When does an operator / employer become a manufacturer?

According to the Machinery Directive, a machine manufacturer is anyone who assembles machines or machine parts of various origins and places them on the market.

The manufacturer may be either the machine builder himself or the operator.

An operator becomes the manufacturer when he purchases a machine and places it on the market in the EU for the first time.

Should an operator assemble a new plant out of different machines, so that various subsystems form a new machine, then he too becomes the manufacturer. This constitutes a "significant change", which means that a full conformity assessment procedure needs to be carried out.

In Germany, the national implementation of the European-wide Machinery Directive into German law takes the form of the Machine Ordinance (9th ProdSV/Product Safety Act). This deals with the subject of a "Significant change to machinery".

On 9 April 2015 the German Ministry for Employment and Social Affairs published an interpretation paper on this subject. The decision as to whether the modifications on a machine constitutes a "significant change" in accordance with this paper can be derived as follows.

Even though this interpretation was made explicitly for Germany for the Product Safety Act, the requirements it contains are very much applicable for other European countries insofar as they concern a "significant change to machinery".