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”
Category: Medical device
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”
FDA proposes electronic submission for medical device market applicants
The US Food and Drug Administration (FDA) intends to remove requirements for paper and multiple copies of medical device premarket applications, and replace it with a single submission in electronic format. The new proposed rule would apply to: 510(k) premarket notifications; Investigational Device Exemptions (IDE); Premarket Approvals (PMA) applications and supplements; Humanitarian Device Exemptions (HDE) and applications to the Center for Biologics Evaluation and Research (CBER). Read more “FDA proposes electronic submission for medical device market applicants”
Health Canada launches pilot project on new meeting framework for pre-clinical advice on devices
Health Canada has launched a pilot project which aims to provide a new formal process for device companies seeking early advice. A formal pre-clinical process will allow manufacturers to discuss regulatory evidence requirements and investigational testing protocol design with Health Canada early in the device development process. The aim is to facilitate effective communication between medical device manufacturers and Health Canada to improve the quality of submissions and provide timely regulatory decisions. Read more “Health Canada launches pilot project on new meeting framework for pre-clinical advice on devices”