Directives Archives

CE marking

The European “New Approach” Directives are the basis for CE (Conformité Européenne) marking. According to these directives, products must meet certain requirements before being sold in the EU, with manuals playing a vital role in the regulatory process. In order to ensure that your product is able to be widely distributed within the EU, it’s important to know what the European New Approach Directives mean, and exactly how they will impact you and the manuals of the products that you offer.

CE-marking medical software

Medical devices, such as infusion pumps and MRI scanners, need to be certified according to European CE rules. For a manufacturer, however, it is not always clear whether his product needs a ‘medical’ CE certification. This is especially true for any embedded software.

What are mandatory instructions?

Do mandatory instructions exist, whether these would be mandatory online instructions, mandatory operating instructions or any other kind of working instructions? Actually, they do not. There is nothing ‘mandatory’ about instructions. The term ‘mandatory instruction’ has its merits though. One could interpret mandatory instructions as instructions that should meet certain criteria.

European directives and… manuals

Almost all countries in Europe are member of the European Union, or are somehow affiliated to the EU. This has important consequences for setting up any manual. In the EU, the European directives on the safe use of a product also have something to say on the requirements for the accompanying manual. As such, a company can be held accountable if a manual is not in compliance with the relevant European directive.

Machinery Directive 2006/42/EC

Every machine that is marketed or used within the European Union must comply with the health and safety requirements from the Machinery Directive. Only if your machine meets these requirements, the machine may be traded within the entire EU. By affixing the CE mark, you declare that your machine complies with the Machinery Directive and possibly other CE guidelines. Next to requirements regarding the design, the Machinery Directive also states demands regarding the documentation. This blog lists the requirements from the Machinery Directive on the manual.

New radio equipment directive

The new directive for radio equipment ( 2014/53/EC) repeals R&TTE directive (1999/5/EC). The new directive applies to: “electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radiodetermination, or an electrical or electronic product which must be completed with an accessory, such as antenna, so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radiodetermination;”