Medical device (MD and AIMD) and In vitro diagnostic medical devices (IVD) markets are based on an European regulatory framework, governed by three European directives:
- 90/385/EEC (June 20th 1990) for the active implantable medical devices, applicable from the January 1th 1995,
- 93/42/EEC (June 14th 1993) for the medical devices, applicable from the June 14th 1998,
- 98/79/EEC (October 27th 1998) for the in vitro diagnostic medical device.
These European directives were amended by the directive 2007/47/EC, which took effect the March 21, 2010 with implementation by member states. They provide a stiffer frame in term of clinical data for all medical devices classes.
The CE mark requires technical knowledge of the device and knowledge in terms of regulatory framework to set up the CE mark dossier and select the process with notify bodies and healthcare authorities.
Every Medical Device into the market must be in conformity with the applicable essential requirements. A strong understanding of this regulations and the ability to work effectively within this complex environment is crucial to obtain the CE mark in the minimal delay.
AD-DM Consulting supports your product at all life cycle stages, with the:
– Regulatory strategy definition
– Writing, update or compliance of the CE mark dossier
– Selection of the applicable standards and regulations
– Quality and conformity assessment
– Communication with notified Bodies
– Clinical investigation management to assess the medical device performance and detect adverse events (Annex X)
– ISO 13485 and iSO 9001 certification