In order to help medical devices manufacturer in their obligations regarding vigilance, the European Commission published a guidance to complement the current guidelines on medical devices vigilance system, MEDDEV 2.12-1 rev 8, 2013. Read more “European Commission issues additional guidance on device vigilance system”
Category: Medical device
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”
EU Medical Device Coordination Group releases Eudamed guidance
The European Union (EU) Medical Device Coordination Group (MDCG) have released two new documents outlining how legacy devices can be registered in Eudamed without a unique device identifier (UDI) and how device companies have until November 2021 to register device data elements in Eudamed. Read more “EU Medical Device Coordination Group releases Eudamed guidance”
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”
FDA delays enforcement dates for class I and unclassified device UDIs by two years
The Food and Drug Administration (FDA) has released new guidance which pushes back the date by which the FDA will enforce certain unique device identifier (UDI) requirements for class I and unclassified devices by two years. Read more “FDA delays enforcement dates for class I and unclassified device UDIs by two years”
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 launches Special 510(k) Program Pilot
Following the release of draft guidance that proposed expanding the device changes that would be eligible for the special 510(k) program, the Food and Drug Administration (FDA) has launched a pilot to put the planned changes into use. Read more “FDA launches Special 510(k) Program Pilot”
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”