• Regulatory NewsRegulatory News

    EC Issues Additional Guidance on Device Vigilance System

    While highlighting an updated version of the manufacturer incident report (MIR) form that will become mandatory in January 2020, the European Commission (EC) issued guidance Tuesday on the medical device vigilance system under the EU’s medical device directive.   The January version of the MIR introduces the use of the adverse event terminology/coding harmonized via the International Medical Device Regulators Forum (IMDRF) and the use of unique device identification (U...
  • Regulatory NewsRegulatory News

    Live Case Presentations of Investigational Devices: FDA Finalizes Guidance

    The final guidance issued on Wednesday establishes new recommendations and considerations for a live or pre-recorded broadcast of a surgical or percutaneous procedure under an investigational device exemption (IDE).   The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) provides recommendations with regard to human subject protection measures and what to include in an IDE application for sponsors seeking to conduct these broadca...
  • Regulatory NewsRegulatory News

    AdvaMed Calls for Tweaks to FDA Draft Guidance on Inspections

    In two comments submitted to US Food and Drug Administration (FDA) draft guidance on inspections of medical device establishments, AdvaMed recommended several changes.   The draft guidance, issued in March, seeks to make the processes and standards for FDA inspections of device establishments uniform, per the criteria set forth under the FDA Reauthorization Act of 2017 (FDARA). Yet AdvaMed argues the draft guidance fails to deliver.   “The current wording of th...
  • Regulatory NewsRegulatory News

    EU MDR/IVDR: EC Calls for Observers to Sit on Nomenclature Subgroup

    The European Commission (EC) issued a call for applications to serve on a subgroup that will assist and advise on nomenclature-related issues, including unique device identification (UDI) and surveillance, as part of the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR).   The 5 July call gives industry associations and other health professionals or stakeholders until 5 August to submit applications. The EC’s Directorate-General for Internal Market, ...
  • Regulatory NewsRegulatory News

    WHO Updates Lists of Essential Medicines, Diagnostics

    The World Health Organization (WHO) on Tuesday released the latest lists of essential medicines and essential in vitro diagnostic (IVD) tests, which can help countries prioritize critical health products.   The updated essential medicines list (EML) adds 51 new medicines, bringing the total to 460 medicines. The updated essential diagnostics list (EDL) adds 115 tests to the 113 tests in the first EDL version , published last May.   The focus of the EML is medici...
  • Regulatory NewsRegulatory News

    France to Launch EU MDR Pilot on Clinical Investigations

    France's National Agency for the Safety of Medicines and Health Products (ANSM) will launch a pilot this fall on clinical investigations under the EU medical device regulation (MDR).   ANSM notes that MDR provisions relating to clinical investigations will result in new workflows among EU competent authorities and member states’ ethics committees. The first-of-its-kind pilot, to launch 16 September, will allow for the simulation of new working methods per MDR’s provisi...
  • Regulatory NewsRegulatory News

    UL UK to Sunset Operations Under EU’s Medical Device Directive

    UL UK says it will no longer operate as a notified body (NB) under the EU’s medical device directive (MDD) and limit its work under the in vitro diagnostic directive (IVDD).   From 1 September, UL UK will no longer operate under MDD and its current IVDD scope will become limited to a single Notified Body Operations Group code because of the implications of a no-deal Brexit.   All UK NBs are set to lose their designation status in the event of a no-deal Brexit. St...
  • Regulatory NewsRegulatory News

    Spanish NB Applies for EU MDR Designation

    The Spanish Agency of Medicines and Medical Products (AEMPS) said Wednesday it has begun the process to become designated as a notified body (NB) against the EU’s medical device regulation (MDR).   AEMPS, or NB 0318, estimates completing the EU MDR designation process during the second half of 2020. Spain’s Ministry of Health, Consumer Affairs and Social Welfare will lead the assessment process along with a team of competent authorities representing the European Commis...
  • Regulatory NewsRegulatory News

    Medtronic, J&J Back Surgical Stapler Reclassification but Raise Concerns Over New Controls

    Medtronic and Johnson & Johnson (J&J) showed support for efforts at the US Food and Drug Administration (FDA) to reclassify surgical staplers from class I to class II with some caveats, particularly as it relates to retroactively imposing new special controls on devices already in clinical use.   In response to an analysis of more than 41,000 individual medical device reports, FDA issued draft guidance in April on labeling special controls for surgical staplers and s...
  • Regulatory NewsRegulatory News

    Lawmakers Question FDA on Conditional Approvals of Devices

    In a recent letter to US Food and Drug Administration (FDA) officials, Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) opposed the idea of FDA’s using a conditional approval pathway for medical devices.   The 24 June letter questions the “progressive approval for devices” FDA described in its budget justification for Fiscal Year 2020. The senators argue that FDA’s proposal seems to expand the conditional approval pathway available for certain animal drugs to al...
  • Regulatory NewsRegulatory News

    IMDRF Releases New and Revised Documents Following March Meeting

    The International Medical Device Regulators Forum (IMDRF) posted four new final documents on unique device identification (UDI) and labeling principles, and four revised documents on IMDRF’s standard operating procedures (SOPs), the Table of Contents (ToC) format and adverse events.   Of the four new documents, three are on UDI. These include one technical document—the UDI system application guide—and two information documents on the system requirements relating to U...
  • Regulatory NewsRegulatory News

    EC Seeks Feedback on New and Revised MDR/IVDR Standards

    The European Commission (EC) has requested that the European Committee for Standardisation (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) draft revisions to existing standards and create new standards in support of the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR).   The EC’s Elżbieta Bieńkowska writes that the “harmonised standards need to be revised to take into account the requirements set out in Regulation (EU...