Commission’s eIFU Draft Unleashes Diametrically Opposed Views Among Device Users
Industry wants to see the number of products for which electronic IFU are permitted to be expanded. But there is a strong lobby pushing for paper IFU to still be made available.
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‘JAMS’ has been strengthening the European market surveillance network and helping lower-resourced member states develop skills and capacity. Coordinated pilot project work is next.
The EU’s Competent Authorities for Medical Devices group has been meeting with the Heads of Medicines Agencies to discuss more collaborative work on borderline and combination products.
Mindful of the different information needs of patients and health care professionals when reading implant cards, the European Commission has issued new guidance.