On 15 January 2025, the MHRA (Medicines & Healthcare products Regulatory Agency) released a new guidance on PMS requirements for medical devices following the adoption…
MDCG: Ethylene Oxide in medical devices and Borderline Classification
In October 2024, the MDCG published two documents: one on the regulatory status of ethylene oxide (EtO) used for the sterilisation of medical devices, and…
Classification of medical devices: Which legal provisions and guides to consider?
A key moment in the compliance process of products is their classification. It is the manufacturer’s sole responsibility to select the appropriate class and rule…
MDCG Q&A on MDR vigilance terms and concepts
The Medical Devices Coordination Group (MDCG) has issued new guidance clarifying important terms and concepts on vigilance stated in the Medical Devices Regulation (MDR) 2017/745.…
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…
Clinical investigations under the MDR: New Revision of MDCG on Safety reporting
The Medical Devices Coordination Group (MDCG) released on October 2022 a new revision to their MDCG guidance on safety reporting in clinical investigations of medical devices…
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…
NB Position Papers on Technical Documentation and Transfer Agreement
In October 2022, Team-NB published several position papers. The first position paper concerns the technical documentation to provide to Notified Bodies, whereas a second one…
IVD legacy devices: MDCG Guidance on appropriate surveillance
The Medical Device Coordination Group (MDCG) has issued this September 2022 new guidance on the activities to be performed by the notified bodies as part…
What is a significant change? New MDCG Guidance for IVD legacy devices
The new Regulation on in vitro medical devices (IVDR) will start to apply on May 26, 2022. For manufacturers, we want to highlight two crucial…