Notified Bodies are organisations designated by the national governments of the EU Member States as being competent to make independent judgments about whether or not a product complies with the essential requirements laid down by each CE marking directive. In order to be Notified, the technical competence and management structure of the organisation must fulfil certain conditions and the name of the body, along with the details of the scope of its notified activities, must be given ('notified') to the European Commission.
These bodies are also the organisations which will be requested to give judgment on the safety of a product by the enforcement authorities in the EU and therefore will be responsible for judging which standards should have been applied to a product and if they have been applied correctly.
Up-to-date contact details for all Notified Bodies, as well as details of their scope of notification, can be found via the European Commission's NANDO database.
Mutual Recognition Agreements
Member States can only notify bodies within their own territories and so originally the only bodies which were notified outside of the EEA were subsidiaries of EU resident organisations. However, under the Mutual Recognition Agreements ('MRAs') between the EU and America, Canada, Australia, New Zealand and Japan, regulatory authorities in these countries can, in effect, designate Notified Bodies within their own territory. Further MRAs with countries of the former Soviet Republic, Israel and Asian countries are expected in due course.
It is important to understand that MRAs can only be made for directives for which there is corresponding legislation in each party to the agreement. For example, there can be no MRA between the EU and the USA on machinery because the USA does not have federal legislation which covers the safety of machinery.
The Europa website gives details of MRA's for a variety of countries.
Impact of Brexit
Now that the UK has left the EU, it is no longer a Member State, and since there is no MRA in place at present, the UK is no longer able to appoint Notified Bodies. Certificates from UK based former Notified Bodies ceased to be valid on 1st January 2021 and any manufacturer relying on a certificate from a UK based Notified Body for their CE marking now needs to get their product re-certified. In practice, this is not as bad as it sounds since most UK Notified Bodies have made arrangements to transfer their certification clients to subsidiary organisations based in a Member State.
The UK has adopted the requirements of the CE marking directives and Regulations into UK law as the basis for the new UKCA mark. This includes the need for independent certification in the same way, and for the same products, as for the CE mark, but the UK legslation now refers to what used to be Notified Bodies as 'Approved Bodies'. Every organisation which had Notified Body status in the UK in 2020 was offered the chance to become an Approved Body, and most of them have done so. There is a list on the .gov.uk web site.
The UK is now free to appoint bodies from outside its own territory if it wishes to, and so the list includes bodies from the USA, New Zealand and elswhere.
In theory, any manufacturer who needs a Notified Body Certificate for CE marking and an Approved Body certificate for UKCA marking is going to have to undertake two separate procedures and get two pieces of paper at the end. However, the technical requirements for testing and assessment of products will (for the moment, at least) be identical for CE marking and for UKCA marking, so in practice it is expected that most Approved Bodies will be able to help their customers with a fast-track path to Notified Body certification. Similarly, some Notified Bodies will undoubtedly see it commercially worth their while offfering thier clients a one-stop-shop for the necessary certification for both CE marking and UKCA marking.
Conformance's status
Conformance Ltd. specialises in consultancy and is not a Notified Body for any of the EU CE mark directives, nor are we an Approved Body for any of the legislation associated with the UKCA mark. The requirements for the management structure of Notified/Approved Bodies place certain restrictions on the way in which they can provide advice and assistance to clients whose products are being tested by them and we believe that we can offer a better and cheaper service to clients without these restrictions. Where necessary, we provide clients with recommendations on whom they should use as a Notified/Approved Body and while we have good working relationships with many, we do not have agency agreements with any. We believe that clients have a right to know that our recommendations are based on our understanding of their best interests, not on some undisclosed financial arrangement between ourselves and the certification body.
