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…
The UK Department for Environment, Food and Rural Affairs (DEFRA) is inviting responses to a consultation seeking views on extending the restrictions on the use of four phthalates in medical devices, monitoring and control equipment in Great Britain (GB). “We want to know what you think about a proposed restriction on the use of 4…
MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health, ran a survey in July 2021 to gather data from IVD manufacturers on the state of the IVD market today and how they are expected to transition to the IVD Regulation within ten months from the survey…
CEN has now published EN ISO 13485:2016+A11:2021, ‘Medical devices – Quality management systems – Requirements for regulatory purposes’, adding Annex Zs to the already published standard. It is expected that the European Commission will add EN ISO 13485:2016+A11:2021 to the slowly growing list of standards harmonized under the Medical Device Regulation (MDR, 2017/745) and the…
