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 benefit-risk analysis
• Quality Management System (QMS) — ISO 13485 implementation, Article 10 requirements, and QMS obligations under MDR
• Clinical evaluation — Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF), and the standards of clinical evidence required under MDR
• Post-market surveillance (PMS) — PMS plans, Periodic Safety Update Reports (PSUR), vigilance reporting, and ongoing obligations after placing a device on the market
• MDCG guidance documents — orientation to official Medical Device Coordination Group guidance, including borderline, classification, clinical evaluation, and UDI guidance
• Unique Device Identification (UDI) — UDI requirements, EUDAMED registration, and device labelling obligations
• Labelling and instructions for use — MDR requirements for device labelling, symbols, and instructions for use (IFU)
• Authorised Representative and Responsible Person — roles, obligations, and requirements for non-EU manufacturers placing devices on the EU market

How to Use This Page

Select a category from the list below to browse all resources in that group. Some resources are available to all visitors; others require a Full Access account. If you are unsure where to start, the AI assistant available to Full Access users can help you identify which categories are most relevant to your situation.