EMA Regulatory

MDCG Guidance Documents: A Practical Navigation Guide for EU MDR Compliance

Arun Nagarathanam • Aruntastic
Published: 21 Jan 2026
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Updated: 21 Jan 2026

Quick Answer

MDCG guidance documents are non-binding interpretations of EU MDR/IVDR issued by the Medical Device Coordination Group. They're organized into six core categories: Clinical Evaluation, Notified Bodies, Post-Market Surveillance, Software/SaMD, UDI/EUDAMED, and Borderline Products. While not legally binding, these documents represent the expected standard for MDR compliance.

You're preparing for a Notified Body audit. The auditor asks about your clinical evaluation approach for a Class IIb implantable device. You cite your internal procedure—but they want to know which MDCG document you followed.

There are over 100 MDCG documents. Some have been revised multiple times. Some overlap. Some contradict earlier positions.

This guide maps the territory so you can find exactly what you need—and know when a document applies to your situation.

What Is the MDCG?

The Medical Device Coordination Group (MDCG) is established under Article 103 of the MDR. It brings together representatives from all EU Member States and is chaired by the European Commission.

The MDCG's primary role is to provide advice and assistance to the Commission and Member States on implementation of the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746.

MDCG Subgroups

The MDCG operates through specialized subgroups that focus on specific topics:

  • • Borderline and Classification — Product qualification questions
  • • Clinical Investigation and Evaluation — CER and clinical study requirements
  • • Market Surveillance — PMS and vigilance
  • • Notified Bodies — NB designation and oversight
  • • Standards — Harmonised standards application
  • • UDI and EUDAMED — Database and identification requirements

The Six Core Guidance Categories

Why This Matters: Understanding the category structure helps you find relevant documents faster. Instead of scrolling through a long list, you can go directly to the section that addresses your compliance question.

Infographic showing six MDCG guidance categories in a hub-and-spoke diagram: Clinical Evaluation, Notified Bodies, Post-Market Surveillance, Software SaMD, UDI EUDAMED, and Borderline Products
MDCG Guidance Document Categories for EU MDR/IVDR Compliance

Question

Which MDCG Category Do You Need?

Evidence for device safety and performance

Clinical Evaluation → MDCG 2020-5, 2020-6, 2020-13

Conformity assessment or NB relationship

Notified Bodies → MDCG 2019-6, 2022-11, 2022-14

Post-market activities or vigilance

Post-Market Surveillance → MDCG 2020-7, 2025-10

Standalone software or SaMD questions

Software/SaMD → MDCG 2019-11, 2020-1

UDI labeling or EUDAMED registration

UDI/EUDAMED → MDCG 2018-1, 2019-4, 2025-7

Is my product a medical device?

Borderline → MDCG 2022-5, Manual on Borderline

Clinical Evaluation Guidance

Clinical evaluation guidance covers how manufacturers should compile and assess clinical evidence to demonstrate conformity with General Safety and Performance Requirements.

Document Topic Key Content
MDCG 2020-5 Clinical Evaluation – Equivalence Criteria for claiming equivalence, contract requirements with equivalent device manufacturer
MDCG 2020-6 Clinical Evaluation – Sufficient Clinical Evidence What constitutes sufficient evidence, role of post-market data
MDCG 2020-13 Clinical Evaluation – Post-Market Clinical Follow-up PMCF plan and report requirements, methods for gathering post-market clinical data
MDCG 2021-24 Clinical Evaluation Report Template Standardized CER structure and content requirements
MDCG 2023-7 Clinical Investigation Q&A Answers to common questions on clinical investigation conduct

Key Change from MDD

Under the MDR, claiming equivalence to a competitor's device requires a contract with the competitor giving access to their technical documentation. This is a significant departure from MDD practice and is detailed in MDCG 2020-5.

Notified Body Guidance

These documents address Notified Body designation, surveillance, and the conformity assessment process.

Document Topic Key Content
MDCG 2019-6 Questions & Answers for Notified Bodies Clarifications on NB requirements under MDR Annex VII
MDCG 2022-11 Rev.1 Notified Body Capacity Recommendations on NB capacity constraints, transparency on timelines
MDCG 2022-14 Transition and NB Availability Addressing device availability during MDR/IVDR transition
MDCG 2022-13 Rev.1 Joint Assessments of Notified Bodies Process for NB re-assessments every four years
MDCG 2024-12 CAPA Plans for NB Assessments Template for corrective and preventive action plans following NB assessment

Post-Market Surveillance Guidance

PMS guidance covers the manufacturer's obligations to proactively collect and analyze post-market data, as well as vigilance reporting requirements.

MDCG 2020-7

PMS Plan and Report Templates

Provides standardized templates for PMS plans and Periodic Safety Update Reports (PSURs).

