Borderline and Classification in the community Regulatory Framework for Medical Devices
April 05 2011
Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Or alternatively, borderline cases are those cases where the product falls within the definition of a medical device but is excluded from the directives by their scope. Where a given product does not fall within the definition of medical device or is excluded by the scope of the directives, other community and/or national legislation may be applicable.
Different interpretations of community legislation occur and can put public health at risk and disort the internal market. Both issues are of great concern to Member States and the Commission. Therefore, the Commission wishes to facilitate a dialogue among regulators and industry where diverse interpretations exist.
To this end, the working party on borderline and classification comprimised of Commission services, experts of Member States and other stakeholders meet on a regular basis to discuss borderline and classification cases in order to ensure a uniform approach. The borderline and classification meeting's primary aim is to provide for a forum to exchange opinions, and possibly reach consensus.
This manual represents the views agreed in this group on products, or categories of products which have raised doubts. The Commission, Member States and other stakeholders concluded that guidance is needed which goes beyond abstract rules and addresses their actual application.
A copy of the manual is available here. version1_8_borderline_en.pdf