The number of Notified Bodies cleared to offer services in accordance with the Medical Device Regulation (MDR, 2017/745) continues to creep up, with two more companies being identified on the NANDO database since the beginning of the year, these being: SGS Fimko OY, Finland, and Istituto Superiore di Sanita (ISS), Italy The number of Notified…
Health Canada has recently updated its list of recognised standards to include 14 new standards, the replacement of 29 standards with newer editions, and the removal of three standards. Stakeholders have until 16 March 2021 to comment on the revised list. In addition, Health Canada is reminding companies that its rules on post market surveillance…
The European Commission has released the names of members appointed to its 12 expert panels on medical devices and in vitro diagnostics (IVDs). The expert panels, established under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), will provide scientific, technical and clinical input to the Commission, its Medical Device Coordination Group (MDCG),…
As a result of the Covid-19 pandemic, device manufacturers preparing for compliance with the Medical Device Regulation (MDR, 2017/745) have suffered delays with notified body audits, because of travel restrictions. The Commission has therefore decided to allow ‘virtual audits’ under certain conditions, and has published a ‘Commission Notice‘ in the Official Journal to set out…
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…
