Activity Update from the Chief Executive

During February there was a wide variety of external engagement meetings with stakeholders. BIVDA was invited to speak at two Westminster Health Forum meetings, on NICE and on Antimicrobial Resistance.  

Doris-Ann attended the Accelerated Access Collaborative (AAC) Steering Group meeting in preparation for the AAC Board meeting on Wednesday this week (4th March) where BIVDA has representation from Executive Board member Richard Hames (Werfen). There workstreams of the AAC are progessing with a developer now appointed to produce the Innovation Portal, a central team in place to deliver streamlined horizon scanning. The MedTech Funding mandate will be published during March  along with the Tariff 2020/21 ready to come into effect from 1st April. This is, on the face of it, disappointing to industry but it is the start of a new policy and will evolve over time. The next rapid uptake products will also be agreed this week. The AAC does have a new website so worth taking a look.

Doris-Ann has also participated in a costings workshop organised by NICE to develop generic templates for companies to use to produce costings for products under going assessment which will help NICE committees assess products and should help products get through the process as currently companies produce a wide variety of information.
A briefing was held at BEIS for the medtech sector to start preparations for negotiations with the EU and how the process will work. Negotiations started this week and the OLS will be in touch with us regarding the sort of evidence they will need to support the regulatory discussions. The Prime Minister announced at the end of January that the UK would not be using EU regulation so the OLS are working with MHRA to ensure UK medtech regulations remain close enough to allow mutual recognition of conformity ie if you meet the UK regulatory requirements then you won’t need to CE mark for the EU and vice versa. We will keep you posted on that but any information members can provide, such as estimated cost to having a separate UK system without mutual recognition, would be invaluable.

 A key meeting was also held in Cardiff with the Head of Procurement for NHS Wales, Jonathan Irvine to outline BIVDA’s concerns about KPIs in tenders and also to highlight the issue of credentialing. Another meeting  will be held next week with NHS Scotland.

Doris-Ann went to MedTech Europe for the National Association meeting where discussion was focussed around regulation and the work that is being done on the value of diagnostics. The issue of in-house testing has become significant in a number of EU states, especially Belgium and the Netherlands where the end users are preparing legal challenges to the IVD Regulation concerning in-house tests.

Speaking of regulation, BIVDA held a seminar for economic operators at the end of February as the requirements under the IVD Regulation for distributors and importers are not well known or understood. This was fully subscribed and BIVDA can arrange another if there is demand.

Doris-Ann also attended a meeting hosted by the Dept of Primary Care in Oxford to discuss the value proposition for AMR tests in primary care. Without any primary care commissioners it was difficult to get beyond the health economics but it was agreed that this is an area that needs further focus and a value ascribed to the potential loss of antibiotics to healthcare in the future.

Coronavirus news -  MedTech Europe are working on the introduction of commercial tests using the emergency derogation procedure under the IVD Directive. If any members do have tests available then MHRA are handling the derogation for the Secretary of State for Health & Social Care who is the named person responsible for the derogation in the UK.


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