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European CE mark, Technical File, Design Dossier * Medical Device Submissions * Regulatory Insight
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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).
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