European Commission releases safety and performance requirements for reprocessing single-use medical devices under the MDR

The European Commission (EC) has outlined the common specifications for the reprocessing of single-use medical devices under the European Union’s (EU’s) medical device regulation (MDR). The common specifications have been issued via a draft implementing regulation in alignment with criteria in Article 17(3) of the MDR. Read more “European Commission releases safety and performance requirements for reprocessing single-use medical devices under the MDR”

EMA opens consultation on draft guideline on quality requirements for medical devices in combination products

The European Medicines Agency (EMA) has opened a consultation on a draft guideline on quality requirements for medical devices in human medicines that include a medical device, which are known as drug-device combination products. The draft guideline is open for consultation until 31st August 2019 and is part of a series of guidance documents related to the European Union’s (EU’s) medical device regulation (MDR). Read more “EMA opens consultation on draft guideline on quality requirements for medical devices in combination products”

European Commission releases information on what UDI information to provide for Eudamed as part of the MDR and IVDR

The European Commission have released three guidance documents, which include two on the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) and the data from the unique device identifier (UDI) which needs to be included in the Eudamed database of devices and IVDs. The third document concerns the Eudamed device data dictionary. Read more “European Commission releases information on what UDI information to provide for Eudamed as part of the MDR and IVDR”

FDA starts taking steps towards a new, tailored regulatory framework for artificial intelligence-based medical devices

The Food and Drug Administration (FDA) have released a discussion paper on their proposed regulatory framework for artificial intelligence-based medical devices. The FDA consultation is open until 3rd June 2019. Read more “FDA starts taking steps towards a new, tailored regulatory framework for artificial intelligence-based medical devices”

EMA publishes first series of EU MDR/IVDR guidance

The European Medicines Agency (EMA) has published the first of a series of guidance documents to help applicants prepare for the implementation of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). The involvement of a Notified Body (NB) in a medicinal product with an integral medical device is the focus of the first EMA guidance related to the new European Union (EU) MDR. Read more “EMA publishes first series of EU MDR/IVDR guidance”