MHRA (Medicines & Healthcare Products Regulatory Agency) & the supply of regulated Medical Devices

European Directive 93/42/EEC (the ‘Medical Devices Directive), together with UK implementing legislation, sets out a legal framework for the protection of the public in terms of the design, production and bringing to market of specialist products aimed at helping individuals overcome or manage difficulties they experience by reason of disease, injury or handicap. Such products are designated as ‘medical devices’, and this type of product needs to be regulated because many of the people who will rely on such products are dependent, infirm and / or vulnerable.

 

The regulated supply of medical devices combines two elements, firstly manufacturers of medical devices must comply with the formalities of registration with MHRA, and secondly the design and production of all medical devices which a manufacturer produces must conform to prescribed quality-centred standards. The regulatory regime is compulsory - production of what constitutes a medical device without compliance means a manufacturer is operating unlawfully.

 

Nevertheless, it is a little known fact that many ‘mobility’ beds available today are not manufactured by genuine specialist MHRA-registered manufacturers at all, but are instead low-cost low-quality ‘lookalikes’ made and promoted by general sales companies which have no track record or direct involvement in the professional mobility field, and no interest in the dependent and vulnerable individuals they target - apart from taking money off them, of course.

 

It is easy to check whether a manufacturer is MHRA-registered or not: MHRA maintains a public access database of all registered manufacturers which can be accessed at the UK Government MHRA website (search online: ‘mhra public database’).

CLICK ON THE MHRA LOGO -  to access our PDF downloads. The PDF on Where to Buy gives a complete explanation of how the MHRA regulation process works, what it means for the consumer, and why you should never source an adjustable bed that is needed for healthcare reasons from a non-MHRA-registered business.

 

If you are looking for a ‘mobility bed’ - and supplementing the MHRA information above - everything you need to know about adjustable bed build-quality issues in order to protect yourself from making an expensive mistake is discussed in our bed Build Quality PDF.

 Office:


ORWOOD MOBILITY MANUFACTURING


56 Coneygrey Spinney, Flintham

Newark

NG23 5LN

Contact:

If you wish to talk about your needs or any of our product solutions,  please call us or e-mail:

 

01636 525164 01636 525164

info@orwood.co.uk

 

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