JAE2 Consultancy​

  Key information, after the end of transition period:

• UK Notified Bodies will not be in a position to perform conformity assessment tasks pursuant to Union product.

• Manufacturers need to ensure that their designated responsible persons are established in the EU.

• Economic operators has either apply for a new certificate issued by an EU Notified Body,or arrange for a transfer of the file and the corresponding certificate from the UK Notified Body to an EU Notified Body.

• Goods placed on the EU market will have to fully comply with the provisions of Union law applicable at the time of their placing on the market. This means that, when required, they will have to indicate the details of an EU "responsible person".

• Both the EU Declaration of Conformity (drawn up by the manufacturer) and the Notified Body Certificate must be updated accordingly. These documents will need to mention that the certificate is now under the responsibility of an EU Notified Body and indicate both the old UK and the new EU Notified Body's details / identification numbers.

• Products manufactured, after the transfer of the certificate has taken place, should be marked with the new EU Notified Body number.

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  Guides:

EXAMPLE 1: Goods physically in the distribution chain or already in use in the EU or the UK market before the end of the transition period:

​A cosmetic product held in the EU by a wholesaler with a view to onward distribution or already on the shelf of a department store; an X-ray machine (medical device) certified by a UK Notified Body and held in the EU by a wholesaler or already supplied to a hospital in the EU, where it is in use.

 

These products are placed on the EU market before the end of the transition period and may be further made available on the market of the EU or of the UK and circulate between these two markets until they reach their end-users, be put into service (where applicable) and continue to be used in the EU or the UK with no need for re-certification, re-labelling or product modifications. This is without prejudice to the obligation to appoint a new responsible personor authorised representative, as the case may be, established in the EU where the current one is UK-based.

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EXAMPLE 2: Goods manufactured in the EU, the UK or in any other third country, sold to an EU customer before the end of the transition period after the manufacturing stage was completed but not yet physically delivered to the EU customer on that date:

A circular saw (machinery) manufactured in the US and certified by a UK Notified Body has been sold by the manufacturer to a Dutch factory on 15 December 2020 but will only arrive at Dutch customs on 15 January 2021.

 

Same as the goods under Example 1. The date of placing on the EU market is the date of the transaction (first supply) between the manufacturer and the EU customer after the manufacturing stage was completed. Placing on the market does not require physical delivery of the product.

 

EXAMPLE 3: Goods imported into the UK from a third country or manufactured in the UK, subsequently sold to an EU customer before the end of the transition period but physically delivered to the EU customer as of that date.

An X-ray machine manufactured in the US and certified by a UK Notified Body is sold to a UK wholesaler on 15 December 2020 and imported by the latter into the UK on 15 January 2021. The UK wholesaler then sells it to a Dutch hospital on 30 January 2021 and the X-ray machine arrives atDutch customs on 15 February 2021.

 

An X-ray machine manufactured in the UK and certified by a UK Notified Body is sold either directly by the manufacturer to the Dutch hospital or via a UK distributor, in both cases the date of the transaction with the Dutch hospital is 15 December 2020, arrival at Dutch Customs on 15 January 2021.

 

In both examples, the date of placing on the UK market is the date of the transaction (first supply) between the manufacturer and the UK customer (wholesaler/importer or distributor). Placing on the market does not require physical delivery of the product. The product is considered as placed on the UK market before the end of the transition period and may therefore be further made available on the market of the EU or of the UK and circulate between these two markets until it reaches its end-user, be put into service (where applicable) and continue to be used in the EU or the UK with no need for re-certification, re-labelling or product modifications. This is without prejudice to the obligation to appoint a new responsible person or authorised representative, as the case may be,established in the EU where the current one is UK-based.