Do you use a UK Notified Body?
If you currently ‘CE’ mark your product under existing EU rules, you will be required to continue to do so post-Brexit as existing EU requirements will still apply in Ireland.
The EU Commission has advised that all EU product suppliers who currently rely on a UK Notified Body for certification of conformity to support their product declaration for ‘CE’ marking purposes, need to obtain an alternative EU Notified Body in preparation for Brexit.
If your business currently relies on a UK Notified Body, you need to either:
- Transfer your files from UK NB to an EU 27 Notified Body
- Get a new certificate by an EU27 Notified Body
You should find out whether your UK Notified Body has established itself in an EU27 member state as some UK Notified Bodies have relocated to the EU 27. If they have not established themselves in an EU member state, please consult the EU Commission NANDO website to find an alternative Notified Body. The EU NANDO website is a database of all designated bodies which can carry out conformity assessment under EU product legislation. You can find the Commission’s NANDO website at http://ec.europa.eu/growth/tools-databases/nando
The UK has indicated that in the case of a 'disorderedly Brexit' when the UK leaves the EU, all UK Notified Bodies will become UK Approved Bodies’. It also intends to bring in a UK equivalent to ‘CE’ marking called 'UKCA' marking which will be required instead of 'CE' marking to access the UK market.
The EU Commission published guidance "Notice to stakeholders: Withdrawal of the United Kingdom and EU rules in the field of industrial products" in January 2018 which confirmed that UK Notified Bodies will lose their status as EU Notified Bodies when the UK leaves the EU and outlines the changes for economic operators such as the manufacturer, the importer, the distributor and the authorised representative in the supply chain. The Commission published further guidance "Questions and answers related to the United Kingdom's withdrawal from the European Union with regard to industrial products" in February 2019 which provides further information in relation to industrial products in the event of the UK leaving the EU without a ratified withdrawal agreement or ordered transition period.
More information on CE marking, conformity assessment and certification is available at dbei.gov.ie/brexitready
The Blue Guide on the implementation of EU product rules provides guidance on EU product rules and information for manufacturers, importers and distributors on their responsibilities.
Further information about CE marking, the products that are CE marked, Union harmonisation legislation providing for CE Marking and the steps to follow can be found here: http://ec.europa.eu/growth/single-market/ce-marking/index_en.htm
There are some product areas in which requires the intervention of a qualified third party, known as Notified Body, in the conformity assessment procedure. Notified Bodies are typically a certification body, inspection body or test house. There is a requirement that before a product can be placed on the European market, it must be certified by a body recognised as an EU Notified Body.
To be appointed a Notified Body, an organisation must meet the requirements as set out in the relevant Directive and must normally be established in a Member State and be designated by the Member State notifying authority for performing the conformity assessment tasks.
These Notified Bodies are appointed under and operate according to the specific national legislation which transposes the provisions of the corresponding European Directive. These Directives apply throughout the European Economic Area (EEA).
To find out further information, consult the ‘Blue Guide’ on the implementation of EU product rules and the 10 Steps to CE Marking on the NSAI website.
NSAI are currently notified for a range of product types across the following sectors, Construction, Medical Devices and Metrology.
Contact the NSAI Brexit Unit at BrexitUnit@NSAI.ie for any queries on standards and certifications and your business post-Brexit.
What will happen after Brexit?
- All Notified Bodies in the UK will cease to EU Notified Bodies and you will no longer be able to use them for product certification for EU countries.
- Your products will need to be certified (‘CE’ marked) by an EU Notified Body and you will need to find another EU Notified Body to certify your product.
- The details of all EU Notified bodies are available on the EU NANDO website (http://ec.europa.eu/growth/tools-databases/nando/)
All products certified by a UK Notified Body must be placed on the market before Brexit or they will need to be recertified.
What must I do now?
If you currently use a UK based Notified Body, you will have to move an EU-27 Notified Body. You should begin the process by taking the following steps:
- Check the EU ‘NANDO’ website for a Notified Body based in the EU-27.
- Contact the new Notified Body and find out what you need to do to transfer product certification.
- If you import from the UK, you will be required to hold additional information. Engage with your UK supplier to obtain this information as soon as possible.
- If you have businesses based in both the UK and EU-27 consider how to reorganise your processes to minimise disruption.