CE marking for medical devices
In order to be allowed for marketing in Europe, all medical devices must comply with the following Directives:.
- Medical Device Directive 93/42/EEC,
- Active Implantable Medical Device Directive 90/385/EEC
- New Directive 2007/47/EC, amending the MDD and AIMD
- In Vitro Diagnostic Directive 98/79/EC
The 'CE' mark indicates that a product can be marketed in the EU without any trade restrictions.
A ‘CE’ mark may only be affixed on a product after a conformity assessment has been conducted by the manufacturer. Merc supports its customers through all the different steps of this process.