ISO 20417:2021 "Medical devices - Information to be supplied by the manufacturer" which was just published, but not through a joint process in Europe through CEN, has an Informative Annex B - Example test method for assessing clearly legible requirements. You could consider these test requirements as "State of the Art" requirements as there are no Harmonized Standards that exist or that will exist in the near or long term as I have said in many of my posts in this
forum and
LinkedIn. These requirements are based on IEC 60601-1, Ed. 3.0, 3.1 & 3.2 legibility requirements from clause 7.1.2 which are very similar but not identical.
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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email:
Leo@EisnerSafety.comWebsite:
www.EisnerSafety.com------------------------------
Original Message:
Sent: 23-Apr-2021 18:32
From: Anonymous Member
Subject: Legibility requirements for label : EU-MDR (devices)
This message was posted by a user wishing to remain anonymous
Hello,
I am interested to know how others are claiming compliance with the legibility requirments under EU-MDR? Is there any tool or website you recommend to confirm the legibility of the label artworks? I am interested to hear your thoughts on the legibility requirements.
11.Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.
Thank you in advance.