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”

European Commission releases guidance on UDIs

The European Commission has released five new guidance documents on the use of unique device identifiers (UDIs). The guidance covers UDIs for systems and procedure packs, definitions and descriptions of formats of the UDI core elements for systems and procedure packs, UDI assignment to medical device software, clarification of UDI responsibilities in relation to Article 16, and provisional considerations regarding language issues associated with the UDI database. Read more “European Commission releases guidance on UDIs”

FDA finalises guidance on benefit-risk factors for 510(k)s

The United States (US) Food and Drug Administration (FDA) has finalised guidance on evaluating the benefit-risk profile of medical devices submitted under the 510(k) pathway that have the same indication as their predicate devices but have different technological characteristics and benefit-risk profiles. Read more “FDA finalises guidance on benefit-risk factors for 510(k)s”