Authorised Representative for The Machinery Directive & UK Supply of Machinery (Safety)Regulations
Manufacturers placing products on the EU or UK market have specific obligations under the EU Directives and UK Regulations. These include appointing and Authorised(where the manufacturer is not established in the EU or UK)
EU requirements: Directive 2006/42/EC of the European Parliament and of the councilof17 May 2006on machinery, aims to ensure that only safe products are made available to consumers. It defines a number of requirements for Manufacturers and distributors of products to ensure that products are safe, consumers are informed of any risks associated with products and dangerous products can be removed.
UK requirements: The UK’s Supply of Machinery (Safety)Regulations 2008aims to ensure that only safe products are made available to UK consumers. This defines a number of requirements for Manufacturers and distributors of products to ensure that products are safe, consumers are informed of any risks associated with products and dangerous products can be removed.
What products are in the scope of the Regulations?
The regulations apply to:
- Machinery
- Interchangeable equipment
- Safety components
- Lifting accessories
- Chains, ropes and webbing
- Removable mechanical transmission devices
- Partly completed machinery
However there are also some specific exclusions.
Obligations of the Authorised Representative
Manufacturers are able by written mandate to appoint authorised representatives to performall or part of the obligations and formalities imposed on manufacturers (either asmanufacturers or responsible persons) by the Regulations.
Mandated authorisedrepresentatives for the GB market can be based in GB or Northern Ireland but after 1 January 2021 cannot be based outside the UK.
A manufacturer can only mandate an authorised representative established in the UK, under the 2008 Regulations as they apply in GB. No GB-based authorised representatives are recognised under EU law. This means GB-based authorised representatives cannot carry outtasks on the manufacturer’s behalf for machinery being placed on the Northern Ireland or EEA markets.
Therefore, a GB manufacturer selling machinery to the EEA or placing on the NI market, who wishes to appoint an authorised representative to carry out tasks for them in respect of that machinery, must appoint an authorised representative based in Northern Ireland or the EEA
International Associated Recommended Scope:
Although the Directive and Regulation confirm that much of the compliance requirements can be carried out by the manufacture or his Authorised Representative, such as; carrying out a risk assessment etc Our experience is that most clients will complete these activities themselves, hence we recommend that our responsibilities are limited to the following.:-
a)Keep the EU declaration of conformity and the technical documentation at the disposal of national market Surveillance authorities for 10 years after the equipment or assembly has been placed on the market;
- Documentation check
- Verify the Declaration of Conformity
- Review the Technical Documentation
- Check where applicable that an appropriate conformity assessment exist and NB validity
- Keep the previous documentation (Declaration of conformity, Technical Documentation, certificates issued by Notified Body and amendments) at the disposal of competent authorities (at least ten years)
- Record Retention and Document control, including version controls.
- Ensure Labelling is correct and includes the details of the Authorized Representative.
b) Further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of the equipment or assembly;
c) Cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by the equipment or assembly covered by the authorized representative’s mandate.
Further Guidance
Further information is available at the European Commission’s website on Machinery
There is also a specific guideline that is available.
(https://ec.europa.eu/docsroom/documents/38022)
We also encourage you to review this guidance (linked below), alongside any other specific UK Government guidance that applies to your product.
https://www.gov.uk/government/publications/supply-of-machinery-safety-regulations-2008
Changing your Authorized Representative.
To be compliant, the manufacturer should address the following aspects:
The date of termination of the outgoing Authorized Representative and the date of start of the incoming one.
The date until which the manufacturer can show the outgoing AR on the information or promotional material.
The transfer of documents, including confidentiality aspects and property rights.
The obligation to the outgoing Authorized Representative to send to the manufacturer or incoming Authorized Representative, any complaints or reports from healthcare professionals and patients or users about suspected incidents related to the device for which it has been designated.
Contact Us
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