Currently, electronic Instructions for Use (eIFUs) are only allowed for certain types of medical device, e.g.: If they are for professional use and use by other persons is not foreseeable: Implantable and active implantable devices, Fixed installed medical devices and their accessories, and Medical devices and their accessories fitted with a built-in system visually displaying…
MDCG 2019-6 has been revised and reissued as Rev.5, with changes related to ‘structured dialogue’ and ‘leveraging evidence’ being included. The main change has been to add section IV.13, ‘What is considered “Leveraging evidence”?’, which explains that: “notified bodies should avoid unnecessary duplication of work when performing their conformity assessment activities. In this respect, a…
The International Medical Device Regulators Forum (IMDRF) on has finalised two technical documents detailing guiding principles for good machine learning practices (GMLP) and risk characterization for medical device software. The final IMDRF GMLP document lists ten guiding principles for good machine learning practices. The principles include understanding the product’s intended use; implementing good software, design,…
For anyone in the medtech industry seeking up-to-date information relating to the performance of actors within the regulatory sector covering the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746), the on-line dashboard provided by the Austrian National Public Health Institute (Gesundheit Österreich GmbH/GÖG), in collaboration with Areté and Civic Consulting, commissioned…
The US Food and Drug Administration (FDA) finalized guidance to industry on allowable communications to health care providers about off-label drug and device uses. The Q&A document, issued on 6 January 2025, outlines the agency’s enforcement policy for firm-initiated communications to health care providers that contain scientific information on unapproved uses (SIUU) for approved or…
The European Commission has launched a public consultation seeking stakeholder input on the effectiveness of the EU Medical Devices Regulation (MDR, 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR, 2017/746) in a targeted evaluation. An announcement stated that the evaluation will help the Commission “take stock” and assess the effectiveness, efficiency, and proportionality…
Following the EPSCO meeting on 3 December 2024 at which the subject of MDR/IVDR reform was discussed, MedTech Europe has published its response to the out come of the meeting, available from here. In the statement, the industry association comments: “[W]e call for the swift adoption of immediate measures, and before the targeted evaluation’s conclusions….
In the light of the anticipated go-live of most of the European database on medical devices (EUDAMED) modules in 2025, MedTech Europe has summarised in a position paper its viewpoint on ensuring a smooth transition to its mandatory use, in which it calls for improved accessibility, efficiency and consistency through technical and regulatory measures in…
ECRI has issued it ‘Top Ten Health Technology Hazards Report’ for 2025, available from here. The report identifies potential sources of danger involving the use of medical devices and systems. Further, the report offers practical recommendations for reducing the identified risks, all with the goal of preventing harm. The List for 2025 is: 1. Risks…
The US Food and Drug Administration (FDA) has issued a much-anticipated final guidance document detailing how it plans to regulate changes to artificial intelligence (AI) enabled medical devices post authorization by using pre-determined change control plans (PCCPs), allowing manufacturers to update AI-enabled devices without filing an additional submission to the Agency. The document is titled…
