FIND OUT WHICH DIRECTIVES APPLY TO YOUR PRODUCT

Is your product a medical device? Or maybe it is a mecidinal product?Shoult it be considered as an active implantable medical device?

Stop asking yourself that and get started with our survey.

Directives & Regulations

A directive is a legislative act that sets out a goal that all EU countries must achieve, although it is up to the individual countries to devise their own laws on how to reach this goals. A regulation is a binding legislative act and must therefore be applied in its entirety across the EU.

The three main directives related with medical devices are:

Medical Devices: Dir 93/42/EEC aka MDD.
Active Implantable Medical Devices: Dir 90/385/EEC aka AIMDD.
In vitro Diagnostic Medical Device: Dir 98/79/EC aka IVDD.

With the use of the survey above, you will be able to know under which directive a particular product falls.

ATTENTION

Although directives try to define its scope as accurate as possible, there are different borderline products (products that could fit in different definitions and therefore is hard to say which directive must apply).

Use the Manual on Borderline and Classification in the Community regulatory framework for medical devices written by the European Commission.