All Post-market surveillance (PMS) articles
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JournalArtificial intelligence and post-market surveillance
Artificial intelligence (AI) is a force that is both feared and revered for promising revolutionary improvements in many fields. While tools like ChatGPT may create an impression of AI being easy to use, such wide AI applications are prone to hallucinations, or misleading information, and therefore can be dangerous in the context of post-market surveillance (PMS). The more accurate narrow AI tools for PMS do not yet exist, but hold a lot of promise for the future. The solution for effective PMS by AI will require restructuring data into appropriate formats for machine learning (ML).
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JournalThe EU Medical Device Regulation: Balancing innovation with regulation
The EU Medical Device Regulation (EU MDR) 2017/745 was introduced in response to the need for tighter regulation of medical devices (MDs) in Europe. However, with the increased regulatory burden, there could be potentially hundreds of unanticipated ramifications, particularly for smaller manufacturers and start-ups. By increasing regulation so significantly in a relatively short time period, the very rules which are designed to protect patients may prevent them from accessing the treatment they need and stifle innovation, as start-ups inevitably struggle under the weight of new requirements. This article assesses the delicate balance between innovation and regulation and analyses the relationship between the two.
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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 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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JournalImpact of clinical data requirements following EU MDR (2017/745) & Clinical Evaluation Guidance (MEDDEV 2.7/1 Rev 4)
The EU Medical Device Regulation 2017/745 (EU MDR) and guidance on clinical evaluation (MEDDEV 2.7.1 Rev 4) have replaced the previous regulations governing the placing of medical devices on the European market. Concerning that these new requirements may be difficult to implement and pose an additional burden to Medical ...