Europe – Organismes Notifiés et RDM : le point à date

Just in time for the European Commission to announce that it intends to postpone the date of application of the Medical Device Regulation 2017/745 (MDR) by 12 months to until 26 May 2021, Hungary’s CE Certiso Orvos-és Kórháztechnikai Ellenőrző és Tanúsító Kft. has been designated as the 12th notified body under the MDR.

CE Certiso Orvos-és Kórháztechnikai Ellenőrző és Tanúsító Kft, which roughly translates from Hungarian as “CE Certiso Medical and Hospital Inspection and Certification Ltd.”, joins bodies including BSI and TÜV SÜD in being authorised to perform conformity assessments on devices regulated by the MDR.

CE Certiso also remains a designated notified body for the purposes of the outgoing Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMDD) and In Vitro Diagnostics Directive (IVDD).

According to an update published by the European Commission on 18 March, CE Certiso should be closely followed by two more bodies who have obtained a recommendation from the Medical Device Coordination Group, and so are in the final stages of being designated as notified bodies under the MDR…