Italy has added another notified body (NB) to those now designated to operate under the EU Medical Devices Regulation (MDR, 2017/745), making a total of 24 available for use by device manufacturers, according to the NANDO website. Milan-based Certiquality, NB reference number 0546, is the latest to be added to the list of NBs designated…
The EU Commission has proposed an amendment to the transition of the In Vitro Diagnostic Regulation (IVDR, 2017/746) according to a press release and an accompanying Q&A webpage. In summary, the Commission has proposed that higher risk devices such as HIV or hepatitis tests (class D) and certain influenza tests (class C), have a transition…
The EC Medical Device Coordination Group (MDCG) has now published its guidance reference MDCG 2021-24, ‘Guidance on classification of medical devices’, to help manufacturers of devices regulated by the Medical Device Regulation (MDR, 2017/745) reach the correct conclusion about specific devices. The guidance follows the same format used for the preceding guidance relating to the…
The US Food and Drug Administration has now published its final rule on the de novo pathway for medical device clearance, clarifying the requirements for manufacturers whose devices may need to use the route in future. The 84-page final rule includes only minor changes from the 2018 draft rule. The pathway is used by manufacturers…
According to the Eudamed webpage, a significant upgrade will be installed over the period from 30 September and 4 October 2021, and users are advised not to try and access the system during this time, but to wait until a confirmation of upgrade completeness is published on the same webpage. The notice warns that the…
To allow consultation among competent authorities (CAs) on borderline and classification issues concerning medical devices, and to ensure that appropriate guidance is published in the Manual on Borderline & Classification for Medical Devices (the Manual), the Borderline & Classification Working Group (BCWG) of the Medical Devices Coordination Group (MDCG) has updated the ‘Helsinki Procedure’ first…
The European Commission has published the September 2021 copy of its Newsletter for Medical Devices, copy obtainable from here. The Newsletter covers, among other topics: A webinar for patients Launch of a UDI Helpdesk Transitional provisions for IVD certification Q&A for specific combinations of medicinal products and medical devices Rules for Eudamed registration Identification numbers…
The UK government, via the Medicines and Healthcare products Regulatory Agency (MHRA) has now published its consultation on the future regulation of medical devices in the UK. The MHRA webpage introducing the consultation is available from here, and the consultation questionnaire itself is accessible here. As background, the current 2021 version of the 2002 device…
