Newport Business Park

New Port Road, Ellesmere Port, CH65 4LZ

Phone: +44 151 559 1160

Email: sales@cmlex.com

YOUR ACTIONS

Home | Your Actions

There are different requirements depending on each manufacturer’s current circumstances, these possible circumstances are outlined here:

EU-Type Examination Certificates (issued by CML UK):

For products with an EU-Type Examination certificate issued by a UK Notified Body such as Eurofins CML, and does not have an equivalent EU-Type Examination certificate issued by a non-UK Notified Body such as CML B.V., the UKCA mark is mandatory if being placed on the market in Great Britain (England, Wales and Scotland) from the 1st January 2021. A Quality Assurance Notification (QAN) issued by a UK Approved Body will also be required. If the same product is to be placed on the EU market after the 1st January 2021 then you need to take action now as you will need an EU-Type Examination certificate and Quality Assurance Notification (QAN) issued by a non-UK Notified Body, such as CML B.V.

EU-Type Examination Certificates (issued by CML BV):

For products with an EU-Type Examination certificate issued by a non-UK Notified Body, the CE mark can continue to be applied until the 1st January 2022 if being placed on the market in Great Britain (England, Wales and Scotland). A Quality Assurance Notification (QAN) issued by a non-UK Notified Body will be required. If the product is to continue to be placed on the market in Great Britain after the 1st January 2022 then certification from a UK Approved body such as Eurofins CML should be sought prior to this date. There are no actions required if the same product is to be placed on the EU market after the 1st January 2021 so long as any applicable Quality Assurance Notification (QAN) is issued by a non‑UK Notified Body, such as CML B.V.

Quality Assurance Notification (QAN)(issued by CML UK):

For manufacturers with a Quality Assurance Notification (QAN) issued by a UK Notified Body such as Eurofins CML, and do not have an equivalent Quality Assurance Notification (QAN) issued by a non‑UK Notified Body such as CML B.V., any products manufactured under that Quality Assurance Notification (QAN) that are being placed on the market in Great Britain (England, Wales and Scotland) from the 1st January 2021 are required to have a UK Approved Body Type Examination certificate and carry the UKCA mark. If the same product is to be placed on the EU market after the 1st January 2021 then you need to take action now as you will need an EU-Type Examination certificate and Quality Assurance Notification (QAN) issued by a non-UK Notified Body, such as CML B.V..

Quality Assurance Notification (QAN)(issued by CML BV):

For manufacturers with a Quality Assurance Notification (QAN) and products with an EU-Type Examination certificate issued by a non-UK Notified Body, the CE mark can continue to be applied until the 1st January 2022 to those products if they are being placed on the market in Great Britain (England, Wales and Scotland). If the manufacturer is to continue to place product on the market in Great Britain after the 1st January 2022 then a Quality Assurance Notification (QAN) and EU-Type Examination certificates from a UK Approved body such as Eurofins CML should be sought prior to this date. There are no actions required if the same manufacturer is to place the same products on the EU market after the 1st January 2021 so long as any applicable Quality Assurance Notification (QAN) and EU -Type Examination certificates are issued by a non‑UK Notified Body, such as CML B.V..

Technical Files stored by CML UK

Technical files are typically submitted for storage to a Notified Body at the time of the product being placed on the market and the product is a single production item. In this case, no action is required to be taken. If the product is subject to serial production, and a technical file has been submitted for storage at a Notified Body, the following considerations will have to be made with regards to any products placed on the market after the 1st January 2021.

 Technical file storage of serial production products:

For products with a technical file currently stored by a UK Notified Body, and do not have an equivalent storage at a non-UK Notified Body, the UKCA mark is mandatory if being placed on the market in Great Britain (England, Wales and Scotland) from the 1st January 2021. If the same product is to be placed on the EU market after the 1st January 2021 then action needs to be taken now as a technical file will be required to be stored at a non-UK Notified Body, such as Eurofins CML B.V. 

Technical Files stored by CML BV

Technical files are typically submitted for storage to a Notified Body at the time of the product being placed on the market and the product is a single production item. In this case, no action is required to be taken. If the product is subject to serial production, and a technical file has been submitted for storage at a Notified Body, the following considerations will have to be made with regards to any products placed on the market after the 1st January 2021.

 Technical file storage of serial production products:

For products with a technical file currently stored by a non-UK Notified Body such as CML B.V., and does not have an equivalent storage at a UK Notified Body such as Eurofins CML, the CE mark may continue to be applied to those products up to the 1st January 2022 if they are being placed on the market in Great Britain (England, Wales and Scotland). If the manufacturer is to continue to place product on the market in Great Britain after the 1st January 2022 then a technical file will be required to be lodged with a UK Approved body such as Eurofins CML.

There are no actions required if the same product is to be placed on the EU market after the 1st January 2021. 

Submitting Files from other Notified Bodies

Eurofins CML is accepting files from non-UK Notified Bodies. We have set out a threshold for the receipt of certification files for UKCA certification. The list here is a summary, the following slides provide more information on each requirement:

  • Copy of latest issue of applicable ATEX certificate
  • Consideration of incorporated parts
  • Full technical documentation
  • Assessed and tested to latest harmonised standards
  • Revised label drawings
  • No other changes are to be incorporated

The preparation of this package can be completed either by Eurofins CML (additional fees will apply, depending on the level of work involved), or can be completed by the non-UK Notified Body. All files are subject to acceptance, each file will be reviewed for completeness and Eurofins CML reserves the right to reject any files that may be deemed to fall below the level required.