Hotspot: Brexit Update on Requirements for Assessment Bodies for PED and UKCA Marking
What is it?
The BVAA has received an important clarification from the UK Government regarding the requirements for Assessment Bodies to the PED and the new UKCA Mark scheme during the Brexit transition period onwards. The content of this Hot Spot should be read alongside the previously issued BV002284 Updated Brexit Guidelines for the PED, dated October 2nd 2020.
The clarification received relates to CE marked and UKCA marked valve products and material to be used in main pressure-bearing parts for valves certified to category II and above. It should be noted that immediate action may be required by members to continue to place compliant products on the UK or EU market after 31st December 2020.
- Any Agreed MRA will not Include UK Approved Bodies or EU Notified Bodies
UK Government has confirmed that they had been hopeful of a Mutual Recognition Agreement (MRA) on conformity assessment (which may potentially have encompassed materials testing) however the EU has made it clear that they do not want the UK or EU to undertake conformity assessment for each other’s markets. We are aware this will result in duplication and cost for those serving both markets.
- UK Transition Measures Allow Use of the CE Mark in GB Market until 31st December 2021
UK Government transition measures allow for finished products or main pressure-bearing materials placed on the market by 31st December 2021 and complying with the requirements of the PED to be acceptable in the UK market. After this date, applicable product placed on the market in the UK must display the UKCA mark, and main pressure-bearing materials for product of Category II and above must have EN 10204 3.1 material certificates using an accredited QMS system that is approved by a Competent Body registered in the UK.
- No EU Transition Measures in Place After 31st December 2020 for CE Marked Product
Unlike the UK Government, the EU has not announced any transition measures after the 31st December 2020 concerning Notified Bodies or Competent Bodies for the PED. Therefore, following the clarification in 1 above it is important that members recognise the following:
- The Notified Body certifying product to the PED must be based in the European Union from 1st January 2021 to allow them to continue to place products on the market in the EU.
- If members intend to rely on the UK transition measures, rather than the UKCA mark, to place product on the market in Great Britain after 1st January 2021 then they must continue to comply with the PED and therefore must use the services of a Notified Body based in the EU from that date.
- CE marked product to Category II and above requires certification of main pressure-bearing parts by a material manufacturer which has a QMS accredited by a Competent Body in the EU. After 1st January 2021, materials placed on the market with EN10204 3.1 certificates accredited by a UK Competent Body will no longer be acceptable for CE marking. This may be an issue for manufacturers using UK material suppliers (ie foundries and forges) if they have not already put arrangements in place for certification to be accredited by an EU Competent Body.
- In the absence of certification as in c) above, EN 10204 3.2 certification (certificate of specific product control) will be required by your EU Notified Body which will involve additional costs.
- Use of UKCA Mark Requires Main Pressure-bearing Material Certificates Approved/ Accredited by a UK Body
It is implied that members using the UKCA mark to place Category II and above products on the market in Great Britain from 1st January 2021 will need to have their main pressure-bearing materials certified by a supplier who has a QMS system that is accredited by a Competent Body based in the UK. Alternatively, their UK Approved Body could conduct a specific inspection on the materials in order to approve an EN 10204 3.2 certificate.
- Appointment of an Authorised Representative
From 16th July 2021 UK manufacturers placing PED goods on the EU market must be represented in the EU by either an Authorised Representative or an Importer. These must be based in the EU in accordance with Directive 2019/1020.
Why is it Important?
There is a possibility that some materials intended to be supplied to members after 31st December 2020 may not have the appropriate certification to be used in valves placed on the UK or EU market. It is recommended that members supplying Category II valve products and above immediately contact their material suppliers to establish what arrangements they have in place for dual certification of their ISO 9001 QMS system by Competent Bodies based in the UK and the EU. They should also confirm the feasibility of material suppliers gaining EN 10204 3.2 material certificates from the appropriate conformity assessment body (UK or EU) if necessary.
It is also recommended that members put in place either an Authorised Representative or an Importer, based in the EU, to allow exports to the EU to continue beyond 16th July 2021.
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