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.
Even taking into account the expected postponement of the MDR, the designation of further notified bodies under the new legislation cannot come fast enough. Out of roughly 50 notified bodies which were designated under the outgoing MDD and AIMDD, only 12 have been re-designated under the MDR so far. However, 44 applications for designation have been received, including 2 new applicants. Similarly, while 21 notified bodies were designated under the outgoing IVDD, only 3 notified bodies have been designated so far under the new In Vitro Diagnostic Regulation 2017/746 (IVDR), despite 14 applications for designation having been received, including 1 new applicant.
The lack of notified body capacity to perform conformity assessments under the new legislation is something we’ve written about previously – for more information on the concerns expressed by manufacturers trying to recertify their products under the MDR and IVDR, please click here.