EU Regulations

EU Authorised Representative Services for Medical Device & IVD Manufacturers

Leave a Comment / Authorised Representative, Blog, CE Marking, Client Questions, EU Regulations, EUDAMED, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, UK Regulations /

Selling medical devices or IVDs in Europe? If your company is based outside the EU, appointing an EU Authorised Representative (EC Rep) is a legal requirement under EU MDR 2017/745 and IVDR 2017/746. Patient Guard provides expert EU Authorised Representative services, EUDAMED support, regulatory guidance, and ongoing compliance management to help manufacturers access and maintain the European market with confidence.

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Predetermined Change Control Plans (PCCPs): The Future of Agile Compliance for Medical Device Software

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Learn how PCCPs help medical device software manufacturers manage updates, support AI systems, and enable agile compliance under evolving MDR and UKCA frameworks.

Predetermined Change Control Plans (PCCPs): The Future of Agile Compliance for Medical Device Software Read More »

The AI Act Omnibus Explained: What the 2026 EU Rules Mean for Medical Device and IVD Manufacturers

The AI Act Omnibus Explained: What the 2026 EU Rules Mean for Medical Device and IVD Manufacturers

Authorised Representative, Blog, Client Questions, EU Regulations, EUDAMED, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, UK Regulations /

Discover how the EU AI Act Omnibus affects AI medical devices and IVD manufacturers. Learn about the No Duplication principle, transparency rules, key 2026 and 2028 deadlines, and how MDR and IVDR compliance are converging with AI regulation.

The AI Act Omnibus Explained: What the 2026 EU Rules Mean for Medical Device and IVD Manufacturers Read More »

Post-Deadline Reality Check: I’ve Submitted My IVDR Class C – Now What?

Post-Deadline Reality Check: I’ve Submitted My IVDR Class C – Now What?

Authorised Representative, Blog, Client Questions, EU Regulations, EUDAMED, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, UK Regulations /

Submitted your IVDR Class C application? Learn what happens next, common causes of delays, review timelines, and why the September 2026 contract deadline is critical for maintaining EU market access.

Post-Deadline Reality Check: I’ve Submitted My IVDR Class C – Now What? Read More »

The MHRA 2026 Regulatory Roadmap Explained

The MHRA 2026 Regulatory Roadmap Explained

Authorised Representative, Blog, Client Questions, EU Regulations, EUDAMED, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, UK Regulations /

Learn how the MHRA 2026 Regulations will impact UKCA compliance, IVD classifications, AI medical devices, IRP pathways, and post-market surveillance.

The MHRA 2026 Regulatory Roadmap Explained Read More »

medical device regulatory consultancy

Medical Device Regulatory Consulting Services Explained

Authorised Representative, Blog, Client Questions, EU Regulations, EUDAMED, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, UK Regulations /

Explore medical device regulatory consulting services for ISO, FDA, EU, and more. Build compliant systems, pass audits, and scale globally with expert support.

Medical Device Regulatory Consulting Services Explained Read More »

ISO-14971-Risk-Management-Implementation-Guide

ISO 14971 Risk Management Implementation Guide

Authorised Representative, Blog, Client Questions, EU Regulations, EUDAMED, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, UK Regulations /

Medical devices exist to improve health outcomes, but every device carries potential risk. Managing those risks in a structured, documented, and defensible way is essential for regulatory approval and patient safety.

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Medical-Device-Labelling-Requirements-Explained-

Medical Device Labelling Requirements Explained

Authorised Representative, Blog, Client Questions, EU Regulations, EUDAMED, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, UK Regulations /

Medical device labelling is more than a packaging exercise. It is a regulatory requirement that communicates essential information about a device’s identity, safety, and intended use.

Medical Device Labelling Requirements Explained Read More »

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