Are You Ready for the New Era of Medical Device Compliance?

Why UK Health & Social Care Providers Must Take Action Now

The UK’s medical device regulatory framework has undergone its first major overhaul since Brexit, with new rules coming into force from 16 June 2025. While the changes may seem targeted at manufacturers, the implications for health and social care providers— including GP practices, community clinics, and care homes—are significant.

As a trusted consultancy partner to many care providers, Swift Management Services is here to ensure you’re not caught off guard.

🔍 What’s Changed?

The Medicines and Healthcare products Regulatory Agency (MHRA) has introduced stricter post-market surveillance (PMS) requirements for medical devices used in Great Britain. This includes:

• Clearer accountability for reporting device malfunctions, near misses, or adverse events
• Mandatory documentation on the safe use and storage of all medical devices
• More detailed logs and tracking of who used what, when, and how
• Periodic reviews of whether devices are still appropriate for use (especially in long-term care settings)

⚠️ Why It Matters to Care Providers

While these regulations primarily affect manufacturers and importers, registered providers are accountable for device use and safety on-site. This means:

• Using a defective or expired device—like a nebuliser, blood glucose monitor, or hoist—could expose you to legal or regulatory action
• The CQC and local commissioners may now probe how you ensure ongoing compliance with MHRA guidance
• Improper logging of device use or failure to act on faults could be considered a breach of Regulation 12 (Safe Care and Treatment)

🧠 Are You Compliant?

You should ask yourself:

• Do we keep a register of all medical devices in use, including issue dates and maintenance records?
• Are staff trained to report device concerns or malfunctions—formally and promptly?
• Do we have clear procedures for quarantining faulty devices and arranging replacements?
• Are records auditable, and is governance in place for ongoing review?

💼 How Swift Management Services Can Help

At Swift Management Services, we understand the operational pressures you face. That’s why we offer:

🔧 Device Compliance Audits

We’ll assess your current systems, from handheld thermometers to hoists, to ensure compliance with MHRA and CQC expectations.

📚 Staff Training

We deliver easy-to-follow, practical training on device handling, incident reporting, and PMS documentation.

📁 Policy & Procedure Updates

We can revise or create your Medical Device Policy, tailored to your setting—whether that’s a nursing home, GP clinic, or supported living service.

📊 Governance Dashboards

Want to demonstrate your compliance during inspections? We’ll help you create a digital compliance tracker, aligned with Quality Statements and key lines of enquiry.

🏁 In Summary

The medical device compliance landscape is evolving fast. Providers who act now will not only ensure resident and patient safety—they’ll also future-proof their services from potential regulatory risks.

If you’re unsure where to start, Swift Management Services is here to help. Whether you need a full device audit or just a policy refresh, our experienced consultants are ready to support you.

📞 Contact us today at robert.york@swiftmanagement.org.uk or call 020 8087 2072 to arrange a free, no-obligation consultation.