EU Regulations

Illustration showing the medical device clinical evaluation process under the EU MDR, with scientific literature, clinical investigations, Post-Market Surveillance, Post-Market Clinical Follow-up, risk management and Clinical Evaluation Reports combining to demonstrate device safety, clinical performance and an acceptable benefit-risk profile for CE marking.

Medical Device Clinical Evaluation: A Complete Guide

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, UK Regulations /

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 »

Professional hero banner illustrating the ISO 14971 risk management process for medical devices and in vitro diagnostic medical devices, showing the eight stages of risk management including planning, hazard identification, risk analysis, risk evaluation, risk control, residual risk evaluation, risk management reporting and post-production monitoring to support compliance with the EU MDR, EU IVDR and UK Medical Devices Regulations.

ISO 14971 Risk Management for Medical Devices and IVDs

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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.

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Illustration showing the role of an EU Authorised Representative under the EU MDR and IVDR, depicting a non-EU manufacturer, the Authorised Representative, Article 11 compliance documentation, EUDAMED registration, Competent Authority communication and medical device regulatory oversight within the European Union.

EU Authorised Representative

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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.

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Illustration showing the biological evaluation of a medical device under ISO 10993, highlighting the risk-based process from the Biological Evaluation Plan (BEP) through biological assessment, Biological Evaluation Report (BER), Post-Market Surveillance (PMS), and integration with ISO 14971 Risk Management throughout the medical device lifecycle.

Biological Evaluation of Medical Devices: Complete ISO 10993 Guide

Blog, EU Regulations, Guides and Advice, Medical Device Validation, Standards, UK Regulations, USA Regulations /

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 »

Professional illustration of the CE marking process for medical devices and in vitro diagnostic medical devices, showing technical documentation, risk management, clinical evaluation, quality management, an EU Declaration of Conformity and a CE marked medical device under the EU MDR 2017/745 and IVDR 2017/746.

CE Marking Medical Devices: A Complete Guide to EU MDR & IVDR Compliance

Blog, EU Regulations, Guides and Advice, Standards, UK Regulations /

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 »

Hero image illustrating the process of determining whether a product is a medical device, featuring examples of medical and non-medical products alongside CE Marking and UKCA symbols, highlighting intended purpose, mode of action, medical claims, borderline products and the regulatory pathway under the EU MDR and UK Medical Devices Regulations.

Is My Product a Medical Device? How to Determine Whether the EU MDR or UK Regulations Apply

Blog, Client Questions, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, UK Regulations, USA Regulations /

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.

Is My Product a Medical Device? How to Determine Whether the EU MDR or UK Regulations Apply Read More »

Skin Irritation Testing in the biological evaluation of medical devices (ISO 10993-23)

ISO 10993-23 Skin Irritation Testing Explained: Methods, Requirements and Regulatory Expectations

Blog, EU Regulations, Guides and Advice, Medical Device Pre-launch, Medical Device Validation, Standards, UK Regulations, USA Regulations /

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.

ISO 10993-23 Skin Irritation Testing Explained: Methods, Requirements and Regulatory Expectations Read More »

Cytotoxicity Testing in Medial Devices ISO 10993-5

Cytotoxicity Testing in Medical Device Biological Evaluation

Blog, EU Regulations, Guides and Advice, Medical Device Pre-launch, Medical Device Validation, Standards, UK Regulations, USA Regulations /

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.

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drug Infusion bag

Drug Stability in Medical Devices: Syringes, Infusion Sets and Bags

Blog, EU Regulations, Guides and Advice, Medical Device Pre-launch, Medical Device Validation, USA Regulations /

Ensuring the stability of drugs in contact with medical devices such as syringes, infusion administration sets and infusion administration bags is paramount. This article delves into the importance of drug stability testing, the challenges faced, and the methodologies employed to guarantee that the drugs administered through these devices remain safe and effective.

Drug Stability in Medical Devices: Syringes, Infusion Sets and Bags Read More »

E&L Testing in medical devices

ISO 10993 Extractables and Leachables Testing: Chemical Characterisation and Toxicological Risk Assessment

Blog, EU Regulations, Medical Device Pre-launch, Medical Device Validation, Standards, USA Regulations /

In medical device design and development and manufacturing, ensuring the safety and biocompatibility of products is paramount. As part of the biological evaluation process, extractables and leachables (E&L) testing plays a crucial role. This testing ensures that any chemicals that might migrate from the device materials into the body do not pose a risk to patients. The ISO 10993 standard series provides comprehensive guidelines for the biological evaluation of medical devices, including protocols for E&L testing. In this blog, we will delve into the importance of extractables and leachables testing, its procedures, and its relevance within the ISO 10993 framework.

ISO 10993 Extractables and Leachables Testing: Chemical Characterisation and Toxicological Risk Assessment Read More »

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