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 Brexit nearing and the recent introduced UKCA arrangements we will continue to serve you. No matter where your company is located. If you wish to enter the UK market, we will guide you.
Over the past weeks we have received various questions around the UKCA requirements. In order to inform you properly we have developed a frequently asked question list, with the option to sign up to our news update.
Post-Brexit and UKCA
The UK has decided to leave the European Union (EU). This decision was formalised on 31 January 2020 and an agreed transition period is due to expire on 31 December 2020. As a consequence, many pan-European approaches to free movement of goods and product standards will no longer apply to the UK.
New regulations will be in place for both products manufactured in Europe and imported to the UK and, vice versa, products manufactured in the UK and exported to Europe. This includes arrangements for the legal control of measuring instruments used for trade (including non-automatic weighing instruments).
The EU Commission has confirmed that CE and other EU trade markings (e.g. MID) cannot be applied to relevant products by UK designated Notified Bodies after the transition period expires. The UK government has confirmed that those same relevant products will require UK Conformity Assessment (UKCA) markings for use in the UK.
The UKCA markings can only be applied by, or under the authority of a Notified Body established in the UK and accredited by the UK Assessment Service (UKAS). The UKCA arrangements will apply when the transition period expires. However, an additional twelve months of transition is in place where CE and other trade markings will be permitted for use in the UK. In effect the deadline for when UKCA markings should be applied is 1 January 2022.
There will be consequences for manufacturers of measuring instruments, covered by the MID and NAWI Directives. This document presents the answers to the most frequently asked questions.
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, cannot be longer placed on the UK market, without a dedicated UKCA conformity assessment. Additionally, manufacturers using the services of 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.
When will the transitional period end?
The transitional period where UK will accept MID or NAWI markings ends on 31 December 2021. This gives manufacturers more than a year time before they have to meet the new UKCA arrangements.
How will the UK conformity assessment be approached?
The UK government guidance indicates that the conformity assessment process is quite similar to that existing for Europe, including the conformity modules B, D, F and H1. Technical standards and requirements will be the same at the start of the arrangements but may change over time as and when British Standards divert from EU standards and are modified. It should be noted that UKCA conformity assessment requirements can only be conducted by a Notified Body established in the UK that is accredited by UKAS.
Is there a specific marking needed for the UK?
Yes. In the UK the UKCA marking will be introduced, as counterpart of the European CE and product specific regulatory markings. As noted above, it can only be applied by, or under the authority of, a UK Notified Body.
When is the UKCA marking mandatory?
The UKCA marking can be applied by a manufacturers, under the authority of a UK Notified Body, from 1 January 2021. UKCA markings will be mandatory from 1 January 2022 (i.e. after the transitional period ends). MID or NAWI marked measuring instruments can be placed on the UK market until the end of the transition period.
Can the same European harmonised standards and normative documents be used for the UKCA marking?
At the start British Standards will be used for UKCA purpose. These are currently aligned with EN standards. Over time there may be some divergence if the UK decides it needs different 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 the UK by a UK Notified Body. The UKCA quality system approval (module D) will also be required from the UK Notified 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.
Is it possible to use the same EU Notified Body, for products to be placed on the UK market?
This depends on which Notified Body is selected by the manufacturer and where the Notified Body is established. For UKCA the Notified Body needs to be established in the UK, be accredited by UKAS and be designated by UK government. For EU Notified Bodies the current requirements are maintained for Europe. However, they will not be able to apply UKCA requirements.
At NMi we are preparing ourselves to be able to meet UKCA requirements as soon as possible. This alongside maintaining our EU Notified Body. This results in NMi being 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.