Definition of the medical device according to the MDD Directive 93/42 and product classification and definition of the medical device according to the Regulation MDR 745/2017 and additions of product categories.
Product Certification Regulation
The EU MDR Regulation 2017/745 on medical devices was entered into force on May 26, 2021. The article 120 of the MDR provides specific transitional provisions in relation to medical devices that are still placed on the market in accordance with the Medical Device Directive (MDD) 93/42/EEC (Legacy devices)
Divisions of Assessment and Certification of Medical Devices
