Conformity assessment involving notified body
A notified body performs conformity assessments, i.e., assessing whether a product complies with the requirements of the regulations.
What is a notified body?
A notified body is an independent third party whose task is to assess whether medical devices and in vitro diagnostic (IVD) medical devices meet the requirements of the regulations. The authorities designate a notified body, and there are strict requirements for the notified bodies' competence and independence.
During the conformity assessment, the notified body assesses the manufacturer's technical and clinical documentation and, among other things, the manufacturer's quality management system. If the manufacturer's documentation complies with the requirements, the notified body shall issue a certificate. The manufacturer must have this certificate to affix the CE marking to the product and place it on the market. The notified body shall carry out inspections of manufacturers, both announced and unannounced.
Which classes of medical devices require conformity assessment by a notified body?
For medical devices in higher risk classes (class IIa, IIb, and III for medical devices and class B, C, and D for IVD medical devices) the product and the manufacturer's documentation must be assessed by a notified body before the device can be placed on the market.
The requirement for involvement of a notified body also applies to devices in class I that are placed on the market in sterile condition (class Is), have a measuring function (class Im) or are reusable surgical instruments (class Ir). Similarly, a notified body must be involved in the conformity assessment of class A IVD medical devices that are placed on the market in sterile condition.
Products in the lowest risk class (class I for medical devices and class A for IVD medical devices) are assessed for conformity by the manufacturer without the involvement of a notified body.
For manufacturers: How to choose a notified body
For medical devices that require the involvement of a notified body, the manufacturer must apply for a conformity assessment with a notified body that is designated for the device category to which the manufacturer's device belongs.
The device categories are stated in Regulation (EU) 2017/2185 on the list of codes and corresponding types of devices for specifying the scope of the designation as notified bodies under the new regulations.
The manufacturer is free to choose a notified body within the EU / EEA area but cannot apply for a conformity assessment of a medical device with several notified bodies at the same time.
For a transitional period, there will be notified bodies designated under the directives AIMDD, MDD and IVDD, and the new EU regulations, MDR and IVDR.
An overview of notified bodies that have been designated, and which device categories they have been designated for, can be found in the European database NANDO.
About the designation and monitoring of notified bodies
The Norwegian Medicines Agency is responsible for the designation and monitoring of notified bodies in Norway. Before designation, the notified body must be assessed for the requirements of the regulations. This assessment takes place via a joint European procedure ("joint assessment") and is carried out by an inspection team from the Norwegian Medicines Agency in collaboration with experts from the EU Commission and other member states. Notified bodies that are designated must be reassessed every four years. The Norwegian Medicines Agency conducts inspections of notified bodies on a regular basis.
The rules for designation and monitoring of notified bodies in accordance with the new EU regulations on medical devices apply from 26 November 2017.
Notified bodies designated in accordance with current directives on medical devices must be designated again in accordance with the new EU regulations.
Conformity assessment bodies who wish to apply for designation as a notified body under the new EU regulations may do so without being pre-designated in accordance with current directives on medical devices.
The rules have been included as an amendment to the regulations on medical devices (in Norwegian).