All IVD articles
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Industry newsMHRA issues guidance on post-market surveillance regulation in Great Britain
The Medicines and Healthcare products Regulatory Agency (MHRA) has published The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation
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JournalMedical device standards update: March 2024
This edition of our regular column updates the progress of applicable standards to March 2024
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JournalMedical device standards update: November 2023
This edition of our regular column updates the progress of applicable standards to October 2023.
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JournalMedical device standards update: June 2023
This edition of our regular column updates the progress of applicable standards to March 2023.
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JournalEU expert panels for high-risk devices - another level of review?
The new EU regulations for medical device and in vitro diagnostic devices called for additional expert reviews for novel and high-risk devices. These newly formed committees have published three opinions for medical devices and fifteen opinions for IVDs. The opinions offer a detailed and critical review of data from both ...
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JournalThe new UK MDR - a great start to a long road ahead
On 29 March 2017, the UK invoked Article 50 of the Treaty on European Union (EU)[1] and began the withdrawal process from the EU. Despite the UK’s departure from the EU on 31 January 2020, EU legislation continues to apply in UK domestic law. This means that, for the medical ...
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JournalMedical device standards update: February 2022
This edition of our regular column updates the progress of applicable horizontal standards to February 2022
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Meeting ReportIVD5: How do I Implement IVDR? Some key practicalities
This session looked at the practicalities of IVDR implementation and considered how to prepare application documents, the expectations for performance evaluation (PE) and postmarketing clinical follow-up (PMCF).