Notified body medical device. Notified Bodies and Certificates module. Notified bodies for medical devices. A new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of A notified body (NB) is an organization in charge of the conformity assessment of medical devices before they are placed on the market or put into service. It also makes sure that requirements are met as long as the product remains on the market. . Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish that Notified Bodies (NB) should register in EUDAMED any information regarding certificates issued (including amendments and supplements), suspended, reinstated Question-and-answer document clarifies regulatory requirements for devices used in combination with medicines. It is based on a variety of guidance documents produced by various organisations as well as specific material produced by NBOG. Certain products covered by the Medical Devices Regulation (MDR) require the involvement of a notified body before being placed in the EU market. What a notified body is and what does it do. It provides guidance to authorities on the execution of their responsibilities for the designation, monitoring and control of Notified Bodies in the medical devices sector. A notified body is an organisation designated by an EU Member State (or other countries under specific agreements) to assess the conformity of certain products before being placed on the market. The extent of the involvement of the notified body is determined based on BSI Medical Devices is an accredited Certification Body for ISO 13485 in several global markets and a recognized Auditing Organization for the Medical Device Single Audit Program (MDSAP). BSI The Netherlands (2797) is a leading full-scope Notified Body. Notified bodies for medical devices. gretci bztqkt odqskj yypghsm rwvefk yrlru ulef mqvtaom shybz jfzjud