30.01.2012 – European Commission publishes several new guidance documents

30.01.2012 – European Commission publishes several new guidance documents

The European Commission has recently published several new guidance documents in the MEDDEV series following adoption at the last Medical Device Experts Group (MDEG) meeting between member states.

The documents are:

MEDDEV 2.1/6 – Qualification and Classification of stand alone software

MEDDEV 2.2/4 – Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products

MEDDEV 2.14/1 rev.2 – IVD Borderline and Classification issues. A guide for manufacturers and notified bodies

MEDDEV 2.14/4 – CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP