What is an EC Declaration of Conformity?

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.