15 Oct NMi your partner for meeting UKCA requirements
NMi your partner for meeting UKCA requirements
NMi is and will be your single point of contact when it comes to worldwide legal metrology. With the EU/Brexit agreement in place and the recently introduced UKCA arrangements we will continue to serve you. No matter where your company is located. If you wish to enter all or any of the EU, UK and Northern Ireland markets, we will guide you.
We have received various questions around the UKCA requirements. To support players in the measuring instrument market we have developed a frequently asked question list, with the option to sign up to our news update.
Post-Brexit and UKCA
The UK decided to exit the European Union (EU) in June 2016. This signalled the start of Brexit discussions and negotiations between the EU and UK governments that resulted in the EU/UK Trade and Cooperation agreement. One part of the agreement was the requirement for the UK to replace the European CE mark with UKCA (or UKNI for Northern Ireland) for all products under the scope of the relevant regulatory obligations.
The new UKCA/UKNI arrangements went live on 1 January 2021, with a one-year transition to allow manufacturers requiring UKCA for their products to gain the relevant UKCA/UKNI certifications.
Measuring instruments covered by the Measuring Instruments Directive (MID) and Non-Automatic Weighing Instrument Directive (NAWI), and formally designated in the UK Measuring Instrument Regulations 2016, are within the scope of products requiring UKCA or UKNI markings by the deadline of 1 January 2022.
Additional arrangements were made for Northern Ireland. For relevant products to be placed on the Northern Ireland market there are regulatory provisions for UKNI conformity assessments and marking. In short, both UKNI and European CE conformity assessment and markings can be used in Northern Ireland.
Alongside its EU operations NMi will soon be able to provide UKCA services through an established UK branch. Northern Ireland requirements can also be accommodated by continued acceptance of applicable European CE conformity assessment.
Frequently Asked Questions
What are the consequences of Brexit on the arrangements for conformity assessment of measuring instruments covered by the MID or NAWI Directives?
Brexit means the UK is not a member of the European Union. As a consequence, following a dedicated transitional period until 31 December 2021, measuring instruments conformity assessed under MID or NAWI, can no longer be placed on the British market. After the deadline all measuring instruments, designated in UK legislation, will need to meet conformity assessment against UKCA requirements by UK Approved Body (and have relevant UKCA marking affixed).
Additionally, manufacturers using the services of former UK Notified Bodies will from 1 January 2021 need to find and use the services of an EU Notified Body if it wants to place measuring instruments, under MID or NAWI, on the European market. From 1 January 2021 former UK Notified Bodies, established in the UK, are not permitted to issue European conformity assessments.
It is worth noting that arrangements for Northern Ireland are different. Measuring Instruments can be placed on the Northern Ireland market can use either European or UKNI conformity assessment and use applicable markings.
When will the transitional period end?
The transitional period where UK will accept MID or NAWI markings ends on 31 December 2021.
How will the UK conformity assessment be approached?
The UK government guidance indicates that the conformity assessment process is currently consistent to that used in Europe, including the conformity modules B, D, F and H1. Technical standards and requirements will be the same at the start of the arrangements. However, this may change over time if British Standards divert from EU standards.
It should be noted that UKCA conformity assessment requirements can only be conducted by an Approved Body established in the UK that is successfully assessed and accredited by UKAS. Approved bodies are designated by UK government (BEIS).
Is there a specific marking needed for the UK?
Yes. In the UK the UKCA (UKNI for Northern Ireland) marking has been introduced, as replacement for European CE and product specific regulatory markings. As noted above, it can only be applied by, or under the authority of, a UK (or UKNI for Northern Ireland) Approved Body.
When is the UKCA marking mandatory?
The UKCA/UKNI marking can be applied by manufacturers, under the authority of an UK Approved Body. UKCA/UKNI markings will be mandatory from 1 January 2022 (i.e. after the transitional period ends) for relevant products placed on the UK market. MID or NAWI marked measuring instruments can be placed on the British market until the end of the transition period (i.e. 31 December 2021). MID or NAWI marked measuring instruments can continue to be placed on the Northern Ireland market (or UKNI markings are applicable).
Can the same European harmonised standards and normative documents be used for the UKCA marking?
British Standards are used for UKCA/UKNI purposes. These are currently aligned with EN standards. Over time there may be some divergence if the UK decides it needs different or modified requirements.
Are there other consequences for the module B and D conformity assessments?
Yes. A separate UKCA type examination certificate will need to be issued for instruments to be used in Great Britain by an UK Approved Body. The UKCA quality system approval (module D) will also be required from the UK Approved Body. Furthermore, in their Declaration of Conformity manufacturers have to declare compliance with relevant UK regulatory requirements.
Is there a need for a manufacturer to have a local office in the UK after the Brexit?
UK government policy will dictate the requirements. Based on historical precedent it is likely a manufacturer presence, established in the UK, will be required as UK regulations can only be applied to organisations subject to UK law.
Can a single product certification organisation offer EU and UKCA conformity assessment services? EU notified bodies must be established in and designated by an EU Member State. For the UK, an UKCA Approved Body must be established and designated by UK Government (BEIS). Respective decisions must be made by staff resident in the EU Member State (for CE and product specific EU conformity assessments) and Great Britain (for UKCA conformity assessments). If a single organisation has entities established and designated in both the EU and UK it can offer both EU and UKCA services – but conformity assessment decisions must be made independently and by staff residing in the relevant location.
At NMi we are preparing ourselves to be able to meet UKCA requirements as soon as possible, alongside maintaining our EU Notified Body. NMi will be able to support manufacturers with module B, D and H1 conformity assessments, for both the EU and the UK. Our preparations have started, and we will keep our customers updated on progress.