The NANDO database has a new Notified Body under the IVDR! MDC MEDICAL DEVICE CERTIFICATION GMBH is the 9th EU Notified Body notified under the…
Updated MDCG Guidance on classification rules for IVD medical devices
In February 2023, the Medical Device Coordination Group (MDCG) published a new revision of the Guidance on classification rules for IVD medical devices. The revision…
MDCG Guidance on Article 5 (5) of MDR & IVDR!
The Medical Devices Coordination Group (MDCG) has issued a guidance on Article 5(5) of the Medical Devices and In Vitro Diagnostics devices regulations. Thus, this…
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 devices, which affects legacy devices under Article 120.3 of the…
IVDR: 8th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! QMD Services GmbH. is the 8th EU Notified Body notified under the Regulation (EU)…
MDR & IVDR: Update to Manual on borderline classification!
The Medical Devices Coordination Group (MDCG) released in December 2022 a new update to their manual on borderline and classification for medical devices under MDR…
MDCG template for substantial modification of performance study
Performance evaluation data can derive from performance studies. Data generated in performance studies must be reliable and robust, as stated in the Regulation on IVD…
MDR & IVDR national implementation: Austria
The Austrian Medical Device Act 2021 implements the EU Regulations on medical devices and in vitro diagnostic medical devices in Austria. The Austrian Federal Office…
MDCG Joint Implementation plan on IVDR
In October 2022, the Medical Device Coordination Group (MDCG) released a new update to its joint plan on the preparedness and implementation of the In…
Notified Bodies: requirements, certifications, and applications
Several publications related to notified bodies marked October 2022. Among others, the Medical Device Coordination Group (MDCG) published a Q&A document on requirements relating to…