Derek Coulson is a Director of Hold Tech Files Ltd, based in the Republic of Ireland. He has worked in the field of machinery Safety since 1995 and is currently a Technical Advisor with Safe Machine Ltd
If you supply CE marked goods or products, (including machinery), into the EU, there is a new Regulation 2019/2020 on market surveillance and compliance of products that comes into force on 16th July 2021. It strengthens the requirements for market surveillance by Member States.
The new Regulation prohibits the placing on the market of certain goods unless there is what is called an ‘economic operator’ established in the EU, with responsibility for ensuring that the necessary 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.
These ‘economic operators’ are defined as: -
the manufacturer of the goods,
the importer (where the manufacturer is not established in the EU),
a fulfilment service provider when none of the above are established in the EU, or
an authorised representative.
They are defined as: -
‘manufacturer’ means 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;
‘importer’ means any natural or legal person established within the Union who places a product from a third country on the Union market;
‘fulfilment service provider’ means 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 ( 31), parcel delivery services as defined in point 2 of Article 2 of Regulation (EU) 2018/644 of the European Parliament and of the Council ( 32), and any other postal services or freight transport services;
‘authorised representative’ means 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;
For machinery manufacturers based outside the EU, there must currently be a person to ‘compile’ the Technical File, identified on the Declaration of Conformity: effectively someone to provide the Technical File within the EU. This person has no responsibility other than providing a Technical File on reasoned request from authorities, who could be Trading Standards, Health and Safety Authorities etc.
From July 2020, 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 2019/1020.
A Union Product Compliance Network is being established from January 1st 2021: the purpose of the Network is to ‘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’.
MachineBuilding.net readers might want to note that Hold Tech Files Ltd can act as the ‘person’ to compile Technical Files for the Machinery Directive, and that the company can also can act as the Authorised Representative for any of the Directives listed in Annex I.