Manufactured products must comply with the UKCA (UK Conformity Assessed) scheme if intended for the UK market.

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The new product marketing for good which are placed on the market in Great Britain (England, Wales and Scotland) was launched by the UK government on January 1, 2021. It covers most goods currently requiring a CE marking. Note that special rules apply for Northern Ireland, where the UKCA (UK Conformity Assessed) marketing is not sufficient. Instead UKNI or CE marking must be applied.

While the new scheme came into effect January 1, 2021, companies are given time to adjust. In most cases, you are still able to use existing CE marking until 31 December 2022.  For medical devices, the transition period is longer and currently set to June 30, 2023.

The UK legislative instruments and standards

The list of new UK Legislative Instruments that are comparable to the EU Directives must be references in your technical document instead of the EU legislation. You can find more information on the UK Government’s gov.uk using the UKCA marking pages. For a comparative overview of the EU and UK directives, please download our step-by step guide.

The UK government has published a list of UK Designated Standards which replace the EU Harmonized Standards. For now, the technical requirements to be met remain largely the same to the current edition of the European Harmonized standard. However, it is the manufacturer’s responsibility to verify compliance.

Review the governmental list of applicable UK Designated Standards. You must make sure these are listed in your technical documentation instead of the European Harmonized (EN) standards.

We strongly recommend that companies start preparing the transition the marking on products intended for the UK market as soon as possible.

The conformity assessment

Manufactured products are still either subject to self-declaration or a third-party conformity assessment. However, the conformity assessment must be performed by a UKCA notified body.

DNV is in an advanced stage of becoming a complete notified UKCA Body and soon able to support companies with both their UKCA and CE conformity assessments. We expect to be able to offer UKCA marketing for all manufacturers in September or October 2021, well in advance of the end of the transition period.

Currently, DNV has a limited UKCA Body notification for pressure equipment manufacturers in the UK, operating under the UKCA Body DNV Ltd entity.

Once the accredited certification body DNV Business Assurance Ltd is fully notified, DNV will be able to deliver UKCA conformity audits for the following scope:

• Hazardous: ATEX (Equipment & protective Systems for use in potentially explosive atmospheres);
• Pressure equipment: PED
• Construction: CPR (Construction Products: Structural Steels and Metallic Products).

A further scope extension application will be submitted mid-2021 for medical devices and other directives.

Validity of issued certificates

For all categories of certification offered by DNV’s EU Notified Bodies, a transitional period exists where CE Marking continues to be accepted for UK Market access until 31 December 2022. For medical devices this is extended to 1 July 2023.

What services do we offer?

DNV is a UKCA Body for Pressure Equipment and is at an advanced stage of application to extend scope to cover the remaining UK legislation in the following technical areas:

EU legislation (CE marking)	UK legislation (UKCA marking)
ATEX - Directive 2014/34/EU	Equipment and Protective Systems Intended for use in Potentially Explosive Atmospheres Regulations 2016
Pressure equipment - Directive 2014/68/EU	Pressure Equipment (Safety) Regulations 2016
Construction Products - Regulation (EU) No 305/2011	Construction Products (Amendment etc.) (EU Exit) Regulations 2020
Regulation (EU) 2017/745 on Medical Devices	Medical Devices (Amendment etc.) (EU Exit) Regulations 2020