Legal Knowledgebase

The EU MDR regulatory landscape is built on a wide body of official documents — the regulation itself, implementing acts, delegated acts, MDCG guidance, harmonised standards, and decisions from Competent Authorities. Finding, tracking, and making sense of these sources is one of the practical challenges every manufacturer faces.

This knowledgebase is MDR Academy's curated collection of important official sources, references, and regulatory documents relevant to EU MDR 2017/745. Rather than reproducing the content of these documents, we organise and contextualise them — so you can understand what each source is, when it applies, and where to find the authoritative version.

What this knowledgebase covers

As the collection grows, it will include references and orientation across:

• The regulation itself — Regulation (EU) 2017/745 and its corrigenda, including consolidated versions
• Implementing and delegated acts — Commission decisions and regulations adopted under MDR authority
• MDCG guidance documents — the full library of Medical Device Coordination Group guidance, covering classification, clinical evaluation, borderline products, UDI, EUDAMED, and more
• Harmonised standards — key standards referenced under MDR, including ISO 13485, ISO 14971, IEC 62304, and their relationship to the GSPR
• EUDAMED — guidance on the European database on medical devices, registration requirements, and timelines
• Notified Body resources — publicly available orientation documents from Notified Bodies on their assessment processes
• Competent Authority guidance — national guidance from EU member state authorities relevant to MDR implementation

A note on this page

This knowledgebase is actively being built. Sources and references are added as we identify and verify them. All entries link to official or authoritative sources — we do not host regulatory documents ourselves. If you believe an important source is missing, you are welcome to contact us at mrdacademy.eu@gmail.com.