On Friday 1st November, SEHTA hosted their 2024 International MedTech Expo & Conference at the Hilton London Tower Bridge Hotel. As always, it was a great opportunity to meet fellow industry professionals and to listen to all the latest developments in the MedTech and digital health sector.
We listened to an insightful presentation on "How tech will help the NHS", followed by useful advice on "How we can support the MedTech SME". There was also an opportunity for SMEs to gain a better understanding of public sector funding and investor funding, from an excellent talk by Professor Mike Lewis at NIHR and Esther Reynal de St Michel Richardot from THENA Capital.
Our very own Robin Stephens, gave an excellent MedTech regulatory update, covering
MHRA increasing registration fees (to support PMS activities)
EU MDR updates such as the European Parliament resolution 23 October 2024 calling for an urgent revision of MDR. The resolution particularly focused on concerns around:
Impact on Patient Care
Harmonisation and Simplification
Innovative Products
SME Support
EUDAMED Database
Regulatory Flexibility
The European Commission has been asked to propose solutions by Q1 2025 – watch this space.
Our Senior Clinical Associate, Clare Barclay, followed with a very helpful piece on the need for Clinical Evidence and the latest insights on submissions for clinical studies. Clare covered everything from clinical data requirements, clinical investigations and MHRA submissions to common deficiencies; research ethics committee requirements and the new inclusion and diversity plan, which the HRA are working on with MHRA. Some useful links are:
Robin and Clare certainly drew in a large crowd and received very positive feedback from the attendees.
All in all, the conference provided a good opportunity to network, to make new connections and for us to get to know our MedTech community a bit better.
For any MedTech regulatory or clinical advice, please contact us at info@psephos.com