All Medical device articles
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Industry newsEMA establishes new standard procedure for high-risk medical devices
The European Medicines Agency (EMA) has established a standard procedure for manufacturers of high-risk Class III and Class IIb medical devices to request scientific advice.
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JournalImplications of the EU’s AI Act for medical devices and in vitro diagnostic medical devices
The integration of artificial intelligence within healthcare has heralded a new era of innovation for medical devices and in vitro diagnostics. This article explores some implications of the EU’s AI Act for the existing regulatory frameworks governing MDs, specifically the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746.
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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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Industry newsEC announces evaluation of medical device and IVD regulations
The European Commission (EC) has announced an evaluation of Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
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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