Fimea designates the first notified body under the IVD Regulation in Finland

Fimea has appointed Eurofins Electric & Electronics Finland Oy as a notified body in accordance with the Regulation on In vitro Diagnostic Medical Devices (2017/746, IVD Regulation). Notified bodies are independent third-party assessment bodies carrying out conformity assessments under the Regulation.

To date, only ten notified bodies under the IVD Regulation have been designated throughout the EU.  The designation was published on the European Commission website in the Nando database on 16 September 2023.

In vitro diagnostic (IVD) medical devices include for example various laboratory or home tests, or sample tubes used to examine human samples to diagnose a disease or monitor treatment. For example, coronavirus home tests or tests and analysers used in healthcare to measure blood sugar, cholesterol or cancer markers are IVD devices.   

Before placing an IVD device on the market, the manufacturer must ensure that the device meets the relevant safety and performance requirements. Medical devices, including IVDs, must be CE marked before they are placed on the market. With the CE marking, the manufacturer demonstrates that the device meets the requirements of the relevant European Union legislation and is effective and safe. With the entry into force of the IVD Regulation, the risk classification of IVDs changed significantly, and many more IVDs now require the involvement of a notified body in the assessment procedure.

In order to act as a notified body under the Regulation, the designation must be applied for from the national authority. In Finland, notified bodies for medical devices and in vitro diagnostic medical devices are designated and supervised by the Finnish Medicines Agency Fimea. Fimea actively participates in cooperation between European authorities in the evaluation and supervision of notified bodies.

The process of designating a notified body is demanding and lengthy. The designation is always preceded by a detailed assessment of the application and supporting documentation, a week-long joint assessment by the EU Commission, two national experts from other member states and the national designating authority at the applicant's premises, and an approval of the Medical Device Coordination Group (MDCG) formed by the Commission and the authorities of the member states.

The manufacturer of a medical device is free to use any European notified body with a suitable area of competence. Notified bodies appointed in Finland serve not only domestic customers but also international customers.

Read more:

New EU Regulation on in vitro diagnostic medical devices comes into force on 26 May 2022 (in Finnish)

NANDO (New Approach Notified and Designated Organisations) Information System