EC Certification for distributing medical devices in France and the rest of Europe
The legal framework regarding medical devices marketed in France as well as the other European member states, is based on three directives:
- Directive 90/385/EEC regarding active implantable medical devices
- Directive 93/42/EEC for medical devices per se
- Directive 98/79/EC for in vitro diagnostic medical devices.
The last two directives regulate the main safety requirements and define the standard evaluation process and are applicable in France.
The EC certification consists in the application of these directives.
These regulations aim at ensuring patient safety and maintaining an appropriate level of health protection not only in France but also throughout the European Union.
These 3 main directives have been modified pursuant to several amending and implementing directives, including Directive 2007/47/EC on some technical aspects.
The medical devices that come within the scope of Directive 93/42 are classified into four categories according to the potential patient health risk.
Each of them has specific criteria of standard evaluation.
Because of numerous exceptions and particularities relating to classification, it is also vital to take into account the classification rules set out at supplement IX of the Directive.
Moreover the European Parliament has recently taken action to prevent another PIP type case (which came about in France) by implementing a new resolution and further changes to the current legislation are expected to be made over the coming months.