Survey of EU notified bodies shows backlog of device applications still growing - BioWorld Online

The occupation with notified assemblage (NB) capableness successful the European Union is good known, but a caller survey of NBs suggests that much than 17,000 certificates for aesculapian devices and progressive implanted devices issued nether the bequest regularisation are acceptable to expire by the extremity of 2024. More troubling mightiness beryllium the information that the fig of lasting applications dwarfs the fig of completed applications by a ratio of much than 4 to one, a spread that continues to turn arsenic calendar twelvemonth 2022 unwinds.

BioWorld MedTech Regulatory