New UK PMS Regulations and Their Impact on Global Medical Device Compliance

Key Differences, Global Impacts, and Action Steps for Manufacturers

Stephen Lee, Director of Diagnostics and Digital Regulation, ABHI

Stephen Lee, Director of Diagnostics and Digital Regulation at ABHI and a leading subject matter expert on medical device regulation and compliance, recently spoke with EU MDR & IVDR Insider about the latest developments in UK post-market surveillance (PMS) regulations. 

[Download a Practical Guide to Device & IVD Post-Market Surveillance, Vigilance & Reporting]

Lee highlighted critical differences and similarities with EU regulations, outlined strategic implications for global compliance, and shared practical tips for swiftly updating processes to meet UK-specific requirements.

Similarities and Differences Between UK and EU PMS Regulations

Lee began by noting the substantial alignment between UK and EU PMS regulations. "There's a lot of alignment," he explained. 

"Many of the requirements are exactly the same. It's important to acknowledge the similarities." 

Differences do exist, Lee clarified, but many are minor and typically involve variations in wording rather than substantive procedural changes.

Global Implications for Manufacturers

A significant point Lee raised was the broader impact of these regulations on companies operating internationally. 

"The idea is you might need a dual compliance strategy," he said, referring to the regulatory nuances between Northern Ireland and Great Britain. 

However, Lee reassured manufacturers that no radical changes are expected. "People might need to adapt their existing strategy, but there are no radical changes needed. Overall, your EU strategy should work rather well."

Lee emphasized that robust post-market surveillance systems facilitate regulatory recognition and reliance among trusted jurisdictions, including the FDA, TGA, and Health Canada. 

"Having a robust post-market surveillance system makes recognition and reliance on other trusted jurisdictions more achievable," he said. 

This approach not only ensures compliance but also fosters trust and improved dialogue between industry and regulators.

Five Practical Steps to Swiftly Update PMS Processes

Lee provided five actionable steps companies should follow to promptly align with the updated UK PMS regulations:

1. Engage actively with the MHRA consultation process. Lee stressed that manufacturers should provide feedback on guidance documents. "Make sure the company actively provides feedback on MHRA guidance documents," he advised.
2. Review existing regulatory strategies. Assess if updates are needed, particularly around documentation. "Check your documentation is up to date and make sure you can meet all new UK requirements," Lee recommended.
3. Understand new definitions and terminology. Lee pointed out changes in definitions such as "device lifetime" and "serious public health concern," highlighting the importance of understanding how these definitions influence reporting criteria.
4. Prepare for potential differences in data collection expectations. The UK may require more historical data or comparative data from devices outside the UK market. "That might be something you need to build into your system," Lee said.
5. Maintain agility amid evolving guidance. Lee emphasized that the UK regulatory environment remains fluid, with updates expected. "Stay agile and make sure you can make those decisions when you need to make them," he concluded.

Lee's insights provided clarity on the nuanced relationship between UK and EU regulations and underscored the practical steps manufacturers must take to maintain compliance. 

As the regulatory landscape evolves, Lee's recommendations offer a clear roadmap for navigating PMS obligations effectively.

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Stephen Lee, Director of Diagnostics and Digital Regulation at ABHI and a leading subject matter expert on medical device regulation and compliance, recently spoke with EU MDR & IVDR Insider about the latest developments in UK post-market surveillance (PMS) regulations.