As a UK based manufacturer, beyond the end of 2021, can we still apply the CE mark to our product and sell it in Europe, or is that the responsibility of the importer?
Yes, you can continue apply the CE mark and to sell the products in Europe but you will need to appoint an Economic Operator based within the EU to provide a point of contact for the market surveillance authorities.
We manufacture class II medical devices in the UK. We have a Notified Body certificate that was issued in 2019 by a UK based notified body. Can we continue to CE mark our products and sell them in Europe and the UK?
No. All certificates issued by UK based Notified Bodies ceased to be valid on 1 January 2021. You need to contact the company that issued the certificate and ask them about getting it re-issued by a European office.
I understand that certificates issued by UK Notified Bodies are invalid for CE marking from 1 January 2021. My product is certified by a Notified Body based in Italy. Do I have to get a certificate from a UK Approved Body in order to sell into the UK?
The UK will allow properly CE marked products to be placed on the market until 31 December 2021 (30 June 2023 in the case of medical devices). A certificate from a UK Approved Body will only be required if the UKCA mark is also applied, or is applied instead of the CE mark.
What is the difference between a ‘Notified Body’ and an ‘Approved Body’
A Notified Body is an organisation which is ‘notified’ by a Member State to the European Commission as being competent to fulfil the audit functions defined in one or more of the CE marking directives. An Approved Body performs the same function in the UK, for UK legislation.
Does UKCA apply to goods manufactured and sold before 2020 which are refurbished regularly back to the same specification to which they were originally manufactured and are then re-distributed throughout the UK?
Where maintenance and refurbishment of product takes place that does not affect the performance or has no other effects relating to the health and safety aspects of the product (i.e. a like-for-like replacement of worn components) then the product can continue to be re-sold under its original CE mark without the application of the UKCA mark.
Certifications of welders and welding procedures under the Pressure Equipment Directive are performed by recognised third-party organisations (not Notified Bodies. After Brexit, UK-based RTPOs will lose their EU accreditation. To what extent can an EU based Notified Body continue to accept UKCA based approvals for welding and NDT given the fact that the EU and UKCA approvals are technically identical and only the papers change?
Notified Bodies and Approved Bodies are accredited to make their own decisions about the acceptability of processes and personnel so it does not necessarily follow that RTPO accreditations can no longer be recognised by an EU Notified Body after Brexit.