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The Medical Devices Regulation (2017/745 EU) entered into force in 2017 with rules being applicable after a transitional period ending in spring 2020. The new regulation contains a series of important improvements to modernise the current system.

Information on the label of medical devices required

The MDR has new requirements that ask for various kinds of information to be indicated on the label of medical devices. To comply with this requirement in a harmonised manner, MedTech Europe has published a guidance on graphical symbols to indicate compliance with the MDR.

The symbols have been validated with users, including patients and healthcare professionals, according to international standards, and are currently being considered in the revision of ISO 15223-1 Medical Devices – Symbols to be used with medical device labels, labelling and information to be supplied.

The guidelines on graphical symbols can be found here.

Tags: Category: News
Country: EU
Disease area: Asthma,Allergy,COPD,Other diseases
Theme: - Medical Devices