and technical matters, and with the academic health science community. We represent industry on a number of high-level government forums: the Life Sciences Council, the Life Sciences Industrial Strategy Implementation Board, the EU Relationship Group, and the Health Technology Partnership. This year we formalised our relationship with a number of major cities’ health and academic communities, through a series of Memorandum of Understandings. This affords our members exceptional access to the NHS for collaboration on research, right through to adoption and spread...
W ith 45% of devices accessing the EU via UK NBs, what would be the impact of a so-called “hard Brexit?” The political landscape is far from clear. However, BSI would concur with the recent MHRA paper as we fully anticipate remaining part of the EU system for the long term. We also agree that nothing will change during the implementation period to 31 st December 2020. Netherlands – BSI Designation There is much discussion and we are very pleased to confirm BSI is almost complete in our MDD /AIMD application with a target date we are working towards agreed between BSI NL and IGJ of Q3 2018 for MDD/AIMD designation. With this in mind, if driven by a “non-negotiated” or “hard” Brexit outcome, there is a need to rapidly migrate CE certificates to the Netherlands. We have a relatively straightforward process (this does not require additional conformity assessment) agreed and the plan is resourced to deliver the change within the required timeframe. We have shared this information with our clients around the globe. If there is a non-negotiated Brexit outcome resulting in the need to migrate all certificates to the new NL NB, the advice we have received from IGJ (NL Healthcare Inspectorate), NL Ministry of Health and the EU Commission, is that a new NB number relating to our NL designation is required and it is not possible to retain our existing NB 0086 number. (BSI does however plan to retain the existing certificate number). Whilst this raises the spectrum of potentially requiring additional resources for relabelling, BSI can confirm that the relabelling requirements normally associated with transfer from other EU Notified Bodies can justifiably be prolonged (NBOG BPG 2006-01). This has been discussed with the Designating Authority in both our initial designation Joint Assessment and recent follow-up...