Important Brexit update - Notified Bodies

5th Mar 2018

1) Document issued by the EU Commission on the 10th January

The part of concern is in the second paragraph which relates to notified bodies. It appears to suggest that type approvals issued by the UK notified body will cease to have effect in the EU27 on the date of departure of the UK from the EU. It advises that all certificates issued by a UK notified body should be migrated to EU notified bodies by that date.This means that businesses that place instruments on the market in the EU27 will almost certainly need to have type examination certificates and (Module B Type Approvals) and self verification approvals transferred to a notified body in the EU by that date.

2) Present advice from the UKWF with regard to Notified Bodies.

Please read this as some aspect is likely to affect you in the near future;

Outlines the potential problems with regard to future trade in the EU27. (Slides 2 and 3)
Businesses that use a self-verification (module D) certificate could be affeced from March 29th 2018. Module D approvals are subject to an annual audit, which means that any audit that takes place after March 29th 2018 may not be effective in the EU27 before the date of the next audit.
The effect of this is that the certificate will need to be replaced between March 29th 2018 and March 29th 2019 if businesses are to continue to carry on undertaking conformity assessment in the EU27 after March 29th 2019.

If a transition period is agreed there is the possibility that businesses may have longer to ensure that these requirements are met. We will know if there is a transition period on the 23rd March 2018. The UKWF feel it is unlikely that any transition period will clarify this matter, so to minimise any business risk it is advised that if you undertake conformity assessment in the EU27, the transfer to an EU notified body should be done as soon as possible.

 Module B Type approvals for use in the EU27.(Slide 4)
As considered above. If you have type approvals issued by the NMO and want to continue placing instruments on the market in the EU27 it is advised that these are transferred to an EU27 notified body by the the 29th March 2019.

The UKWF are visiting to notified bodies in the EU; the NMI in the Netherlands (https://www.nmi.nl) and Force in Denmark (https://forcecertification.com/en/about-force-certification-as/notified-body-0200/) with the intention of negotiating a cost effective process that will assist UKWF Members to transfer as smoothly as possible.

It is the intention to report back to UKWF Members at the next meeting in York on the 12th April which of the notified bodies we are approaching would be the best one, or if both would be able to accommodate this process. The UKWF will have a good idea of the costs and lead times for each Notified Body, and a method by which the transfer process can be achieved, to make the business decisions of members easier.

 Module B type approvals issued by a EU Notified body for use in the UK (Slide 5)
It is likely that these will need to be re-issued in the medium term to ensure compliance with future UK Legislation. Early discussions with UK Government suggest that it may be a number of years before legislative and administrative time could be found to achieve this. It is probable that we will continue to be able to use Type Approvals issued by EU Notified Bodies for the foreseeable future. It is assumed that type approvals issued by the NMO will be able to be used for placing instruments on the market in the UK after the date that we leave the EU.

 EU Module D Conformity Assessment issued by the NMO for use in the EU27 (slide 7)
If you have a module D conformity assessment approval issued by the NMO that is used for initial conformity assessment in the EU27, it is advised that you change this to a certificate issued by a notified body from the EU27. The UKWF have been working closely with the authorities in Ireland (The NSAI) to set up a notified body there that will offer the module D conformity assessment approvals. This would enable instruments to continue to be initially verified in the EU27. 

The UKWF hope to set up this relationship later in 2018, so that UKWF members can apply to this notified body and continue to be able to verify instruments in the EU with a hiatus. Further details should be available at the next UKWF Meeting. 

Module D approvals issued by an EU Notified Body for use in the UK (Slide 8)
It is likely that these will need to be re-issued in the medium term to ensure compliance with future UK Legislation. Early discussions with UK Government suggest that it may be a number of years before legislative and administrative time could be found to achieve this. It is probable that we will continue to be able to use Module D approvals issued by EU Notified Bodies for the foreseeable future. It is assumed that module D (self-verification) approvals issued by the NMO will be able to be used for placing instruments on the market in the UK after the date that we leave the EU.

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