Software in Medical Devices, by MD101 Consulting

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EU Guidances - What's new?

A few words about guidances in Europe. News are rare enough to point them out.
First, the guidance on electronic labelling came into force on 1st march 2013, see the MHRA website for some explanations and the original decision on the EU website.

Second, the guidance on vigilance and field safety notifications. The last version of this guidance aka MEDDEV 2.12-1 was released by the EU. It will come into force in july 2013.
This the revision 8 of this guidance. Height revisions! It proves that the vigilance management is a concern of EU authorities and that the system is obviously perfectible.

The change visible is in the title of section 3.1.2 in the document. For manufacturers of IVD, was replaced by For manufacturers of devices that are not intended to act directly on the individual.
The guidance adds two new types of products in its sight: in vitro fertilisation (IVF) and assisted reproduction technology (ART). It also namely adds software qualified as medical devices in its sight. Hence standalone software can be the cause of indirect harm to patients.
By extension, software that are accessories to IVD, IVF, and ART, also are in the sight of this guidance.

Section 4.6 of the document defines what a field safety corrective action (FSCA) is. It's interesting to notice that the notes under the definition add a few informations about software. These informations were not present in the last version of the guidance. A proof that software becomes a truly visible cause of incidents.


1. On Wednesday, 19 July 2017, 04:40 by Clara

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