The Medical Devices Coordination Group (MDCG) has published a 31-page document, MDCG 2021-1, titled ‘Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional’. Interestingly, the first page states: “The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission.”…
The European Commission has published a new guidance document titled ‘Management of Legacy Devices, MDR EUDAMED‘, explaining “how Legacy Devices will be identified in EUDAMED and the way the different Unique Device Identifiers for the Legacy Devices will be generated/assigned”. The document clarifies that “Legacy Devices are defined as Medical Devices, Active Implantable Medical Devices…
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…
