The European Machinery Directive was created twenty years ago as Directive 89/392/EEC and came into effect on January 1, 1995. Amendments followed in 1991 and 1993, and in 1998, the original Directive and its amendments were consolidated in the single Directive 98/37/EC.
The new directive 2006/42/EC [PDF link] addresses a number of problems with the original directive, such as overlap with other regulations. 2006/42/EC replaces 98/37/EC and came into force on December 29, 2009.
But the updated Machinery Directive also raises a number of questions. Chief among them are: Does it apply to me? What is covered under the definition of "incomplete machines"? And: What languages and translations are required?
The answer to the first question is pretty straight-forward: General and active implantable medical devices that also are machinery (as defined in 2006/42/EC) are, in fact, subject to the MDD and AIMDD, respectively - but also to the essential health and safety requirements in directive 2006/42/EC.
The requirements for so-called "incomplete machines" have been re-formulated in the new version of the directive. While a manufacturer declaration has sufficed in the past, moving forward a declaration of incorporation will be required. This declaration of incorporation must specify which requirements of the directive apply to the incomplete machine and have been complied with. And installation instructions must be included with the documentation.
That gets us to the third question: Language and translation requirements.
The Machinery Directive relies on some standard EU language in this regard. For instance, section 1.7.4 states that
All machinery must be accompanied by instructions in the official Community language or languages of the Member State in which it is placed on the market and/or put into service."But in the updated directive, the requirements for instructions for use have been considerably extended. The words "Original instructions" or "Translation of the original instructions" must now be used, as appropriate.
Section 1.7.4 of the directive goes on to specify general principles and minimum requirements for the contents of the instructions but, also in typical EU fashion, does not provide black-and-white guidance on translation requirements. For that, we need to rely on others [PDF link], like consultants and translation providers.
Just this morning, a lab equipment manufacturer asked me:
If a geography has more than one community language, is it sufficient to provide translation in just one of those languages, or should translations be available in ALL of those languages?In these kinds of situations, I generally recommend a two-step approach:
- You should assume that you need to provide translations in all of the languages of a given country.
- Everything is negotiable. With other directives, I have been amazed to see what manufacturers have been able to "get away with" at times. If you think that you have a good case for providing French but no Dutch in Belgium, have your regulatory group make the case to the Belgian competent authority. They may or may not agree but it's likely that a compromise of some sort can be worked out. (One question, of course, is: Does that effort take longer/cost more than simply doing a Dutch translation?)
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