Medical Device Vigilance

AXPHARMA has been taking part in all the major training programmes for ten years (MEDTECH, DIA), and has given input on regulatory issues for medical device vigilance.

axpharma-materiovigilance

AXPHARMA is thus able to adapt flexibly to deal with all relevant regulatory issues, and it acts confidently when nominated to represent its clients in dealings with various healthcare authorities. Thanks to its validated and carefully adapted procedures, AXPHARMA can:

• carry out case management
• draft ad hoc reports
• support the preparation of technical dossiers
• monitor medical device vigilance regulations

Medical device vigilance is carried out on medical devices after they have come on to the market and whether or not they bear the CE mark. It is not carried out on devices that are subject to clinical investigation.

The goal of medical device vigilance is to avoid the (re)occurrence of incidents and the risk of serious incidents (as defined by article L.5212-2) involving medical devices, by taking the appropriate preventive and/or corrective measures.

In order to best carry out this mission, the French National Agency of Medicine and Health Products Safety is in constant contact with:

• local medical device vigilance contact persons in healthcare establishments
• manufacturers
• whoever has any knowledge about an incident or the risk of an incident, including device users and third parties

Regulations

Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (O.J.E.C. 20 June 1990), modified by Directive n°93/68/EEC of 22 July 1993 (O.J.E.C. 30 August 1993).

Medical Device Directive (MDD): Directive 93/42/EEC of 14 June 1993 concerning medical devices (O.J.E.C. 12 July 1993) modified by Directive 2000/70/EC of 16 November 2000 (O.J.E.C. 13 December 2000).

Directive 98/79/EC on in vitro diagnostic medical devices (IVDD).

Directive 2000/70/EC as regards medical devices incorporating stable derivates of human blood or human plasma.