New IVD Guidelines - Supply of Instructions for Use!!!!!
To the clients of MDSS
Annex I, section 8.1 of the In Vitro Diagnostic Medical Device Directive 98/79/EC requires manufacturers to supply the information necessary for the safe and proper use of the device. However, the Directive does not specify in what form. Currently most instructions for use (IFU) are provided in paper format. These documents can be very lengthy due to the need to include multiple printed versions in all the required languages. The cost to the manufacturer and the environment the can also be high.
For this reason, guidelines on issuing IFU to professional users in a format other than paper have been addressed in a recently published MEDDEV document, 2.14/3 rev. 1. While not legally binding, the guideline was jointly drafted by various parties including Competent Authorities. The guidelines can be downloaded from the following address:
MDSS is confident the document will be of interest to our IVD clients, but please read in association with the labeling and language requirements of the IVD Directive.
Please note, the above guidelines do not apply to medical devices. The current version of Medical Device Directive states that information needed to use the device safely must be set out on the device itself and / or on the packaging for each unit or where appropriate, on the sales packaging. If the individual packaging of each unit is not practicable, the information must be set out in the leaflet supplies with the device. Consequently, this limits providing IFU in the form of printed sheets. Hopefully, the new version of the MD Directive to be published in the new future will take this matter into consideration.
If you have any questions, please do not hesitate to contact us.
Your MDSS Team
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