Do you use a UK Notified Body?
If you currently ‘CE’ mark your product under EU rules, you will still be required to do so post-Brexit, as pre-existing EU rules will still apply within 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, must obtain these services from an alternative EU Notified Body to ensure unhindered access to the EU market post-Brexit.
If your business currently relies on a UK Notified Body, you need to either:
- Transfer your files from your UK Notified Body to an EU-27 Notified Body
- Obtain a new certificate which has been issued by an EU-27 Notified Body
You should find out whether your UK Notified Body has established itself in an EU-27 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 'NANDO' website to find an EU Notified Body. The EU 'NANDO' website is a database of all the EU Notified Bodies that can carry out conformity assessment under EU product legislation.
The UK has indicated that in the case of a disorderly Brexit when the UK leaves the EU, all UK Notified Bodies shall become UK Approved Bodies. The UK also intends to roll out an equivalent to CE marking, called 'UKCA' marking, which will be required instead of CE marking in order to access the UK market post-Brexit.
The EU Commission has published a guidance document entitled "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, also outlining the changes for economic operators such as the manufacturer, importer, distributor and authorised representative within the supply chain. The EU Commission has also published further guidance in a document entitled "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 transition period in place.
More information on CE marking, conformity assessment and product certification is available at dbei.gov.ie/brexitready
The Blue Guide on the implementation of EU product rules provides guidance for EU product rules and information to manufacturers, importers and distributors about their responsibilities.
Further information about CE marking, which products must be CE marked, EU harmonisation legislation for CE Marking and the steps which are involved in the process can be found here: http://ec.europa.eu/growth/single-market/ce-marking/index_en.htm
There are some types of product which require the intervention of a qualified third party, known as a Notified Body, during the conformity assessment process. Notified Bodies are typically a certification body, inspection body or a test house. There is a requirement that before a product can be legally placed on the European market, it must be certified by a Notified Body with EU Notified Body status. You can search for and visit the EU 'NANDO' website to find a notified body which meets this criteria.
To be appointed as a Notified Body, an organisation must meet the requirements set out in the relevant Directive and must normally be established in a Member State and be designated by that Member State's notifying authority to perform the appropriate conformity assessment tasks.
These Notified Bodies are appointed under and operate to specific national legislation which transposes the provisions of a corresponding European Directive. These Directives apply throughout the European Economic Area (EEA).
To find out further information, you should consult the EU's ‘Blue Guide’ on the implementation of EU product rules and the 10 Steps to CE Marking here on our website.
What will happen after Brexit?
- All Notified Bodies in the UK will cease to be recognised as EU Notified Bodies and you will no longer be able to use their services for product certification in order to meet EU countries' requirements.
- Your products will need to be certified (‘CE’ marked) by an EU Notified Body and you will need to find a suitable EU Notified Body that can certify your product(s).
- 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 occurs or else 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 to an EU-27 Notified Body. You should start the process by taking the following steps:
- Check the EU ‘NANDO’ website for a Notified Body based in one of the countries within the EU-27.
- Contact the new Notified Body and find out what you need to do to transfer your product certification. If you do this post-Brexit, you will be required to start with a new application.
- If you import from the UK, you will be required to keep additional information. Engage with your UK supplier(s) to obtain this information as soon as possible.
- If you have businesses based in both the UK and EU-27 consider how you might reorganise your business processes to minimise disruption to your supply chain.
NSAI are currently notified for a range of different product types across the following sectors; Construction, Medical Devices and Metrology.
Contact the Brexit Unit on BrexitUnit@NSAI.ie for any queries related to standards or certification for your business post-Brexit.