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The Regulation represents a significant development and strengthening of the existing regulatory system.
The impact on management of IVD safety and performance will be significant, thanks to the introduction of some new requirements for all economic operators, laboratories, notified bodies and competent authorities.
The main changes introduced by Regulation (EU) 2017/746 are represented, among other things, by:
(*) a new classification of devices, which are divided into classes A, B, C and D, according to the intended use and the risks involved
(*) new conformity assessment procedures
(*) new requirements for clinical evidence, performance evaluation and performance studies
(*) new obligations for manufacturers, authorized representatives, importers and distributors
(*) the provision of the role of the Person responsible for compliance with the legislation, which manufacturers must necessarily use
(*) the UDI system, identification of a device
(*) the strengthening of supervisory and post-market surveillance activities
(*) the establishment of reference laboratories
(*) the European database Eudamed, developed by the European Commission to implement the Regulation (EU) 2017/745 on medical devices and the Regulation (EU) 2017/746 on in vitro diagnostic medical devices
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