When Medical Device companies do business in Europe, they are required to conform to the EU’s Medical Device Directive, 93/42/eec. One important way to comply is to use the applicable standards from the Harmonised List for Medical Devices.
What is a European Directive? It’s a legislative act, rather than a regulation, that requires a specific outcome but does not dictate how that outcome is to be achieved. Countries are given a specific timetable for conformance with the directive. The Treaty that created the functioning of the European Union states, “A directive shall be binding, as to the result to be achieved, upon each Member State to which it is addressed, but shall leave to the national authorities the choice of form and methods.”
With the adoption of the New Approach methodology for directives, there is the ability to create a directive that is not based on specific limits or tests, but on “essential requirements.” This allows for the European market itself, through the mechanism of the EN Standards, to set the details of limits and tests rather than through specific language in the directive itself.
So for a limited number of directives, there are lists of Harmonized Standards that define the requirements for each. These European Standards are created at the regional level and then adopted as national standards in each member country. However, the standards are not mandatory — their use is still considered voluntary. So in principle an alternative means of proving compliance with the safety requirements of the directives is possible.
One last question to answer — How are directives amended? Due to the way in which directives are generated, it takes a directive to modify a directive. So 93/42/eec has been amended 5 times, by 98/79/EC, 2000/70/EC, 2001/104/EC, 2003/32/EC, and 2007/47/EC. Luckily, there is a consolidated reprint of the Medical Device Directive, issued in 2007, that consolidates the original text with these 5 amendments.
The Directives and European Standards are all available from Document Center Inc. at our website, www.document-center.com. Or contact us by phone (+650-591-7600), fax (+650-591-7617) or email (firstname.lastname@example.org). Our expert staff is available Monday through Friday, 8 am to 5 pm California time, to help you with your Standards needs.