You've just discovered MDR. You don't know where to start. We've been there.

EU MDR 2017/745 is one of the most demanding regulatory frameworks a medical device manufacturer can face. The legislation is dense, the guidance is scattered, and the stakes — patient safety, market access, years of work — are high. When we went through it ourselves, we wished someone had laid it out clearly.

That is why we built MDR Academy.

What you will find here

MDR Academy is a structured knowledge platform covering the full scope of the EU Medical Device Regulation. Whether you are just beginning to understand what MDR requires or working through a specific part of your technical documentation, you will find practical, experience-based content across all major areas of the regulation:

• Regulatory framework — Understanding Regulation (EU) 2017/745, its scope, timelines, and transitional provisions
• Classification and conformity assessment — Device classification rules, conformity assessment routes, and when a Notified Body is required
• Technical documentation — Building your technical file under Annex II and III, including General Safety and Performance Requirements (GSPR)
• Clinical evaluation — Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), PMCF, and the role of clinical evidence under MDR
• Quality Management System — ISO 13485 implementation, Article 10 obligations, and QMS requirements for MDR compliance
• MDCG guidance documents — Plain-language orientation to official Medical Device Coordination Group guidance
• Post-market surveillance — PMS plans, PSUR, vigilance reporting, and ongoing obligations after CE marking

Who this is for

MDR Academy is for regulatory affairs professionals, quality managers, and founders of medical device startups who are navigating the MDR process — whether for the first time or looking to fill specific gaps in their understanding. The content is practical and experience-based, not a restatement of the legislative text.

What this is not

MDR Academy is a knowledge resource, not a regulatory consultancy. The content here does not constitute regulatory or legal advice, does not replace a qualified Regulatory Affairs professional, and does not guarantee any outcome with a Notified Body or Competent Authority. Use it to build your understanding and ask better questions — then work with the right professionals for the decisions that matter.