The United Kingdom left the European Union at midnight on January 31 2020. This was followed by a transition period, which ends on December 31 2020. The transition period means that the United Kingdom will continue to be part of the internal market and the customs union and subject to the Court of Justice of the European Union. The European Union and the United Kingdom will use the transition period to negotiate the details of the future relationship.
Below, Swedac provides information about the possible consequences of Brexit for accredited bodies and manufacturers.
In brief, a no-deal Brexit will lead to the following:
- The European Accreditation Agency (EA) has confirmed that the United Kingdom’s accreditation body, the United Kingdom Accreditation Service (UKAS), will continue to be a member of the EA until January 31
- Accreditations issued by UKAS will continue to be valid to a certain extent.
- British notified bodies will lose their status as notified bodies.
- Manufacturers using British notified bodies will need to contact notified bodies in a country within the EU.
- Manufacturers must ensure that they have a certificate from a notified body in an EU country for products placed on the market after the United Kingdom’s withdrawal from the EU.
- Manufacturers of medical devices and the notified bodies involved will be requested to ensure the transfer of all relevant certificates, and to make the necessary adaptations to product labels, in order to allow manufacturers to continue to place their products on the EU market.
- Measuring instruments subject to the requirements of EU directives and with certificates issued by a notified body in the United Kingdom, and already in use before the date of withdrawal may continue to be used after the date of withdrawal.
- From January 1 2021, UKCA marking may be required for products placed on the British market. The CE marking will be available for use under certain conditions until January 1
What does a no-deal Brexit mean for notified bodies?
According to EU rules, a manufacturer is fully responsible for the products it places on the market, without any prior approval from national authorities. The manufacturer must carry out a conformity assessment procedure in order to demonstrate that the essential requirements have been met. In the preparation of the legislation, the legislator has a number of predefined procedures (so-called modules) available for use, and from these the legislator selects the procedures deemed relevant for the product category in question. The manufacturer may perform some of the procedures entirely on its own, while for other procedures, the manufacturer is required to engage an independent third-party body. The third-party bodies competent to carry out these tasks are notified by the Member States to the Commission, and are therefore called notified bodies.
A manufacturer may engage a notified body from any EU country, since EU legislation requires an open system for testing and inspection. If the United Kingdom leaves the European Union without an agreement in place, it means that notified bodies currently established in the United Kingdom will lose their status as notified bodies. Manufacturers of new products therefore need to contact notified bodies in a country within the EU in order for their products to be assessed in accordance with harmonised product legislation.
Manufacturers holding certificates, from notified bodies with their registered office in the United Kingdom, issued before the date of withdrawal, and with plans to continue supplying products to the internal market, are requested to consider applying for a new certificate issued by a notified body from the remaining EU members, EU-27, or to ensure that the certificate is transferred from the British notified body to a notified body within EU-27. The latter alternative is based on the agreements or arrangements already in place between these notified bodies, and the background is that a notified body must be established in the territory of a Member State and be under the supervision of the Member State. Following Brexit, the United Kingdom’s notified bodies will no longer be under the supervision of a Member State, and therefore no longer able to operate as a notified body within the EU. This also means that the certificates (type approvals) that these notified bodies have issued, and issues, will no longer be under appropriate supervision, and the certificates will therefore cease to be valid. As a consequence, a manufacturer wishing to place a product, which must be type-approved, on the market within the EU after Brexit, must ensure that the product has a type approval from a notified body that is under the supervision of a Member State.
Once a certificate has been transferred, the certificate must state that it is under the supervision of a notified body within the EU. The certificate must specify the details of both the new notified body and the previous British notified body. In which case, a product placed on the market within the EU or in the United Kingdom prior to the transfer of the certificate, or manufactured prior to the transfer of the certificate, does not need the designated identification number to be changed. Products manufactured after the transfer of the certificate must be marked with an identification number from a notified body within the EU, and the identification number from the previous British notified body may not be used.
It is mandatory for manufacturers, as well as for notified bodies to a certain extent, to monitor the validity of issued certificates.
Of special importance for medical devices
Manufacturers and the British notified bodies are requested to ensure, no later than December 31 2020, that the medical devices under their supervision:
- have a certificate/license, where appropriate, issued by a notified body established in the EU, and
- that there is an authorised representative within the EU for products manufactured outside the EU.
Of special importance for measuring instruments in use
As stated above, manufacturers must ensure that they have a certificate from a notified body in a country within the EU for products placed on the market after the date for the United Kingdom’s withdrawal from the EU. Measuring instruments subject to the requirements of EU directives and with certificates issued by a notified body in the United Kingdom, and already in use before the date of withdrawal may continue to be used after the date of withdrawal.
What does a no-deal Brexit mean for accredited bodies?
In cases where bodies have been accredited by the United Kingdom’s accreditation body UKAS, there may be uncertainty over whether a certificate or license will continue to be valid after a no-deal Brexit.
UKAS is one of the founders of the EA – the European cooperation organisation for accreditation bodies. On May 14 2020, it was decided that UKAS would remain a full member of the EA until January 31 2022. Work will now continue to enable UKAS to continue to be an active member of the EA after January 31 2022 as well.
If no agreement is reached by the end of the transition period, the EU will no longer recognise certificates issued by UKAS, since EU legislation requires conformity assessment to be carried out by a national accreditation body within the EU.
Regardless of whether UKAS continues to be a member of the EA in the longer term, UKAS is a contracting party to the global cooperation organisations for accreditation bodies, ILAC and IAF, and is therefore part of the global mutual agreement for parties to recognise each other’s accreditations. All in accordance with the principle of “Accredited Once, Accepted Everywhere”. Certifications, calibrations, inspections, tests and verifications performed by a body accredited by UKAS will continue to be valid in Sweden and in other states that are signatories to agreements of the global cooperation organisations for accreditation (ILAC’s MRA agreement and IAF’s MLA agreement).
What does Brexit mean for products being exported to the United Kingdom?
The United Kingdom is in the process of introducing its own conformity assessment system, UKCA marking, for products to be placed on the British market. From January 1 2021, the UKCA marking must be applied to the product in the following cases:
- if the product is intended for the British market,
- if the product is subject to legislation that requires UKCA marking,
- if the product requires mandatory third-party assessment,
- if a British conformity assessment body has carried out a conformity assessment and the certificates have not been transferred from the British body to a body recognised by the EU before January 1
This does not apply, for example, to the existing stock of a product that was fully manufactured and ready for placement on the market before January 1 2021. In these cases, the product can still be sold in the United Kingdom with CE marking, even if it is authorised by a certificate issued by a British body.
It will be possible to use the CE marking in the United Kingdom until December 31 2021, provided that:
- the CE marking is based on self-declaration,
- conformity assessment has been carried out by a notified body within the EU,
- certificates issued by a body approved in the United Kingdom have been transferred to a notified body within the EU.
CE-marked products can only be placed on the market in the United Kingdom if they meet the requirements within the EU, provided that the requirements within the EU and the United Kingdom are the same. If the rules change within the EU, and the CE marking is based on these new rules, the CE marking cannot be used within the United Kingdom. This also applies to any changes taking place before January 1 2022.
Swedish export companies must therefore be prepared to meet the requirements in order to be able to use UKCA marking.