Europe

  • 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 Council Directive 95/46/EC of 24 October 1995

– 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

Lien
 

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Clinical research Consultants is a clinical and regulatory affairs CRO, based in central Paris, with activities throughout EU, US, Asia and the Middle East. CC Clinical research Consultants is particularly focused on compliance to moral, legal and scientific integrity. The company ensures full compliance with GCPs, ethical, legal and regulatory requirements governing the conduct of clinical research worldwide.