On 21 October 2024, the UK government laid the Post-market Surveillance (PMS) Statutory Instrument in the Parliament as first major step to update the Medical Devices Regulations in Great Britain. The amendment will introduce provisions for stronger patient and public safety and aims at aligning with international approaches.
Post market surveillance requirements
The draft PMS statutory instrument was notified to the World Trade Organizaton (WTO) in July 2023. The MHRA, the UK competent authority for medical devices, provided their response to WTO with the aim to improve clarity and allow manufacturers to understand their obligations, allowing for the government to present a final draft.
The key novelties of the new proposed legislation, among other things, include:
- Details on what must be included to a PMS system, including the methods for collecting PMS data and harmonisation;
- Improved serious incident reporting obligations for manufacturers;
- Clearer obligations to consider conducting a Field Safety Corrective Action (FSCA) and detailed requirements relating to Field Safety Notices (FSN);
- Stricter requirements for manufacturers to conduct recurring reviews of their PMS data.
Timeline for future changes
The Statutory Instrument proposes a 6-months implementation timeline once the Parliament approves it. The new Regulation could come into force already in Summer 2025.
The UK MDR is currently subject to an overall revision. This year, the MHRA published a public consultation on possible amendments to the Medical Devices Regulations to include common specification requirements for IVD devices. With the consultation closing in June 2024, stakeholders can expect further updates on common specification requirements soon.
Moving towards a plastic-free future
This initiative is part of a more significant trend towards reducing plastic waste. Scotland has already implemented measures such as banning plastic-stemmed cotton buds, single-use plastic cutlery and also introduced charges for carrier bags.
Similar regulations will likely be introduced across the entire United Kingdom.
Do you have any questions on how to sell your products in the United Kingdom? Contact us today.
Simona Varrella
Regulatory Intelligence & Innovation
25/10/2024
References:
Gov.uk (2024). Statutory Instrument laid in Parliament sets out first steps in delivering Medical Device Regulatory Reform and strengthening patient safety. Retrieved on 23/10/2024.
Gov.uk (2024). Implementation of the future regulations. Retrieved on 23/10/2024.
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