The Notified Body represents a conformity (compliance) assessment body, designated in Brussels by a National Designating Authority and then notified to the European Commission and the other Member States, in accordance with Regulation (EU) 2017/745 on medical devices, hereinafter referred to as the MDR, and in accordance with Regulation (EU) 2017/746 on in vitro diagnostic medical devices, hereinafter referred to as the IVDR.

A Conformity Assessment Body is a body which performs conformity assessment activities as a third-party, including calibration, testing, certification and inspection.

For some categories of medical devices or in vitro diagnostic medical devices, the conformity assessment procedure requires the involvement of a MDR designated notified body and a IVDR designated notified body, provided that the Notified body chosen by the manufacturer is designated to carry out the conformity assessment activities regarding the types of devices in question.

According to the MDR, medical devices which require the involvement of a Notified Body for being placed on the market are those belonging to classes III, IIb, IIa, sterile condition (Is), with a measuring function (Im) and reusable surgical instruments (Ir).

For devices of classes Is, Im and Ir, the intervention of the Notified Body is limited to aspects related to: establishing, ensuring and maintaining the sterile condition (Is), device compliance with metrological requirements (Im) and reuse of the device, particularly cleaning, disinfection, sterilisation, maintenance and functional testing and related instructions for use (Ir).

The above-mentioned medical devices will bear the CE marking accompanied by a 4-digit number, which represents the identification number of the Notified Body involved in the conformity assessment procedure.

According to the IVDR, in vitro diagnostic medical devices that require the involvement of a Notified Body for placing on the market are those in classes D, C and B, including those for self-testing and testing in the proximity of the patient, companion diagnostic devices, as well as class A in vitro diagnostic devices placed on the market sterile.

For class A in vitro diagnostic medical devices placed on the market in a sterile condition, the involvement of the notified body is limited to aspects related to establishing, ensuring and maintaining the sterile condition.

The in vitro diagnostic medical devices mentioned above will bear the CE marking accompanied by a 4-digit number, which represents the identification number of the Notified Body involved in the conformity assessment procedure.

Both manufacturers of medical devices or in vitro diagnostic medical devices which require the involvement of a Notified Body in order to place the devices they manufacture on the market, as well as any other parties interested in this information, can consult the list of MDR-designated Notified Bodies and IVDR-designated Notified Bodies by accessing the link below, which leads to the European Commission’s website where both Notified Bodies based in one of the EU Member States and Notified Bodies based in one of the EFTA countries (EEA members) and in other countries with which the EU has concluded mutual recognition agreements (MRA) and protocols to the European agreements on conformity assessment and acceptance of industrial products (PECA) can be found:

https://webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies

NOTE:

1. Please note that the List of MDR designated notified bodies and IVDR designated notified bodies is constantly updated.

2. Currently, Romania does not have a MDR designated notified body or a IVDR designated notified body in Brussels.

Conformity Assessment Bodies that wish to request the NAMMDR, as Designating Authority in Romania, to be designated in Brussels as MDR designated notified body or IVDR designated notified body, must provide proof of compliance with the provisions of the applicable legislation in force and submit the relevant documentation to the NAMMDR.

Applicable legislation:

ORDER No. 3.277 of 22 September 2023 on amendment of Order of the Minister of Health no. 3.969/2022 on approval of the Methodological Rules for assessment, designation and notification of the bodies assessing medical device compliance, as well as for monitoring and reassessment of notified bodies