Insight: Why active mattress compliance is now a legal and moral obligation

Gary Baker, Medical Devices Director at Squirrel Medical, outlines the tightening regulatory landscape surrounding active mattresses, where independent audit, MHRA registration, and full traceability are now mandatory under UK law — and non-compliance carries serious clinical, legal, and reputational consequences.

In a healthcare market increasingly defined by accountability and transparency, the UK’s active mattress sector is undergoing a seismic shift. Once a relatively unregulated field, it is now subject to rigorous legal controls under the UK Medical Device Regulations (UK MDR 2002). For those who manufacture, distribute, or sell active alternating mattresses used to prevent or treat pressure ulcers, the message is clear: compliance is no longer optional.

Under new MHRA enforcement, these products must now be independently audited and registered as Class 2a medical devices (Figure 1). The goal is not just to protect patients — though that is paramount — but to ensure that if something goes wrong, there is a system in place to trace, investigate, and respond.

The stakes are high. Both manufacturers and distributors who place non-compliant devices on the market can face criminal prosecution, with penalties including fines and up to six months in prison under the UK Medical Device Regulations (UK MDR 2002).

But it doesn’t end there.

Care providers, including NHS trusts, care homes, and private hospitals, also carry legal responsibilities. Under the Health and Safety at Work Act 1974, they have a duty to ensure that all equipment supplied to patients is safe, effective, and properly maintained. Continuing to use or purchase devices that have not been through the required MHRA registration and audit process may constitute a breach of this duty of care. In the event of patient harm or investigation, enforcement bodies such as the Care Quality Commission (CQC) or Health and Safety Executive (HSE) can hold not only suppliers but also the organisations using such equipment legally accountable.

The lessons of the PIP implant scandal

To understand why the MHRA has taken such a hard line, it’s important to revisit one of the most disturbing chapters in European medical device history: the Poly Implant Prothèse (PIP) breast implant disaster.

In 2010, it was discovered that a French company, PIP, had been manufacturing breast implants using industrial-grade silicone — the kind intended for mattresses and upholstery, not human implantation. These implants were cheaper to produce and allowed the company to significantly undercut competitors. But the consequences were catastrophic.

Over 100,000 women across more than 60 countries received the defective implants, many through cosmetic surgery clinics that had no idea they were sourcing unsafe devices. The implants were prone to rupture, and when they did, they leaked toxic industrial silicone into the body, causing pain, inflammation, scarring, and in some cases, systemic illness.

But the scandal didn’t end with defective products. The real tragedy — and the regulatory failure — came when authorities discovered that PIP had kept inadequate records of traceability. This meant that when the truth emerged, governments across Europe, including the UK, had no way of identifying all the women affected. Thousands were left unaware that they were carrying potentially harmful devices. Some were never found.

The PIP disaster was a wake-up call. It showed how insufficient oversight can become a public health crisis — not just medically, but ethically and legally. It’s one of the reasons the UK now classifies active pressure care mattresses as Class 2a medical devices, despite their non-invasive nature.

Why active mattresses are now regulated

Pressure ulcers — also known as bedsores — affect over 700,000 people in the UK, and it is estimated that another 300,000 are at high risk. Active mattresses, which automatically redistribute pressure using alternating air cells, are vital tools in prevention. They are often used in hospitals, care homes, and increasingly in community settings.

Until recently, manufacturers could bring active mattresses to market without undergoing independent audit or proving their clinical efficacy. There was little oversight into the electrical safety of these devices, the chemical composition of the foams and plastics used, or the manufacturer’s ability to trace and recall products if needed.

That has now changed.

Under UK law, all active mattresses must be subjected to a third-party conformity assessment. These audits, conducted by MHRA-appointed approved bodies such as SGS, review the entire lifecycle of the product — from design and materials to manufacturing processes, risk management, reliability, and post-market surveillance. Manufacturers must also prove that the product has measurable clinical benefits and does not pose unreasonable risk to patients or caregivers.

Once these criteria are met, the company is issued a Quality Assurance Certificate to ISO 13485 and a UKCA certificate (figure 2), which is submitted to the MHRA. If approved, the product is added to the MHRA’s PARD database — the official public record of legally registered Class 2a medical devices.

Any company not listed on the PARD database is operating outside of the law.

Dealers and distributors: Caught in the legal net

Many distributors may assume that responsibility lies solely with the manufacturer. That assumption is dangerous — and incorrect.

If you are supplying or placing active mattresses on the UK market that have not undergone proper conformity assessment and MHRA registration, you could be held criminally liable. Ignorance is not a defence under the law.

This legal exposure goes beyond compliance. In the event of an adverse incident — for example, a patient injury caused by mattress failure — investigators from the CQC or HSC will request evidence that the product was legally registered. If you cannot provide it, you may be considered complicit in the supply of an unregulated device.

And let’s not forget: in the digital age, public perception moves fast. A failure in traceability or safety can lead to not just legal action but reputational ruin.

A commercial opportunity in a tighter market

While the regulatory burden may seem heavy, it also presents a significant commercial opportunity. With over 70 percent of previous suppliers no longer able to trade, there is a clear gap in the market for distributors who can offer MHRA-registered, clinically validated mattresses.

Early adopters will gain market share, build trust with NHS and private clients, and position themselves as leaders in compliance. Those who delay may find themselves shut out of tenders, investigated for non-compliance, or worse — held liable for harm.

One such compliant supplier is Squirrel Medical, one of the few UK-based manufacturers fully certified under UK MDR 2002. Its active mattress systems are:

• Registered on the MHRA’s PARD database as class 2a
• Independently audited by SGS to UK MDR
• Backed by published clinical data
• Supported with full traceability and recall protocols

For dealers, this means more than a product — it’s a protected, growing revenue stream backed by legal credibility.

Compliance is not a burden — It’s a standard

The shift to a more regulated market was inevitable. After decades of reactive enforcement, the MHRA is now proactively defending patient safety. And with lessons from the PIP scandal still resonating, traceability is no longer a luxury — it is a moral and legal obligation.

For distributors, the path forward is clear: partner only with manufacturers who can provide certified proof of compliance. Ask for evidence of MHRA registration (check the MHRA PARD database) and obtain a copy of their UKCA certificate. This is issued by an MHRA-approved body, such as SGS.

Demand transparency.

Because in this new landscape, it’s not just about selling devices — it’s about protecting lives and livelihoods.