Since May 26, 2021, the medical device sector experienced a great change. The new Regulation replaced the previous Directive and from that date, manufacturers of…
MDR: 28 Notified Bodies on NANDO
The NANDO database newly listed 28 Notified Bodies under the MDR! SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY – SI has been the latest NB notified…
Legacy devices: new MDCG guidance on NB surveillance & QMS
The Medical Device Coordination Group (MDCG) has published an important guidance establishing the activities to be performed by notified bodies while carrying out their surveillance…