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The UKCA (UK Conformity Assessed) marking is a new UK product marking that will be used for goods being placed on the market in Great Britain (England, Wales and Scotland). It covers most goods which previously required CE marking. As with CE marking, UKCA marking is the manufacturer’s declaration that a product fulfils relevant regulations and standards, including safety, health and environmental protection requirements. A broad range of products marketed within the borders of Great Britain must fulfil the UKCA marking requirements.
UKCA marking was introduced on January 1, 2021 and manufacturers can now use the UKCA on a voluntary basis. There is a transition period during which CE marking will continue to be recognized and after that only the UKCA mark is accepted.
DEKRA is committed to supporting its customers with the implementation of UKCA marking and currently has partner agreements in place to offer solutions for products certified according to the ATEX, RED, EMC, LVD, PPE, OND and Machinery Directives. DEKRA is a UK Approved Body (UKAB) for equipment intended to be used in potentially explosive atmospheres and is in the process to become a UKAB to certify medical devices.
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You will need UKCA marking, if you place your equipment for potentially explosive atmospheres / hazardous locations on the market in Great Britain.
UKCA marking has been introduced on 1 January 2021 after which manufacturers can use it on a voluntary basis, if their products already have CE marking. There is a transition period until 31 December, 2022, when Great Britain continues to recognise CE marking.
From 1 January 2023, all ATEX related products need to be UKCA (UKEx) certified and CE-marking will no longer be recognized. The UK Government has announced an intended update to legislation concerning UKCA marking: CE certification completed before 31 December 2022 may be used by manufacturer to declare existing product types as compliant with UKCA. Products must still bear UKCA marking and will need to undergo conformity assessment with a UK Approved Body (UKAB) at the expiry of the certificate or after 5 years from the introduction of the requirements (31 December 2027), whichever is sooner. From 1 January 2023, changes to any existing CE marked products and/or Quality Assurance Notification (QAN), which were used to apply UKCA marking by manufacturer prior to 31st December 2022 and all new products without CE marking including new QAN will require assessment by a UKAB.
DEKRA Certification UK Ltd is part of the DEKRA organization and is a UK Approved Body (8505) for equipment intended to be used in potentially explosive atmospheres. This designation enables DEKRA Certification UK Ltd to evaluate and certify products to the UKEX requirements.
Across the DEKRA network, we work cooperatively to minimize the additional activities required for UKCA marking where our customers already have CE (ATEX) marking. Where possible, we perform an abridged UKCA assessment using existing CE reports and combine activities to maintain certificates with your existing CE marking schedule. Existing customers are encouraged to apply for UKCA certification via their current Project Manager or directly using the following email firstname.lastname@example.org.
Please note, if you have CE marking for your equipment from DEKRA Certification BV (0344), DEKRA Testing and Certification GmbH (0158) or another EU Notified Body, your certificate remains valid in the European Economic Area. If you are located in Great Britain, you need to appoint an authorised representative or responsible person based in order to place goods on the market in the EU.
All medical devices placed on the market must be registered with the regulatory authority, Medicines and Healthcare products Regulatory Agency (MHRA). MHRA will have oversight of all devices on the UK market and will implement vigilance, sampling, and reporting activities as well as managing incidents. Manufacturers located in the UK can register their products directly with MHRA. Manufacturers outside the UK will need to appoint a Responsible Person to register their products.
DEKRA is committed to supporting its customers with the implementation of UKCA marking. We are developing a robust UKCA conformity assessment process to be delivered from our DEKRA UK legal entity when designated by MHRA (expected mid-2022) as a UK Approved Body. The process is facilitated by the extensive experience of our two European Notified Bodies and our existing UK network and infrastructure.
UKCA-marking for medical devices requires a third-party assessment process by a UK Approved Body. This process is similar to that currently followed in the EU for CE marking, where the conformity assessment of devices is carried out by a designated Notified Body. However, MHRA has confirmed that until June 30, 2023 UKCA-marking will be based on the MDD 93/42/EEC, IVD 98/79/EC and AIMD 90/385/EEC Directives and not the EU Regulations 745/2017 (MDR) and 746/2017 (IVDR).
Once designated by MHRA as a UK Approved Body, DEKRA will align the UKCA marking conformity assessment activities to the existing cycle of CE marking activities and integrate them into the certification activities already scheduled, as far as possible.
DEKRA will keep its customers informed about the next important deadlines and timings. If customers have any specific questions or concerns, they should not hesitate to contact their usual DEKRA contact.
Timelines for registration can be found here: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk#registrations-in-great-britain
In our FAQ, you will find the answers to the questions we get time and again. Check it out frequently, because we will add more questions and answers to them from our experts.
New regulations, roles and changes relevant to placing medical devices on the UK market with the introduction of UKCA marking. Learn more about UKCA and DEKRA's process in this Greenpaper