- Europe, Device Regulations : MDD
– Link to Council Directive 2007-47 of 5 September 2007
– Link to Council Directive 2001/20/EEC of 4 April 2001 concerning medical devices
– Link to Data Protection Regulation (GDPR) 2016/679
– Link to Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
- Links to Future Applicable Regulations
– Link to Link to MDR 2017/745
– Link to Link to IVDR 2017/746
– Link to Link to Regulation on Clinical Trials on Medicinal Products 536/2014
- MEDDEV
2.7/1 – Clinical Evaluation : Guide for manufacturers and notified bodies
2.7/3 – Clinical investigations : serious adverse reporting
2.12/1 – Guidelines on a Medical Devices Vigilance System
2.12/2 – Post Market Clinical Follow-up Studies