The Machinery Directive 2006/42/EC requires that 'there must be a person authorised to compile a Technical File who must be established in the Community'. This person is responsible for making the Technical File available if required by EU Health and Safety Authorities. The reason is to ensure that Technical Files can be made available when required.
The 'person' can be a company that is based in the EU, it can be a subsidiary company of a global parent company, it can be an authorised representative. A Declaration that does not list the person authorised to compile the Technical File iis not compliant with the Machinery Directive and the compliance is difficult to prove.
Extracts from the Guide to application of the Machinery Directive 2006/42/EC Edition 2.1 – July 2017: -
Words in italics are from the Directive text, and a legal requirement. Comments below are from the Guide, in normal text.
Machinery Directive 2006/42/EC Annex II 1 A
The EC declaration of conformity must contain the following particulars: …
- name and address of the person authorised to compile the technical file, who must be established in the Community;
All machinery manufacturers must indicate the name and address of the person authorised to compile the technical file. That person is a natural or legal person established in the EU who has been entrusted by the manufacturer with the task of assembling and making available the relevant elements of the technical file in response to a duly reasoned request from the market surveillance authorities of one of the Member States. Essentially there must be a contact point in the EU for non-EU manufacturers. It is also required by other EU legislation like the Outdoor Noise Directive 2000/14/EC.
ANNEX VII A (continued)
- Failure to present the technical file in response to a duly reasoned request by the competent national authorities may constitute sufficient grounds for doubting the conformity of the machinery in question with the essential health and safety requirements.
Section 3 of Annex VII A states that failure to present the technical file in response to a duly reasoned request may constitute sufficient grounds for doubting the conformity of the machinery in question. Failure to present the technical file is not proof of the nonconformity of the machinery but, if the manufacturer does not communicate the relevant elements of the technical file, the market surveillance authorities are entitled to decide what action to take on the basis of whatever other evidence is available to them.