The Medical Device Coordination Group (MDCG) issued two additional guidance documents in December 2019. The “Explanatory notes on MDR codes” provide further clarification on the use of designation codes of… Read More
The Medical Device Coordination Group (MDCG) issued a guidance document to help manufacturers of class I medical devices to comply with Regulation (EU) 2017/745 on medical devices (MDR). It gives… Read More
The Medical Device Coordination Group (MDCG) has recently published a useful guidance on the “Person Responsible for Regulatory Compliance” (PRRC) according to article 15 of the MDR and IVDR. There… Read More
The Medical Device Coordination Group (MDCG) has recently published a useful guidance on the Implant Card (IC) according to article 18 of the MDR. It makes sense to review the… Read More
The Medical Devices Coordination Group (MDCG) has published a number of guidance documents on the topic of UDI over the past months. More recently, the MDCG issued guiding principles for… Read More
The European Commission’s Medical Devices Coordination Group (MDCG) recently published two guidance documents on timelines for device registration and on registration expectations for manufacturers of legacy devices. Legacy devices in… Read More
The Medical Device Coordination Group (MDCG) has published a guidance document on the interpretation of article 54(2)b of the MDR. The aforementioned article provides criteria for the exemption of medical… Read More
