Notified Bodies assist manufacturers in the conformity assessment of certain medical devices before being placed…
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…
MDCG template for substantial modification of performance study
Performance evaluation data can derive from performance studies. Data generated in performance studies must be…
MDCG templates for performance study application and PMPF study notification
In December 2022, the Medical Device Coordination Group published various templates on performance study application…
MDCG Position Paper on Hybrid Audits
Implemented during the pandemic and helped by new technologies, hybrid audits have become more frequent.…
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…