Medical Devices and In Vitro Diagnostics Regulations: Key points for consumers

From basic care to life-saving treatments, around two million different types of medical devices shape patient and consumers’ daily lives worldwide. The revision of the EU legislative framework in 2017 was a necessary step to enhance patient safety after past scandals across Europe like faulty breast implants illustrated that weak rules put consumers at real risk. Despite some enhanced coordination efforts between national authorities, the European Commission’s current proposal to amend these rules risks reversing previous patient safety gains by simplifying rules too far.

Read our position paper.