The NANDO database has a new Notified Body under the MDR! SZUTEST Konformitätsbewertungsstelle GmbH is…
Conformity assessment: Annual report on Clinical Evaluation Consultation Procedures (CECP)
According to Article 54 of the Medical Devices Regulation (MDR), Notified Bodies have to follow…
MDR: 37th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! SLG PRÜF UND ZERTIFIZIERUNGS…
Notified Body: templates for Lists of Standard Fees
Notified Bodies assist manufacturers in the conformity assessment of certain medical devices before being placed…
MDCG Position Paper on Hybrid Audits
Implemented during the pandemic and helped by new technologies, hybrid audits have become more frequent.…
Notified Bodies: requirements, certifications, and applications
Several publications related to notified bodies marked October 2022. Among others, the Medical Device Coordination…
NB Position Papers on Class D devices in absence of EURLs and time to implement guidance documents
Between September and October 2022, Team-NB published various position papers. One of them addresses class…
NB Position Paper: What are Hybrid Audits and how to perform them?
In September 2022, Team-NB published a position paper on hybrid audits for quality management system…
Team-NB: Notified body approach for multiplex IVDs
Team-NB, the European Association of Medical Devices of Notified Bodies, published a position paper on…