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  • Are these findings observations in your CERs ?

    1 March 2021 CER

    Some companies finished their MED DEV R4 updates while some going through their NB reviews currently. Most of the IIb and III CERs that manufacturers compiled are good with REV 4 but may not be with EU MDR (especially in the areas of Equivalence, if claimed and other areas like SOA and PMCF parts which […]

  • Is your Diagnostic State-of-Art?

    1 March 2021 IVDR

    Are you sure from IVDR perspective ? You being “SURE”, or your company thinks their Devices have SOA does not help as it needs to be “Documented” to get an OK from Notified Bodies going forward. If you have Diagnostics in Europe and as they fall into EU IVDR, this new regulation mentions the term […]

  • Medical Devices – Regulatory Updates – February Volume 2

    18 February 2021 Regulatory Updates

    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 […]

  • Medical Devices – Regulatory Updates – January Volume 1

    6 January 2021 Regulatory Updates

    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 […]

  • Medical Devices – Regulatory Updates December Volume 1

    3 December 2020 Regulatory Updates

    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 […]

  • EU MDR Implementation Extension – helps in Compliance Planning

    26 November 2020 EU MDR

    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 […]

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