Europe | Thailand (FDA) EUROPE 1. Guidance on applying human factors to medical devices MHRA has published guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks. This guidance reflects mainly the changes to the regulation of medical devices in the […]

Europe | US FDA | CANADA (HC) | Australia (TGA) | China (CMDE) | India (CDSCO) EUROPE 1. MHRA: Register medical devices to place on the market The following devices in Great Britain (England, Wales and Scotland) need to be registered with the MHRA under existing arrangements: Class I medical devices IVDs custom-made devices All […]

Europe | Australia (TGA) | Philippines (FDA) | China (CMDE) EUROPE 1. Converting Centrally Authorised Products (CAPs) to UK Marketing Authorizations (MAs) from 1 January 2021, ‘grandfathering’ and managing lifecycle changes This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products. This guidance will apply from 1 January 2021 in line with the […]

As the extended transition deadline 26 May 2021 is approaching, we should be ready for ensuring compliance with EU MDR. We have built a comprehensive plan that outlines the procedures, checklists, specific details and processes that you must follow to better understand and comply with these new EU MDR requirements. Immense efforts would be required […]

Europe | US FDA | Australia (TGA) | Malaysia (MDA) | Japan (PMDA) EUROPE 1.MDCG releases long-awaited IVD classification guidance The European Commission’s Medical Device Coordination Group (MDCG) released its much-anticipated guidance on the classification of in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR). The nearly 50-page guidance is intended to explain […]

While Post Market Surveillance (PMS) is mentioned in Annex X of the existing Medical Device Directive (MDD), it was not defined clearly in the MDD. Lack of clarity is completely removed with the publication of the new EU MDR. Not only is PMS defined in Article 2 (60), it is listed as one of the […]