Learning Objectives

By the end of this module you will be able to:

1Navigate the key Articles and Annexes of MDR (EU 2017/745) and IVDR (EU 2017/746)

2Locate relevant MDCG guidance documents for specific regulatory questions

3Cross-reference regulatory provisions by topic (classification, PMS, vigilance, UDI, etc.)

4Use the library as a practical resource for day-to-day regulatory queries

Regulatory Reference Library

MDR/IVDR Articles, Annexes & MDCG Guidance — Searchable Cross-Reference

A comprehensive, searchable reference covering the key Articles, Annexes, and MDCG guidance documents of the MDR (EU) 2017/745 and IVDR (EU) 2017/746. Use the filters and search to quickly find the regulatory provisions relevant to your needs.

Filters:

33 Articles16 Annexes16 MDCG Documents

How to Use This Reference

Search by article number, topic keyword, or any text (e.g., "PSUR", "Class III", "cybersecurity")

Filter by regulation (MDR, IVDR, or Both) and by topic area to narrow your search

Cross-reference between Articles, Annexes, and MDCG guidance using the Related links in each entry

MDCG documents link to the official EC Health Portal for the full-text documents

Knowledge Check

4 questions · 80% required to pass

Q1.What is the purpose of MDCG guidance documents?

Q2.Which MDR Annex contains the General Safety and Performance Requirements?

Q3.What role does the HPRA play as Ireland's competent authority under MDR/IVDR?

Q4.What is a harmonised standard in the context of MDR?

0/4 answered

Print-Friendly Summary

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