A free to join webinar taking place later this month will be encouraging medical device innovators to learn more about new Post-Market Surveillance (PMS) legislation and how to successfully navigate it.

Hosting the educational session on Wednesday 25 June entitled ‘The new Post-Market Surveillance legislation for medical devices - what you need to know’, formal NHS Scotland partner InnoScot Health believes it is 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 from 12.00-12.45 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 and Ireland, and Umar Butt, Business Development Manager, North UK and Ireland.

The national standards body for 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 medical devices regulation and IVD regulation and anticipated changes.

The webinar will be a great opportunity to:

• Learn about the new UK Post-Market Surveillance 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;
• Gain insights on ensuring Periodic Safety Update Report (PSUR) compliance for both EU and GB regulations;
• 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.

You can follow this link to register to attend.

Elaine said:

“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.

You can pre-submit your queries for our panel discussion to info@innoscot.com.

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 Health has a strong record of protecting those interests.

 

This article is written as part of a promotional agreement between InnoScot Health and Healthcare News Scotland.

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