Croatian national laws implementing the Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostics…
New Timeline for MDCG Guidance Documents for 2023
The European Commission Directorate-General for Health and Food Safety has released the updated document on…
Team-NB guidance on submission of technical documentation under IVDR
Team-NB has released a new position paper on the best practice guidance for submitting technical documentation…
IVDR: 10th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! National Standards Authority of…
IVDR: 9th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! MDC MEDICAL DEVICE CERTIFICATION…
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…
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…
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…