CE Marking

The European Union legally requires that any medical device or IVD must meet certain requirements before it can be sold. The requirements are laid out within the Medical Devices Directive (MDD 93/42/EEC), In Vitro Diagnostic Device Directive (IVD 98/79/EC) or the Active Implantable Medical Device Directive (AIMD 90/385/EEC). The manufacturer will have to declare in a so called Declaration of Conformity, that the product complies with the Essential Requirements of the applicable Directive. There are several steps involved before a Declaration of Conformity can be issued. Depending on the classification of the device, the CE mark can be achieved through self assessment or a certification body.

CLINSTEP can guide you through the CE marking process.

Our Services include:

• Assisting in the classification of your device
• Assisting in fulfilling the Essential Requirements
• Assisting in the preparation and review of your technical file
• European Authorized Representative for non European manufacturers