Directive 2006/42/EC of May 17, 2006 (also known as the “New Machinery Directive”) was transposed and implemented in Italy by Legislative Decree No. 27 of January 27, 2010, 17 (published on February 19, 2010, in Ordinary Supplement No. 36/L to the Official Journal, General Series – No. 41) and replaces Directive 98/37/EC of the European Parliament, in force since September 21, 1996 (also known as the “Machinery Directive”), published in the Official Journal No. Directive 207 of July 23, 1998, which applied to all types of machinery and their safety components placed on the market separately (and which, in turn, amended Council Directive 89/392/EEC of June 14, 1989).
European Union Directive 2006/42/EC applies to stationary, mobile, transportable, and lifting/handling machinery, although certain types of machinery are excluded from the scope of this Directive. The Directive defines the essential health and safety requirements that the aforementioned machinery must meet, from design and manufacture through to placing on the market.
The Directive places the machinery in two big macro groups:
- machinery which must be certified by notified third-party body
- machinery which the manufacturer can certify himself
Conformity of the Machinery listed in annex IV of the same Directive with the above mentioned requirements is established through a number assessment procedures carried out by an appointed body (Notified Certification Body).
For all other cases, it is sufficient to prepare and maintain a Technical File in accordance with the provisions of Annex VII of the Directive itself. In this case, the term “Technical File” is used for machines, and “Relevant Technical Documentation” is used for partly completed machinery.
Machinery placed on the market or modified after the Directive entered into force must bear the CE marking and be accompanied by the appropriate documentation. Products that do not meet the requirements of the Directive cannot enter the European Common Market (ECM).