The new directive creates many potential pitfalls for manufacturers – even the definition of what a machine is has changed.
Opportunità e insidie della Direttiva Macchine
The new Machinery Directive once again makes life more difficult for manufacturers. Even its scope is different from that of the previous version. The first question a company thus needs to ask is, “Which of our products are going to be affected by this?” To make the situation even more challenging, there is no transition period. All products that fall within the scope of the new Machinery Directive must already conform to the directive’s specifications when it comes into force on 29 December 2009. Obviously, you can’t change the specifications of your machines and documentation overnight, so it’s important to get information and make preparations for the new directive well in advance. This is where the help of a specialised and experienced service provider like pdp can be invaluable.
Another important change is that a special procedure is now required for manufacturers who produce “incomplete” machines (also referred to as “part-machines”), who must now supply a declaration of incorporation, an installation manual and special technical documentation to their customers.
Manufacturers can now choose from different conformity assessment procedures for their declaration of conformity:
- EC type examination (review by a Notified Body) and internal production controls
- Process for full own quality assurance system approved by a Notified Body
These procedures require an EC type examination certificate or an approved quality assurance system. However, if a manufacturer’s products are designed and manufactured in conformity with the harmonised standards of the new Machinery Directive then it is also possible to opt for the:
- Procedure for conformity assessment with internal control of production, which means that the manufacturer can certify the product
The “storage of documents” and “inspection of documents for compliance with harmonised standards” procedures provided for in the old version of the directive are no longer available.
There are even changes in the regulations for the application of the EC mark.
As you can imagine with so many changes and new regulations, there are many potential pitfalls. This is where a service provider like pdp can help – with over 20 years of experience in technical documentation we can find economical solutions for implementation of the requirements of the new directive for your products and documentation. We’d be happy to discuss the options with you.
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