All Medical device articles
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Industry newsGreater post-market surveillance for medical devices
New draft legislation was laid before the UK Parliament on 21 October 2024 which would require greater post-market surveillance (PMS) for medical devices on the market in Great Britain.
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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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Industry newsSponge-on-a-string cuts wait time for Barrett’s diagnosis
A procedure to test for a precancerous condition of the oesophagus, which uses a novel medical device, is under trial in NHS England.
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JournalChemical characterisation: a critical first step for medical device development
Regulatory Rapporteur February 2024 | Volume 21 | No.2 Introduction Chemical characterisation is an important tool to demonstrate biological safety of medical devices prototype before pre-clinical and clinical assessment. This article proposes a proactive approach to integrate chemical characterisation ...
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JournalOverview of medical device regulations in Canada
Regulatory Rapporteur February 2024 | Volume 21 | No.2 Abstract Despite being a relatively small jurisdiction, Canada’s Medical Device Directorate (MDD) plays a dynamic role in shaping global regulations and taking a leadership role in regulatory harmonisation and convergence. ...
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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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Industry newsDevices sold on second-hand market retain sensitive data
Infusion pumps sold on secondary markets in the US were found to carry sensitive information about the hospitals that once owned them.
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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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Industry newsAI-enabled imaging cuts serious stroke diagnosis times
Med-Tech Innovation Conference keynote ‘fireside chat’: Dr Paul Bhogal, Royal London Hospital and Gianluca Casali, Johnson & Johnson.
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Industry newsIndia backs ambitious expansion in spending to support medical devices
India’s seeks to cut its dependence on imports of medical devices.
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JournalMedical device standards update: September 2022
This edition of our regular column updates the progress of applicable standards to September 2022
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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 ...