Sweden’s Medical Products Agency issued guidance on the new EU procedures for appointing a notified body that will go into effect on Nov. 26. The agency promised to issue further updates when there’s “more clarity around notified bodies in the EU.”
The agency flagged three documents released by the EU’s Notified Body Operations Group (NBOG), including a draft list of documents to be submitted in an application for designation as a notified body, and a list of codes and types of devices to specify the scope of a notified body designation for medical devices and for IVDs.
The NBOG recently posted separate application forms on its website for submissions by conformity assessment bodies applying for designation as a notified body under the medical devices Regulation (MDR) or under the in vitro diagnostic devices regulation (IVDR).
The draft list of documents includes general and organizational requirements, quality management requirements, resource requirements, and process requirements for the proposed notified body.
The draft list of codes and types of devices for notified body designation for medical devices includes:
The draft list of codes and types of devices for in vitro diagnostic devices includes IVDs intended to be used for:
As part of the EU regulatory overhaul, all notified bodies will be re-designated and required to have documented procedures regarding unannounced on-site audits of manufacturers and, when applicable, subcontractors and suppliers.
Notified bodies will also notify competent authorities when they grant certificates for high-risk devices, and the authorities may request additional information from notified bodies (IDDM, May 12).