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 »
Learn when a UK Responsible Person (UKRP) is required for medical devices placed on the Great Britain market, including UKRP responsibilities, MHRA registration, technical documentation, labelling and post-market compliance.
UK Responsible Person (UKRP): Complete Guide for Medical Device Manufacturers 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 »
CE marking demonstrates that a medical device or in vitro diagnostic medical device complies with the applicable requirements of the EU Medical Device Regulation (EU MDR 2017/745) or In Vitro Diagnostic Medical Device Regulation (IVDR 2017/746). This guide explains the CE marking process, device classification, conformity assessment, technical documentation, clinical and performance evaluation, Notified Body involvement, post-market surveillance and the steps manufacturers must complete before placing a device on the European market.
CE Marking Medical Devices: A Complete Guide to EU MDR & IVDR Compliance Read More »
Determining whether your product is a medical device is the first and most important step towards regulatory compliance. This guide explains how regulators assess intended purpose, mode of action and medical claims, helping you understand whether your product falls within the scope of the EU Medical Device Regulation (MDR), the UK Medical Devices Regulations or the IVDR. Whether you’re developing software, wearable technology, wellness products, cosmetics or innovative healthcare solutions, this article will help you identify the correct regulatory pathway and avoid common classification mistakes.
Skin irritation occurs when a substance causes inflammation or damage to the skin upon contact. For medical devices, this can be a serious concern, as they are often in prolonged contact with the skin. The consequences of not adequately testing for irritation can range from minor redness to severe dermatitis, leading to discomfort, injury, or even infection in users. Therefore, reliable testing methods are crucial to ensure that products are safe before they reach the market.
In the highly regulated world of medical devices, ensuring patient safety is paramount. One of the essential components of this safety assurance is cytotoxicity testing, specifically adhering to ISO 10993-5 standards. This blog explores the importance of ISO 10993-5 cytotoxicity testing, particularly for medical devices that come into direct contact with patients, and how it contributes to the overall safety and efficacy of these devices.
Cytotoxicity Testing in Medical Device Biological Evaluation Read More »
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