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…
Conformity assessment: Annual report on Clinical Evaluation Consultation Procedures (CECP)
According to Article 54 of the Medical Devices Regulation (MDR), Notified Bodies have to follow a Clinical Evaluation Consultation Procedure (CECP) when performing a conformity…
MDR: 37th Notified Body on NANDO!
The NANDO database has a new Notified Body under the MDR! SLG PRÜF UND ZERTIFIZIERUNGS GMBH is the 37th EU Notified Body under the Regulation…
Notified Body: templates for Lists of Standard Fees
Notified Bodies assist manufacturers in the conformity assessment of certain medical devices before being placed on the EU market. According to Article 50 of the…
How MDCG 2022-18 applies in Switzerland: certification gaps and notification
Following the Council’s agreement on the new measures to implement the Medical Devices Regulation (MDR), the Medical Device Coordination Group (MDCG) published a position paper…
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 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…