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