Sweden Issues Guidance on Notified Bodies

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:

• Active implantable devices;
• Active non-implantable devices for imaging, monitoring and/or diagnosis;
• Active non-implantable therapeutic devices and general active non-implantable devices;
• Non-active implants and long-term surgically invasive devices;
• Non-active non-implantable devices; and
• Technologies for medical devices.

The draft list of codes and types of devices for in vitro diagnostic devices includes IVDs intended to be used for:

• Blood groups;
• Tissue typing;
• Cancer markers;
• Human genetic testing;
• Determining markers of infectious diseases and immune status;
• Screening or confirming a specific disease;
• Defining or monitoring physiological status and therapeutic measures;
• Quantitative or qualitative assigned values; and
• Sterile laboratory and clinical uses and IVDR manufacturing technologies.

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).

Read the Medical Products Agency notice here: www.fdanews.com/08-15-17-Swedennotifiedbodies.pdf.