European Union Commission Release New Vigilance Guidance

The EU Commission have released revision 8 of MEDDEV 2.12-1: Guidelines on a Medical Device Vigilance System. The updated version includes guidelines for In Vitro Fertilisation (IVF)/Assistive Reproductive Therapies (ART) devices, in addition to medical devices.  The guidance remains for the most part unchanged, however the inclusion of IVF/ART devices results in changes to the incident reporting criteria for manufacturers. The guidance also explores the difficult task of defining indirect harm and serious deterioration of patient health for IVF/ART device manufacturers.

MEDDEV 2.12-1, revision 8 is applicable from July 2013.

Ensure your organisation’s EU post market procedures comply with the updated guidance, obtain a copy of MEDDEV 2.12.1 revision 8 (go to guidelines). Alternatively, visit our Post Market Surveillance page for information on how KD&A can assist you.