InnoScot Health to advise medical device innovators about post-market surveillance legislation
A free-to-join webinar taking place at the end of June will encourage medical device innovators to learn more about new post-market surveillance (PMS) legislation and how to successfully navigate it.
Formal NHS Scotland partner InnoScot Health will host the educational session on Wednesday 25 June from 12-12.45pm entitled ‘The new Post-Market Surveillance legislation for medical devices – what you need to know’ to present a key opportunity to better understand the changes for Great Britain.
The changes are intended to improve the safety of medical devices, including in vitro diagnostics (IVD) and active implantable devices, while providing certainty for manufacturers.
Part of wider regulatory reform, the amended regulation will, the Medicines and Healthcare products Regulatory Agency (MHRA) says, “introduce clearer and more risk-proportionate PMS requirements”.
The ‘lunch and learn’ webinar will be presented by Head of Regulatory Affairs Elaine Gemmell, who will provide an overview of the complexities of the current landscape and outline why it is vital to receive professional advice in order to navigate it successfully.
She will be joined by guest speakers from The British Standards Institution (BSI), Damon Williams, Sales Manager – Medical Devices, UK & Ireland, and Umar Butt, Business Development Manager, North UK and Ireland.
The national standards body of the United Kingdom, BSI is recognised through a Memorandum of Understanding with the UK Government, producing technical standards on a wide range of products and services.
They will speak on the similarities and key deviations the UK PMS regulation has from EU MDR/IVDR and anticipated changes.
The webinar will be a great opportunity to learn about the new UK PMS requirements for medical devices, implemented through the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 which will come into effect on June 16, 2025.
Attendees will also gain insights on ensuring Periodic Safety Update Report (PSUR) compliance for both EU and GB regulations and get updates on changes to UK MDR core regulations.
The InnoScot Health webinar series is open to all, regardless of role or organisation. All sessions are hosted online through Microsoft Teams, with joining instructions provided upon registration.
Elaine commented: “Our June webinar is an opportunity to gain a more in-depth understanding of what is crucial new legislation for medical device manufacturers.
“Never more have we needed transformative approaches to healthcare for better patient outcomes, and new medical device breakthroughs are a key driver in realising that goal.
“But clearer, more robust post-market surveillance requirements are necessary to improve safety for both patients and public alike, and in greater alignment with international standards.
“In response, we now have an important amendment this month and manufacturers are advised to learn more.
“We believe attendees will find it useful and instructive in taking practical steps.”
The webinar will be rounded off by an opportunity to ask questions of the speakers. Attendees can pre-submit queries for our panel discussion to info@innoscot.com.
InnoScot Health says the medical device industry has experienced unprecedented growth over recent years, and changes to the regulatory landscape mean it is vital innovators get the right advice, support and signposting to develop effective and innovative healthcare products.
InnoScot recently welcomed a major pan-European programme aimed at transforming healthcare through digital innovation.
