If you supply CE marked products, including machinery, into the EU you need to be ready for the new Regulation 2019/1020 on market surveillance and compliance of products. This Regulation comes into force on 16th July 2021 and aims to strengthen the requirements for market surveillance by Member States; however, there are also important implications for manufacturers and suppliers.
Regulation 2019/1020 introduces requirements relating to an ‘economic operator’ and certain goods are prohibited from being placed on the market unless there is an economic operator established 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 as defined in point 1 of Article 2 of Directive 97/67/EC of the European Parliament and of the Council, parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council, and any other postal services or freight transport 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.
However, from 16th July 2021 the new Regulation requires an Authorised Representative with a mandate to co-operate with the authorities if there is no other economic operator.
The requirements apply to products affected by Directives listed in Annex I of Regulation 2019/1020 including 2006/42/EC (Machinery Directive), 2014/30/EU (EMC Directive), 2014/35/EU (Low Voltage Directive) and 2014/68/EU (Pressure Equipment Directive).
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.
Hold Tech Files Ltd. can act as the person to compile Technical Files for the Machinery Directive, and can act as the Authorised Representative for any of the Directives listed in Annex I of Regulation 2019/1020.
For more information go to www.holdtechfiles.eu