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Useful, absent, useless or simply not up to modern communication and information exchange practices, finally I’ve just seen an honest debate on the thorny subject of instructions for use for medical devices. It seems that the seeds are being sown in the garden of England for future change to the benefit of everyone.

There are some who are claiming that the EU Commission’s formal objection to eleven standards raised at the end of last year shows that the ‘New Approach’ has shortcomings and that the whole system is ripe for overhaul. I would argue far from it. The New Approach is a very clever system of product regulation, […]

Talking about ethics and compliance as industry understands it within the frame of a course of Health Systems Management given at the Public Health School of the Université Libre de Bruxelles (ULB) presented itself as a challenge. On the one hand, Eucomed is putting a lot of efforts into promoting a culture of integrity and […]

In an ideal world we would have the same rules on devices in each country.  As patients, as we live or travel in different countries, we can be confident that should we fall ill, the devices used to help us are as safe as the ones at home.  As businesses, we would be confident that […]