Fifty Up! Hungary designates the latest Notified Body

The EU now has its 50th Notified Body under the Medical Device Regulations, NEOEMKI in Hungary, following the designation of the 49th, the Istituto Superiore di Sanita (ISS) in Italy being designated under the IVDR in September.

NEOEMKI (Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság), based in Budapest, is the second designated under the MDR in Hungary, and was previously designated under the Medical Device Directives for both general devices and IVDs.

NEOEMKI has been designated for a number of active and non-active device areas, the full list of which can be viewed on the NANDO website.