The General Safety and Performance Requirements (GSPRs) are detailed in the EU Medical Device Regulations (MDR) EU 2017/745 and detail what a manufacturer must show to prove that the medical devices they sell are safe and perform as intended.
Understanding EU MDR GSPRs Read More »
Electrical safety testing is essential for demonstrating the safety and performance of electrically powered medical devices. This guide explains IEC 60601-1, EMC testing, risk management, applicable standards and the evidence manufacturers need to support regulatory compliance in the UK, EU and other major markets.
Electrical Safety Testing and Validation for Medical Devices Read More »
Understand medical device sterilisation validation, including ISO requirements, sterilisation methods, SAL, bioburden, process validation and routine control.
Medical Device Sterilisation Validation: Methods, Standards & Requirements Read More »
Software as a Medical Device (SaMD) has fundamentally changed the clinical landscape. From AI-driven diagnostic image scanning to standalone smartphone apps used for real-time clinical decision-making, digital health tools are scaling faster than ever. However, understanding exactly how SaMD is regulated, classified, and maintained is critical to securing market access under current MHRA and EU Notified Body expectations.
Software as a Medical Device (SaMD): Regulatory & Development Guide Read More »
A practical guide to Post-Market Clinical Follow-up (PMCF) under the EU MDR, covering PMCF Plans, data collection methods, PMCF Evaluation Reports and how post-market clinical evidence feeds into Clinical Evaluation, risk management and ongoing medical device compliance.
Post-Market Clinical Follow-up (PMCF) Under the EU MDR Read More »
A comprehensive guide to post-market surveillance under the EU MDR, EU IVDR and UK MDR. Understand PMS plans, PMS reports, PSURs, vigilance, PMCF, PMPF and how manufacturers must monitor the safety and performance of medical devices and IVDs throughout their lifecycle.
Post-Market Surveillance (PMS) for Medical Devices and IVDs Read More »
Clinical Evaluation is a continuous process used to demonstrate that a medical device is safe, achieves its intended clinical performance and maintains an acceptable benefit-risk profile throughout its lifecycle. This complete guide explains every stage of clinical evaluation under the EU MDR, including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), clinical evidence, literature reviews, equivalence, PMCF, PMS and ongoing regulatory compliance.
Medical Device Clinical Evaluation: A Complete Guide Read More »
ISO 14971 provides the internationally recognised framework for identifying hazards, evaluating risks, implementing effective risk controls and monitoring safety throughout the lifecycle of a medical device or in vitro diagnostic device.
This comprehensive guide explains how manufacturers can apply ISO 14971:2019 in practice, maintain a compliant Risk Management File and demonstrate conformity with the EU MDR, EU IVDR and UK Medical Devices Regulations.
ISO 14971 Risk Management for Medical Devices and IVDs Read More »
Manufacturers based outside the European Union must appoint an EU Authorised Representative (EU AR or EC REP) before placing medical devices or in vitro diagnostic medical devices on the European market under the Medical Device Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR). Acting as the manufacturer’s legal representative within the EU, the Authorised Representative performs important regulatory duties, supports communication with Competent Authorities and shares legal responsibility for compliance. This guide explains who needs an EU Authorised Representative, their legal obligations under Article 11, and how to choose the right partner.
EU Authorised Representative Read More »
Biological Evaluation is a risk-based process used to demonstrate that a medical device is biologically safe for its intended clinical use. This complete guide explains how ISO 10993 supports Biological Evaluation, when biocompatibility testing is required, how Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs) are developed, and how Biological Evaluation integrates with Risk Management and Clinical Evaluation throughout the device lifecycle.
Biological Evaluation of Medical Devices: Complete ISO 10993 Guide Read More »
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