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External Affairs Working Party Meeting – 17 September

By September 17, 2021September 23rd, 2021No Comments

The BIVDA External Affairs Working Party held its latest meeting, following a break in August, on Friday 17th September.

On the agenda were updates from Doris-Ann Williams and Helen Dent on BIVDA’s latest activities and upcoming programmes, with no external speaker this meeting.

Doris-Ann addressed the launch of the future medical devices Consultation by MHRA, saying that BIVDA received advance warning of its release, there are 10 weeks left until response deadline. BIVDA is working on an industry response to be led by the Regulatory Affairs Working party sub-group on UKCA marking.

On a further note to Consultations, at least one more webinar will be held on the laboratory evaluation Consultation on COVID-19 Antigen & Molecular test laboratory validation testing. This is to be held by BIVDA and ABHI jointly.

Regarding the Diagnostics Strategy, there is a strong emphasis on IVDs coming out through the discussions. There have been three workshops hosted by BIVDA, MediLinks and ABHI on different aspects. BIVDA hosted the webinar on ‘Access and Adoption by the NHS’. Next week, there is a roundtable on the Strategy on Thursday, which Doris-Ann will be attending. The Strategy is not a policy document itself, but a gathering of information to push a funding bid into the Comprehensive Spending Review to secure investment in diagnostics.

AMR, Long COVID and Sepsis are being rolled into one type of issue, as Long COVID has a lot of similarity with post-Sepsis conditions.

Regarding the Blood Collection Tube issue, BIVDA is reassured by BD that it is ‘business as usual’ now. It was a combination of issues that led to the problem, and certain lessons on Procurement arrangements are to be taken from the supply issues.

BIVDA is proposing to join the Royal College of Radiologists and the Royal College of Pathologists’ steering group on a new APPG for Diagnostics. This will be a positive step, with industry supporting the professions to raise awareness of the importance of diagnostics.

Helen talked the Working Party through Public Programmes important to BIVDA, including NHS Net Zero, NICE Methods and Process Review, GIRFT (Scan4Safety), MedTech Funding Mandate, Credentialing, EU Exit. She also presented on the Strategic Pillars from September to December. These cover market access, external affairs, membership and the organisation. BIVDA is currently recruiting a new Policy Officer and Regulatory Affairs Manager, as well completing a PR project, working towards COP26 and there remain two Policy Papers to be completed and released.

The next External Affairs Working Party meeting date will be announced shortly, with an Eventbrite page for registrations made available.