2.9.5 英国のEUからの離脱

Since 1 February 2020, the United Kingdom has withdrawn from the European Union and has become a ‘third country’. The Withdrawal Agreement (82) provided for a transition period ending on 31 December 2020. Further information can be found in the Commission Notice to stakeholders on the withdrawal of the United Kingdom and EU rules in the field of industrial products (83)

The Withdrawal Agreement provides for certain separation provisions relevant to industrial products. In particular, Article 41 of the Withdrawal Agreement provides that an existing and individually identifiable good lawfully placed on the market in the EU or the United Kingdom before the end of the transition period may be further made available on the market of the EU or of the United Kingdom and circulate between these two markets until it reaches its end-user. Where provided in the applicable provisions of Union law, such a good may also be put into service in the EU or in the United Kingdom.

As of 1 January 2021, Union harmonisation legislation no longer applies to the United Kingdom. This has in particular the following consequences:

A manufacturer or importer established in the United Kingdom is no longer considered as an economic operator established in the Union. An economic operator established in the Union who, prior to the end of the transition period, was considered as an EU distributor of products received from the United Kingdom has become an importer for the purposes of Union product legislation in relation to products it places on the Union market after 1 January 2021. This operator has to comply with the more stringent obligations applicable to an importer, as regards in particular verification of product compliance and, where applicable, the indication of his contact details on the product or its label (84).

In some product areas, Union harmonisation legislation foresees certain economic operators with specific tasks and who must be established in the Union, for example authorised representatives, whose appointment by the manufacturer is generally voluntary, with the exception of medical devices (85) and marine equipment (86). These can no longer be established in the UK and must be established in the Union.

Former UK Notified Bodies have lost their status as EU Notified Bodies. As such, UK bodies are no longer in a position to perform conformity assessment tasks pursuant to Union product legislation.

When the applicable conformity assessment procedure requires or provides for the possibility of third party intervention, a certificate delivered by an EU Notified Body is required for products placed on the Union market as of 1 January 2021.

Economic operators must have applied for a new certificate to an EU Notified Body, or arranged for a transfer of the file and the corresponding certificate from the UK Notified Body to an EU Notified Body, to take over the responsibility for that certificate before the end of the transition period, on the basis of a contractual arrangement between the manufacturer, the UK Notified Body, and the EU Notified Body.

When a certificate has been transferred, 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.

If the above mentioned product documentation is in order, there is no need to change the Notified Body number for products already placed on the EU or the UK market or manufactured before the transfer of certificate took place and not yet placed on the EU or the UK market. However, products manufactured after the transfer of the certificate has taken place should be marked with the new EU Notified Body number and it will not be possible to continue to use the UK Notified Body number. (88)

The UK Accreditation Service ceased to be a national accreditation body within the meaning and for the purposes of Regulation No 765/2008 as from the end of the transition period. As a consequence, its accreditation certificates are no longer considered as ‘accreditation’ within the meaning of Regulation No 765/2008 and no longer valid or recognised in the EU pursuant to that Regulation as of 1 January 2021.