The Medical Devices Coordination Group (MDCG) has issued a guidance on Article 5(5) of the…
Legacy devices: European Commission adopts proposal to extend Transitional period & Certificates!
The European Commission has adopted a new proposal to give more time to certify medical…
IVDR: 8th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! QMD Services GmbH. is…
MDR & IVDR: Update to Manual on borderline classification!
The Medical Devices Coordination Group (MDCG) released in December 2022 a new update to their…
MDCG template for substantial modification of performance study
Performance evaluation data can derive from performance studies. Data generated in performance studies must be…
MDR & IVDR national implementation: Austria
The Austrian Medical Device Act 2021 implements the EU Regulations on medical devices and in…
MDCG Joint Implementation plan on IVDR
In October 2022, the Medical Device Coordination Group (MDCG) released a new update to its…
Notified Bodies: requirements, certifications, and applications
Several publications related to notified bodies marked October 2022. Among others, the Medical Device Coordination…
Updated EC Implementation Rolling Plan (MDR/IVDR)
The European Commission released an updated Implementation Rolling Plan under the Regulations 2017/745 and 2017/746…
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…