WHAT IS NON-COMPLIANCE AND WHY DOES IT MATTER?
In the Medical Equipment market, there are sadly many anomalies which lead to non-compliance, sometimes deliberately, sometimes inadvertently which leads to unregulated equipment being placed on the market. Typical examples of non-compliance are:
- Having no CE marking at all
- CE marking inappropriately, i.e. claiming conformity to “furniture” or “machinery” regulations, rather than Medical Device Directives
- Non-registration with MHRA
- Limited or non-existent product safety testing
- Stating a Safe Working Load yet having no testing methodology or audit trail
MHRA uses manufacturer’s own descriptions and marketing materials to assist in determining whether an equipment item is a medical device or not. So if literature is full of references
- “excellent for stroke patients”
- “adaptable for different postural and pressure care requirements” …. and so on,
…but the products displayed, are not
CE marked, are not
built to Medical Devices Directives, have passed no
safety tests, strength tests, and have no
demonstrable means of complying with anything other than “domestic furniture regulations”, what happens if there is an incident?
This is not scaremongering – underneath the burden of red tape, regulations and auditing processes that ethical medtech manufacturers abide by, are the following considerations:
- Patient Safety
- Prevention of Injury
- Caring for others whether they are our staff, patients or visitors to our premises
So when you are looking at a new supplier for Medical Equipment – new chairs, beds, mattresses, don’t just look at the brochures – look under the bonnet and make sure everything is as good as it looks on the surface! This is all basic stuff but you may be surprised to find out that many medical chairs (particularly) are on the market under a “furniture classification”, which is insufficient.
- Requirements for manufacturers to register with MHRA – view
- Medical devices: how to comply with the legal requirements – view
- Care-Med MHRA registration – Alrick & Wintur