In 2010, Europe witnessed one of the most alarming medical device failures in history: the PIP breast implant scandal.

A French company had used industrial-grade silicone — meant for mattresses and upholstery — in breast implants, exposing over 100,000 women across 60 countries to toxic material. These implants were prone to rupture, causing pain, inflammation, and long-term illness.

But the real tragedy?

💔 No traceability.

💔 No records.

💔 No accountability.

Thousands of women were never contacted, never warned, and never helped.The lesson was painfully clear:

When medical devices aren't traceable, lives are unprotected.

Thanks to the lessons of PIP, the UK has redefined how we manage non-invasive medical devices.

Though active alternating mattresses don’t go inside the body, they play a critical role in preventing pressure ulcers, which affect over 700,000 people in the UK each year.

Today, these products are legally classified as Class IIa Medical Devices, and subject to full MHRA regulation under:

• UK MDR 2002 (SI 2002 No 618)
• Medical Device Regulation 2017/745 (EU)

No audit?
No registration?
No market access.

At Squirrel Medical, we uphold the highest standards of regulatory integrity:

• ✅ Certified to ISO 13485:2016 (medical device QMS)
• ✅ Independently audited by SGS, an MHRA-approved Notified Body
• ✅ Registered on the MHRA PARD database
• ✅ Product labelled with valid UKCA/CE mark and 4-digit Notified Body ID
• ✅ Backed by clinical data, traceability, and recall protocols

“If a person breaches enforcement under UK MDR, they may face imprisonment or fines.” — MHRA Regulation 60

Healthcare Providers: Your Legal Duty

Under the Health and Social Care Act 2008 and Health & Safety at Work Act 1974, NHS Trusts, care homes, and hospitals must ensure:

• Equipment is safe
• Devices are certified and registered
• Procurement meets CQC & MHRA guidance

⚠️ Using non-compliant mattresses?
That’s a breach of duty of care — and potentially criminal.

Procurement Teams should:

1. Verify Registration

• Use MHRA’s Public Access Registration Database (PARD)

1. Request Proof

• UKCA or CE Certificate
• ISO 13485 Certificate
• Validity confirmation from the Notified Body’s website

1. Ensure Traceability

• Full documentation trail
• Recall procedures in place

Many assume compliance is the manufacturer’s problem. It’s not.

If you're distributing unregistered or unaudited active mattresses, you could face:

• ⚠️ Criminal liability
• ⚠️ Loss of NHS contracts
• ⚠️ Reputational damage

📣 But here's the opportunity:

• With over 70% of legacy suppliers removed from the market due to non-compliance, the gap is wide open.

We’re not just compliant — we’re committed.

• ✔️ Fully MHRA-registered (Class IIa)
• ✔️ Independently audited by SGS
• ✔️ Backed by peer-reviewed clinical data
• ✔️ Transparent documentation & recall-ready
• ✔️ Trusted by care homes, hospitals, and community providers
• “In this new regulatory landscape, compliance isn’t a bonus — it’s your shield.”

📞 Take the Compliant Path Forward

To check our certifications or explore distribution opportunities:

📱 Call: 0845 003 7979
🌐 Visit: www.squirrelmedical.co.uk

• “Because the next scandal won’t be about what you didn’t know — it’ll be about what you didn’t verify.”