The Market Surveillance Regulation seeks to improve product compliance controls at the EU borders by:
laying down rules and procedures for economic operators;
strengthening market surveillance of products covered by EU harmonisation legislation; and
providing a framework for controls at the EU border.
Companies placing these products on the EU market, who do not yet identify a responsible person established in the European Union, or who rely on an economic operator established in the United Kingdom, should assess their obligations and take the necessary steps.
Products supplied to EU Customers or offered for sale online, are presumed to be making available products on the EU market if the offer is targeted at end users in the EU, i.e., if the economic operator directs its activities to a Member State by any means.
The Market Surveillance Regulation also establishes an obligation of cooperation with market surveillance authorities for all economic operators, including information society service providers.
Regulation introduces new requirements for ‘economic operator’s’ CE Marked goods will be prohibited from being placed on the EU market unless there is an economic operator established in the EU or his Authorised Representative holds a copy of the technical file and Declaration of Conformity and resides in the EU.
The economic operator is responsible for ensuring the conformity documentation is available, co-operating with market surveillance authorities and informing authorities if there are reasons to believe that a product presents a risk. The new requirements relating to an economic operator will impact many businesses based outside the EU, including UK businesses.
An economic operator can be any of these:
the manufacturer of the goods,
the importer (where the manufacturer is not established in the EU),
an authorised representative, or
a fulfilment service provider when none of the above are established in the EU.
Article 3 of the Regulation provides definitions for these four terms.
A ‘manufacturer’ is any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under its name or trademark.
An ‘importer’ is any natural or legal person established within the Union who places a product from a third country on the Union market.
An ‘authorised representative’ is any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on its behalf in relation to specified tasks with regard to the manufacturer's obligations under the relevant Union harmonisation legislation or under the requirements of this Regulation.
A ‘fulfilment service provider’ is any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services.
Currently machinery manufacturers based outside the EU must have a person to ‘compile’ the Technical File who must be identified on the Declaration of Conformity. This person’s only responsibility is for providing a Technical File on reasoned request from authorities such as trading standards or health and safety authorities.
The new Regulation requires an Authorised Representative with a mandate to co-operate with the authorities if there is no other economic operator.
The full list of EU legislation covered by the Regulation is available in the Annexe I to the Regulation published here.
To bolster market surveillance, a Union Product Compliance Network is being established from January 1st 2021. This will ‘serve as a platform for structured coordination and cooperation between enforcement authorities of the Member States and the Commission, and to streamline the practices of market surveillance within the Union, thereby making market surveillance more effective’. This new Union Product Compliance Network makes it all the more important that manufacturers meet the requirements relating to economic operators and Authorised Representatives.
As the UK left the EU on 31 December 2020. Businesses based within the UK are no longer located within the EU for the purposes of CE marking and will therefore need to appoint an Authorised Representatives within the EU. Similarly, companies wishing to sell goods within the UK will need to appoint a UK Authorised Representatives who will have the same obligations and responsibilities as an EU Authorised Representatives.
The CE Marking Authority can provide a UK and EU Authorised Representatives service for manufacturers based outside the UK and Europe