Marketing your medical devices in Europe requires that you first obtain the CE mark for those devices. Medical Devices are regulated in Europe under Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended under Council Directive 2007/47/EC. Generally, this requires the establishment of a Technical File for all Class I, IIa, IIb and III devices, as well as a Design Dossier for all Class III devices. In addition, your company must obtain a Quality System Certificate, such as the ISO 13485 Quality System Certificate from a Notified Body, unless you only distribute Class I devices, in which case you can self-certify. Manufacturers of IVDs must follow the In Vitro Diagnostic Device Directive (IVDD 98/79/EC), and manufacturers of active implantable devices must follow the Active Implantable Medical Device Directive (AIMDD 90/385/EEC). Regulatory Insight has guided many companies through all of the above Directives and Certifications to obtain the CE mark for their medical device, IVD and active implantable device products. We would be delighted to assist your company with this process as well.