In April 2019, the US Food and Drug Administration (FDA) published a discussion paper and request for feedback regarding their proposed regulatory framework for Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD). Following feedback from the industry, the FDA has now published a five part action plan. Read more “FDA details regulatory framework for AI/ML-Based Software as a Medical Device”
Category: Medical device
Keep up to date with the latest medical device news in the pharmaceutical industry.
European Commission temporarily allows notified bodies to perform remote audits
In light of the severe disruption caused by the COVID-19 pandemic, the European Commission (EC) has taken the decision to allow notified bodies to perform remote audits of medical device and in-vitro diagnostic medical device manufacturers. Read more “European Commission temporarily allows notified bodies to perform remote audits”
Canada implements new regulations to strengthen post-market surveillance and risk management of medical devices
Heath Canada is making changes to its Medical Devices Regulations with the aim of improving their ability to identify, assess and manage new risks for medical devices used in Canada. Read more “Canada implements new regulations to strengthen post-market surveillance and risk management of medical devices”
How to register with the MHRA to sell medical devices after Brexit
The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance for manufacturers who intend to register to sell medical devices in the Great Britain (GB) and Northern Ireland (NI) markets after 01 January 2021. Read more “How to register with the MHRA to sell medical devices after Brexit”
Classification of in-vitro diagnostics under IVDR
The European Commission’s (EC) Medical Device Coordination Group (MDCG) has released guidance on the classification of in-vitro diagnostic (IVD) medical devices under the incoming EU In-vitro Diagnostic Regulation (IVDR). Read more “Classification of in-vitro diagnostics under IVDR”
New CE certification paves the way for 3D personalised medical devices
One of the major obstacles slowing down the large scale adoption of 3D printing – especially in the medical industry – is CE certification. Read more “New CE certification paves the way for 3D personalised medical devices”
What is the new UKNI marking for medical devices?
Find out more about the new UKNI marking for medical devices being placed on the Northern Ireland (NI) market. Read more “What is the new UKNI marking for medical devices?”
Catch the latest updates to the MHRA transition period guidances
The Medicines and Healthcare products Regulatory Agency (MHRA) has published further guidance and updates in relation to supplying medicines and medical devices after the end of the transition period. Read more “Catch the latest updates to the MHRA transition period guidances”
Implications for Medical Device Usability Engineering following amendments to IEC 62366
International Standard IEC 62366-1: Application of usability engineering to medical devices, was updated and published in June 2020. Read more “Implications for Medical Device Usability Engineering following amendments to IEC 62366”
New version of the FDA guidance on the use of ISO 10993-1
The US Food and Drug Administration (FDA) has published an updated version of the guidance on the use of ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) to support medical devices application. Read more “New version of the FDA guidance on the use of ISO 10993-1”