EU MDR and IVDR Guides

Master EU MDR/IVDR compliance with our step by step guide to medical device clinical evaluation. Learn how to create an audit-ready clinical evaluation report.

Learn EUDAMED registration steps for SRN, UDI data, Master UDI-DI, importer linking, swissdamed registration, data upload methods, and compliance planning.

Learn the EU packaging and packaging waste regulation, including PPWR compliance, packaging DoC, Annex VII technical files, supplier evidence, and audits.

Post-Market Surveillance (PMS) under EU IVDR 2017/746. Understand PMS plans, PMSR, PSUR, PMPF, and MDCG guidance for IVD compliance.

Ensure your device meets EU market requirements with a detailed guide on Declaration of Conformity (DoC) for MDR and IVDR. Learn the steps, required documents, and common mistakes to avoid a smooth CE marking process.

Understand EU language requirements under MDR & IVDR. Ensure label & IFU compliance for medical devices across Member States.

Compliant with EU IVDR 2017/746 by understanding the role of Post-Market Performance Follow-up (PMPF) for IVD devices.

General Safety and Performance Requirements under IVDR for IVD manufacturers. Understand compliance essentials from design to post-market processes

Learn how to prepare and submit Periodic Safety Update Reports (PSUR) under EU MDR 2017/745. Covers PSUR frequency, content, submission process, and compliance tips for medical device manufacturers.

A complete MDR 2017/745 guide for manufacturers of Annex XVI devices without medical purpose, covering classification to compliance.

The updated EU MDR timeline for 2024 to 2028. Understand deadlines, obligations, and how to maintain compliance.

Learn the PSUR requirements under IVDR 2017/746 for Class C & D IVDs, including submission rules, benefits, and reporting essentials.

Understand Basic UDI-DI and UDI registration process under EU MDR and IVDR regulations. Ensure compliance and streamline your EUDAMED device registration

How EU market surveillance under MDR/IVDR affects medical device and IVD manufacturers and how to stay compliant.

Learn how to apply for and obtain an Actor Registration for a Single Registration Number (SRN) in the EUDAMED system

Understand how Notified Bodies and manufacturers manage certificates and SSCPs in EUDAMED.

Learn how ISO 14971 and AFAP requirements help manufacturers identify, control, and monitor risks throughout the medical device lifecycle.

Learn how an EU MDR quality management system supports medical device regulatory compliance, Article 10 requirements, PMS, PRRC, and audits.

Understand PMS under EU MDR, its purpose, plan, reporting, and role in long-term device safety. A clear guide for manufacturers.

The CE mark indicates that a medical device complies with all the requirements of the EU MDR and is approved for sale within the EU market.

Unique Device Identification (UDI) system, including UDI-DI, UDI-PI, labeling, database registration, and implementation deadlines.

How to structure Technical Documentation and PMS files under EU MDR 2017/745 Annex II & III for medical device compliance.

Learn how to comply with EU MDR 2017/745 from classification to post-market requirements. Practical insights for manufacturers.

Learn about the Risk Management Report (RMR) under IVDR 2017/746, focusing on risk identification, evaluation, and mitigation for IVD device safety and performance.

Ensure EU IVDR compliance with a complete Performance Evaluation Report (PER), covering SVR, APR, CPR, PMPF, and risk-benefit analysis.

Learn how to create a compliant Performance Evaluation Plan (PEP) under IVDR 2017/746 for IVD devices, covering key requirements and best practices

Learn how to structure and maintain compliant technical documentation for in vitro diagnostic (IVD) devices under EU IVDR 2017/746

Learn how to draft a compliant Clinical Performance Report for your IVD device under IVDR 2017/746. regulatory expectations, and performance evaluation tips.

Analytical Performance Reports (APR) for EU IVDR compliance. Learn key parameters, study design, and documentation requirements for CE marking of IVDs.

Learn about the scientific validity requirements under EU IVDR 2017/746 for in vitro diagnostic devices (IVDs). Understand how manufacturers must demonstrate the analyte's association with clinical conditions, performance evaluation, and regulatory compliance.

Clinical evaluation under MDR including CEP, CER, PMCF, and benefit-risk analysis for CE marking success.

Learn how a Literature Review Report supports IVDR compliance through scientific validity, analytical performance & clinical performance evidence.

In Vitro Diagnostic Regulation are Ensure IVDR Compliance for Class A, B, C & D devices, device registration, meet 2026 deadlines, and secure EU market access.