The US Food and Drug Administration (FDA) has published the final version of its guidance document titled ‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’, superseding the draft published in June 2018.
As in the draft, the guidance provides advice to medical device manufacturers on the following types of …
Health Canada has written to all Medical Device Licence holders and Medical Device Establishment Licence (MDEL) holders in relation to the introduction of post-market surveillance requirements that amend the Medical Devices Regulations, as published in the Canada Gazette, Part II (Vol. 154, No. 26). Health Canada explains that the changes have been made “to strengthen…
The US Food and Drug Administration (FDA) has added or updated nearly 100 voluntary consensus standards to its list of recognised standards for medical devices, available via its standards database search page. The updated standards include a number from the IEC 60601 series, including references to consolidated versions of: IEC 60601-1-2 IEC 60601-1-6 IEC 60601-1-8…
The Irish Competent Authority for medical devices, the Health Products Regulatory Agency (HPRA) has updated its guidance for medical device distributors, making it relevant to compliance with the Medical Devices Regulation (MDR, 2017/745) rather than the Medical Device Directive (MDD, 93/42/EEC). The guidance is published in ‘redline version’, so the changes from the previous version…
18 Notified Bodies are now listed on the NANDO website for medical devices falling under the Medical Device Regulation (MDR, 2017/745) and 5 are now listed for the In Vitro Diagnostics Regulation (IVDR, 2017/746). These numbers are still well short of the number needed to cope with the anticipated influx of requests to Notified Bodies…
The US Food and Drug Administration (FDA) has announced that it will be carrying out a ‘soft launch’ of a real-time tracking system for pre-market submissions in January 2021. FDA committed to providing a submission tracker in its MDUFA commitments to the medical device industry, so during the January 2021 soft launch, the submission’s Official…
The European Commission’s Medical Device Coordination Group (MDCG) has published long-awaited guidance, MDCG 2020-16, that explains how to classify products for compliance with the EU’s In Vitro Diagnostics Regulation (IVDR, 2017/746). The IVDR is replacing the classification system from the In Vitro Diagnostics Directive (IVDD, 98/79/EC) with a risk-based system, which will require the reclassification…
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published on its website full details of how the device registration system for the UK will operate post-Brexit, from 1 January 2021. As already known, only UK entities will be allowed to make the device registrations, these being either UK device manufacturers, UK Responsible Persons…
Team-NB (the European association of notified bodies) has published a position paper on the IVD Regulation (2017/746) date of application, indicating that their member Notified Bodies would support maintaining the current May 2022 date of application, provided that the following conditions are met by the end of 2020: The tools necessary to perform conformity assessments…
The catalog collates a variety of regulatory science tools that the FDA’s Center for Devices and Radiological Health’s (CDRH) Office of Science and Engineering Labs (OSEL) developed and plans to expand as new tools become available. “These tools expand the scope of innovative science-based approaches to help improve the development and assessment of emerging medical…
