MDR Knowledge Resource Groups
Post-Market Surveillance
How to build and run a compliant PMS system under EU MDR — PMS plan, PSUR, vigilance reporting, EUDAMED, and how post-market data feeds back into your technical documentation.
Total
11
Articles
10
Forms
1
Market Access & CE Marking
How to navigate the CE marking process under EU MDR — Notified Body selection, conformity assessment routes, Declaration of Conformity, Authorised Representative, UDI, and EUDAMED registration.
Total
11
Articles
10
Forms
1
Legacy Device Transition
How manufacturers with MDD or AIMDD-certified devices navigate the MDR transition — Article 120 provisions, extended deadlines, sell-off rules, and what needs to happen before the transition window closes.
Total
8
Articles
7
Forms
1
Labelling & IFU
What EU MDR requires on your device label and in your instructions for use — mandatory content, symbol rules, electronic IFU, language obligations, and how labelling connects to UDI and EUDAMED.
Total
4
Articles
3
Forms
1
Quality & Risk Management
How to build and maintain a compliant QMS and risk management process under EU MDR — ISO 13485, ISO 14971, conformity assessment routes, and how quality and risk evidence feeds into your technical documentation.
Total
11
Articles
10
Forms
1
MDR Basics
The foundational regulatory framework of EU MDR 2017/745 — device classification, product categories, key obligations, and how the regulation is structured.
Total
12
Articles
11
Forms
1
Clinical Evaluation
How to build and maintain clinical evidence under EU MDR — CER structure, equivalence, PMCF, and what auditors actually look for.
Total
12
Articles
11
Forms
1
Software as a Medical Device
How standalone software qualifies and is classified as a medical device under EU MDR — including cybersecurity, clinical evaluation, and AI/ML considerations.
Total
11
Articles
10
Forms
1
Technical Documentation
How to structure and maintain compliant technical documentation under EU MDR Annex II and III — from GSPR traceability to what Notified Bodies actually scrutinise.
Total
16
Articles
10
Forms
6
General Resources
Cross-category resources, platform tutorials, and general information about medical device compliance.
Total
13
Articles
13
Forms
0
MDR Knowledge Resource Groups
Navigating EU MDR 2017/745 means working across many interconnected areas of regulation — from understanding the legislation itself, to building technical documentation, to establishing a quality management system, to maintaining post-market obligations after CE marking. MDR Academy organises its knowledge into focused resource groups so you can find what is relevant to your current stage in the process.
The resource groups cover the full scope of the EU Medical Device Regulation, including:
- EU MDR 2017/745 legislation — scope, definitions, obligations for manufacturers, authorised representatives, importers, and distributors
- Device classification — classification rules under Annex VIII, borderline products, and determining the correct conformity assessment route
- Conformity assessment — routes to CE marking, when a Notified Body is required, and what the assessment process involves
- Technical documentation — building a compliant technical file under Annex II and III, General Safety and Performance Requirements (GSPR), and risk management
- Quality Management System (QMS) — ISO 13485 implementation, Article 10 obligations, and QMS requirements for MDR compliance
- Clinical evaluation — Clinical Evaluation Plans (CEP) and Reports (CER), PMCF, and clinical evidence standards required under MDR
- Post-market surveillance (PMS) — PMS plans, Periodic Safety Update Reports (PSUR), vigilance reporting, and ongoing obligations after CE marking
AI Participation & Regulatory Notice
The content on this page may be partially assisted by Artificial Intelligence (AI) to improve readability and ensure clarity.
While our team audits this content, please be aware:
- Accuracy: AI-assisted interpretations may contain nuances that differ from official MDCG guidance.
- Timeliness: Medical Device Regulations (MDR) are subject to updates. Always verify critical information against the official EUR-Lex database.
- Liability: MDR Academy provides these resources for educational purposes only. They do not constitute legal advice.