According to the government’s own advice:
“If you place certain medical devices on the EU market you or your designated authorised representative must register with the competent authority (national health regulator) in the EU state where you have an office or place of business. In the UK, Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority for the registration of medical devices. MHRA will only register manufacturers or authorised representatives that have a place of business in the UK.”
It is interesting to note that there are well-known manufacturers, based in the UK, who sell their medical devices into nursing homes and hospitals, yet they are not registered with MHRA.
As well as being the right thing to do, registering with MHRA provides a route to traceability and product safety – the MHRA hold many responsibilities, amongst which is market surveillance and the power to issue safety alerts and product recalls.
By buying off an unregistered manufacturer, there is the potential to put patients and carers at risk with untraceable products, and with so much guidance available to manufacturers, importers and distributors from MHRA and other agencies, there are no excuses.
When purchasing medical equipment, amongst the many considerations should be whether the items being purchased have been built to the correct standards and relevant directives. An EC Declaration of Conformity, is a vital document that offers the buyer some assurances about the product they are buying. Here is how the HSE describe it:
“It is a formal declaration by a manufacturer, or the manufacturer’s representative, that the product to which it applies meets all relevant requirements of all product safety directives applicable to that product. It is a sign that a product has been designed and constructed for compliance with relevant essential requirements, and has been through the appropriate conformity assessment processes.”
It may be surprising that there are still items being placed on the healthcare market in the UK that are not supported by this formal documentation process. We recommend asking prospective suppliers to provide an EC Declaration of Conformity and not just rely on a ticking of the “CE mark” box on a standard PPQ form – at the end of the day, standards and directives are there for good reasons – in the case of medical equipment, they have been developed, refined and updated to make sure that patients and care staff are kept safe.
Look out for our forthcoming post soon, about another issue: MHRA Registration and why that is important too.