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 Guidance on Period Safety Update Report (PSUR) under MDR
Manufacturers of class IIa, class IIb, and class III medical devices have to prepare a Period Safety Update Report (PSUR) for each device or group…
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…
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 and PMPF (Post Market Performance Follow-up) study notification. Documents for…
MDCG Position Paper on extension period for legacy devices
The previous 2024 deadline worried the medical devices sector. With foreseeable market disruptions and negative consequences for health systems and patients, the Council found new…
New extensions to implement MDR: impact on legacy devices
The new Regulation on Medical Devices (MDR) entered into force in May 2021, replacing the previous Directive. Since then, many medical devices are subject to…
MDR: 36 Notified Bodies on NANDO
The NANDO database newly listed 36 Notified Bodies under the MDR! ICIM S.P.A. has been the latest NB notified under the Regulation (EU) 2017/745 on…
MDCG Position Paper on Hybrid Audits
Implemented during the pandemic and helped by new technologies, hybrid audits have become more frequent. A hybrid audit is an audit conducted on site and…