The Central Management Committee (CMC) informed COCIR and other stakeholders on their <media 244>statement</media> to improve the readability of instructions for use (IfU) in the context of the Medical Devices Directives.

The CMC is encouraging additional measures, i.e. concerning quality of translations and understandability of texts and graphics, appropriate font sizes to be used, and checks to be performed by Notified Bodies on the readability of IFU.

COCIR welcomes this statement and agree that readability of instructions for use is an important aspect of patient and operator safety, which both are high priorities to our members.

At present, the European legal framework for IfU of medical equipment largely covered by MDD Essential Requirements 2, 13.1, and 13.6, appear in our opinion adequate when combined with European harmonized standards. European harmonized standards, although voluntary, are important elements supporting the European Directives on Medical Devices.

Readability of IfU is also addressed through the following European harmonized standards which are used by our members:

1. EN 60601-1 (Ed.3) clause 7.9 and its reference to EN 62079:2001 “Preparation of instructions - Structuring, content and preparation”, and its successor EN 82079-1:2012 “Preparation of instructions for use - Structuring, content and presentation - Part 1: General principles and detailed requirements”, which explicitly address the readability in their clause 6.2.
2. EN 62366 “Application of usability engineering to medical devices”.
3. EN 14971 “Application of risk management to medical devices”.

COCIR supports the fact that proper and consistent application of the current legal provisions is required.