A Notified Body is an organization that assesses the conformity of certain products before being placed on the EU market. The conformity assessment is a process by which you demonstrate that the product complies with the requirements set out in the applicable legislation. A Notified Body is designated by an EU country and carries out third-party conformity assessment procedures including calibration, testing, certification, and inspection.
In particular, Notified Bodies relating to medical devices verify that the requirements of the specific legislation for a device are fulfilled.
Difference between “Directive” and “Regulation”
The legal difference between “Directive” and “Regulation” is that a “Directive” is a legislative act setting objectives that all EU countries must reach and translate into their national legislation within a defined time frame. However, it is up to the individual states to determine how to achieve these goals by implementing them in their local laws. As a consequence, a Directive may be enforced in different manners in the EU Member States. A “Regulation” is defined as a binding legislative act. It is immediately applicable in its entirety in all Member States, and it overrules national laws.
EU In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR)
The new Regulation came into force in 2017, with a 5-year implementation period, until the 26th of May 2022, when the Regulation would replace the Directives.
The IVDR replaces the EU’s current Directive on In Vitro Diagnostic Medical Device (IVDD) (98/79/EC) to ostensibly ensure a higher level of health and safety for making available and putting into service devices in the EU market and setting new rules for applying a CE mark to IVDs.
The EU IVDR affects all IVD medical devices and will bring about several changes. Manufacturers are reviewing their product portfolio, and Health Institutions should be aware of which of their products will be affected and prepare ahead to ensure continuity after the IVDR date of application.
There are specific Notified Bodies dedicated to performing the conformity assessment of in vitro diagnostic medical devices. Here we show you the list of Notified Bodies that currently have received their designation under this Regulation.