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
BfArM, the German Federal Institute for Drugs and Medical Devices, recently published a warning notice for patients, users and manufacturers of stents and balloons that are coated with Paclitaxel. A… Read More
The UK Notified Body Lloyds Register (LRQA) announced that it will not apply for designation under the medical devices and IVD regulations (MDR and IVDR). The announcement comes at a… Read More
Only several months before the Regulation (EU) 2017/745 on medical devices (MDR) fully applies it is time for positive aspects: The MDR contains constructive guidance in many crucial aspects, one… Read More
The long overdue guidance on quality expectations for regulatory filings in the EU concerning integral and other kinds of drug-device combination (DDC) is available in draft form for public consultation.… Read More
Spain’s only Notified Body, based at the Spanish Agency of Medicines and Medical Products (AEMPS) regulatory agency, which is designated under the EU Medical Devices Directive (MDD) and In Vitro… Read More
