This change – introduced through the Medical Devices (Post-market Surveillance Requirements) (Amendment) Regulations 2024 – is more than just a regulatory update. It’s a call to action for manufacturers to adopt a proactive, data-driven approach to compliance, safety and innovation.

These changes aim to enhance patient safety, increase transparency and align UK standards more closely with global best practices.

Key pressures here include:

• Increased compliance overhead: The need for detailed PMS Plans and periodic reports for all devices requires dedicated resources and expertise.
• Need for robust data infrastructure: Tracking device performance in real time requires more than spreadsheets; it demands a secure and scalable data infrastructure.
• Pressure to align with UK-specific reporting: While the new UK rules are similar to the EU MDR, they’re not identical. One key difference lies in the scope of reporting; EU MDR requires broader market intelligence, including safety data from similar devices by other manufacturers and consideration of the evolving technological landscape. 

In contrast, the UK PMS framework focuses more narrowly on device-specific data from the GB market, and does not mandate inclusion of competitor data or external benchmarks. This divergence prevents a simple "copy and paste" of compliance strategies and calls instead for a modular PMS approach – one that supports deeper reporting in EU submissions and streamlined processes for UKCA-marked devices. The push for real-world evidence is a global trend, with other major regulators like the US FDA also mandating robust post-market data collection for many devices.

However, these challenges also create opportunities. For companies that embed a proactive and efficient compliance strategy into their innovation lifecycle, these regulations can become a source of competitive advantage.

It's also critical to note that these changes are a sign of what’s to come, with future UK regulations expected for areas like software/AI and Unique Device Identification (UDI).

At Zühlke, we understand that compliance is not just a checkbox. When done right, it’s a competitive advantage. With deep expertise in regulated industries like HealthTech, we help organisations navigate the highly-specific challenges posed by an ever-evolving regulatory landscape.

Health industry leaders already recognise that technology is critical when it comes to compliance, with 70% reporting that it provides better visibility of risks and 51% confirming it enables a faster response to issues.

We help organisations:

• Design and implement PMS-ready systems that automate data collection and reporting – ensuring they are integrated directly into your Quality Management System, as expected by approved bodies.
• Integrate AI-driven monitoring tools to detect safety signals and trends early.
• Build digital platforms that are secure, scalable and compliant with MHRA and international standards.
• Navigate regulatory complexity with multidisciplinary teams that combine engineering, strategy and emergent technology skills that modern compliance demands.

In addition, Zühlke helps companies streamline PSUR reporting workflows (as required under Reg. 44ZM), detect safety trends early through AI-supported analysis (Reg. 44ZN) and ensure readiness through regulatory gap assessments aligned with both UK MDR (Reg. 44ZE) and ISO 13485.

For manufacturers developing software or AI-based medical technologies, we also support digital health compliance in line with IEC 62304 – anticipating future guidance for SaMD and AI/ML systems in the UK.

So, whether you're launching a new device or modernising legacy systems, Zühlke offers end-to-end support – from concept to compliance and beyond.