New UK Post-Market Surveillance (PMS) Rules for Medical Devices
The UK's medical device industry is undergoing a transformation with the impending introduction of new post-market surveillance (PMS) rules. These regulations, outlined in the UK PMS Regulation, are set to become law in December 2023 and will apply to medical devices entering the Great Britain market from July 2024. In this blog post, we'll take a deep dive into these rules and explore how AF Pharma can assist you as your UK Regulatory Partner (UKRP).
Similar to the EU Medical Device Regulation 2017/745 (EU MDR) and the In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR), the UK PMS Regulation mirrors many aspects of these EU regulations. However, there are some intriguing differences worth noting, especially as you prepare your UK MDR-compliant PMS plans for devices slated for the Great Britain market.
Retention of PMS-related documentation:
Under the EU MDR and IVDR, manufacturers must retain technical documentation for 10 or 15 years, depending on the device type. The UK PMS Regulation introduces a unique concept—the 'lifespan of the device,' which extends the retention period beyond 10 or 15 years. This requires manufacturers to consider factors like the device's shelf life, expected performance duration, and foreseeable usage.
AF Pharma's expertise as a UKRP can guide you in determining and documenting the device's lifespan effectively, addressing data protection concerns and aligning with the UK PMS Regulation.
2. Reporting of field safety corrective action (FSCA) abroad:
While the EU MDR and IVDR only require reporting of FSCA conducted outside the EU if it affects EU-placed devices, the UK PMS Regulation takes a more cautious approach. Manufacturers must notify the MHRA about FSCA conducted abroad for devices placed on the Great Britain market and explain why this action doesn't apply to devices within Great Britain.
AF Pharma can help streamline your reporting process and ensure compliance with the UK PMS Regulation.
3. PMS for devices under exceptional use authorization:
The UK MDR introduces "exceptional use authorization" for devices that haven't undergone conformity assessment. While the UK PMS Regulation excludes these devices from PMS obligations, it's likely the MHRA will still require some form of monitoring and reporting.
AF Pharma's regulatory expertise can assist you in navigating the requirements for devices under exceptional use authorization.
4. PMS for CE Marked devices:
Great Britain continues to recognize CE Marks affixed to medical devices following EU conformity assessment. However, the UK PMS Regulation clarifies that data from the UK PMS system isn't mandatory for updating processes and documentation for CE Marked devices.
AF Pharma can guide you in managing the nuances between UK and EU PMS systems, ensuring seamless compliance, as UKRP and EU authorized representative.
5. More detailed provisions:
Beyond these key differences, the UK PMS Regulation includes some technical distinctions that manufacturers should consider when crafting PMS plans for Great Britain.
AF Pharma's meticulous approach can help you navigate the intricacies of the UK PMS Regulation and stay ahead of compliance requirements as UKRP.
In conclusion, understanding the UK PMS Regulation is essential for medical device manufacturers. AF Pharma is your trusted partner, ready to assist you in complying with these regulations, tailoring your PMS plans, and ensuring a smooth transition into this new regulatory landscape. Contact us today to learn more about how we can support your journey in the UK market.