Some of the Applicable Regulations

  • 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

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Clinical Research Consultants offers management and flexibility in the conduct of clinical trials in many countries. Local reulatory knowledge and experience are ensured thanks to the locally based monitors/CRA.