The US Food and Drug Administration (FDA) has launched a new webpage aimed at providing support and advice to medical device manufacturers on the steps needed to demonstrate device biocompatibility in submissions to the Agency. The website introduces the subject by stating: “These resource pages are intended to explain terms and concepts important for the…
The European Commission’s Medical Device Coordination Group (MDCG) has issued a new guidance in the form of a Q&A document, introduced as being a “high-level document aimed at addressing the most pertinent questions relating to custom-made devices falling under Regulation (EU) 2017/745 on medical devices (MDR)”. The document is titled MDCG 2021-3 ‘Questions and Answers…
The US Food and Drug Administration (FDA) is building a secure, web-based tracker that displays the Center for Devices and Radiological Health’s progress on medical device submissions focused on premarket review. The progress tracker is the first feature of a larger platform to help FDA collaborate with the medical device industry. FDA is currently seeking…
The International Standardisation Organisation (ISO) has now published a new standard in the biocompatibility series ISO 10993 that specifies the use of laboratory-grown skin for irritation testing, as an option to animal testing. The new standard is ISO 10993-23:2021, titled ‘Biological evaluation of medical devices — Part 23: Tests for irritation’, which replaces the irritation…
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…