MDCG 2025-10

Updated PMS Guidance (December 2025)

Latest guidance on post-market surveillance for medical devices and IVDs. Supersedes earlier versions.

PMS Documentation Requirements

  • Post-Market Surveillance Plan per Article 84
  • Post-Market Surveillance Report for Class I devices
  • Periodic Safety Update Report (PSUR) for Class IIa, IIb, III
  • Post-Market Clinical Follow-up (PMCF) Plan and Report
  • Trend reporting procedures for incidents

Software and SaMD Guidance

Software guidance addresses qualification (is it a medical device?) and classification of standalone medical device software.

Document Topic Key Content
MDCG 2019-11 Software Qualification and Classification Flowcharts for determining if software is a medical device, classification rules
MDCG 2020-1 Clinical Evaluation of Software How to apply clinical evaluation requirements to SaMD, including AI/ML considerations

Software Classification Under MDR Rule 11

MDR Rule 11 significantly changed software classification. Software intended to provide information for diagnostic or therapeutic decisions is now at minimum Class IIa. MDCG 2019-11 provides decision flowcharts to help manufacturers navigate these rules.

UDI and EUDAMED Guidance

These documents cover Unique Device Identification requirements and registration in the European database on medical devices.

Document Topic Key Content
MDCG 2018-1 UDI Assignment to Medical Devices How to assign and use UDI-DI and UDI-PI
MDCG 2019-4 Timelines for UDI Registration Phased timelines for UDI-DI registration in EUDAMED
MDCG 2025-7 Rev.1 Master UDI-DI Implementation Updated timelines for contact lenses and spectacle frames (December 2025)

Borderline Products Guidance

Why This Matters: Borderline guidance helps you determine whether your product is regulated as a medical device at all—or whether it falls under cosmetics, biocides, or pharmaceutical legislation.

MDCG 2022-5

Borderline: Medical Devices vs Medicinal Products

Criteria for distinguishing devices from medicines, including products with ancillary medicinal substances.

Manual on Borderline and Classification

EC Practical Guidance

Extensive manual with product-specific examples covering borderline between devices, cosmetics, biocides, and medicines.

How to Use MDCG Documents in Practice

Step 1: Identify Your Compliance Question

Start with the specific regulatory requirement you need to address. Are you writing a clinical evaluation report? Preparing for a Notified Body audit? Classifying a new software product?

Step 2: Find the Relevant Category

Use the category map above to identify which MDCG subgroup addresses your topic. Check for the most recent version (look for "Rev." suffix).

Step 3: Cross-Reference with MDR Articles

MDCG documents interpret specific MDR articles. Always read the guidance alongside the relevant regulation text to understand both the legal requirement and its practical implementation.

Step 4: Document Your Approach

Reference the MDCG document in your technical documentation. This demonstrates to Notified Bodies and competent authorities that you've followed the agreed interpretation.

Staying Current with MDCG Updates

MDCG documents are published and updated regularly. The official source is the European Commission health portal.

Official MDCG Guidance Source

All MDCG-endorsed documents are published at:

health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en

Bookmark this page and check it regularly for updates, especially before major submissions or audits.

References

  1. 1. Regulation (EU) 2017/745 on medical devices (MDR), Article 103 - Medical Device Coordination Group
  2. 2. MDCG 2020-5: Clinical Evaluation – Equivalence
  3. 3. MDCG 2020-6: Clinical Evaluation – Sufficient Clinical Evidence
  4. 4. MDCG 2019-11: Guidance on Qualification and Classification of Software
  5. 5. MDCG 2025-10: Guidance on Post-Market Surveillance (December 2025)
  6. 6. European Commission MDCG Guidance Portal

Need faster answers? RegulatorySense delivers instant guidance on MDCG requirements.

FAQ

Are MDCG guidance documents legally binding?
No, MDCG guidance documents are not legally binding. They represent the agreed interpretation of the regulations by Member State competent authorities and the European Commission. However, they carry significant weight in practice, as Notified Bodies and competent authorities typically expect manufacturers to follow them.
How often are MDCG documents updated?
MDCG documents are updated as needed when issues arise or regulations change. Some documents go through multiple revisions (indicated by 'Rev.1', 'Rev.2', etc.). The EC publishes new documents regularly—December 2025 alone saw updates to PMS guidance (MDCG 2025-10) and UDI guidance (MDCG 2025-7 Rev.1).
Where can I find all MDCG guidance documents?
All MDCG-endorsed guidance documents are published on the European Commission's official health portal at health.ec.europa.eu under Medical Devices > New Regulations > Guidance. Documents are organized by topic and include both MDR and IVDR guidance.
What's the difference between MDCG and CAMD documents?
CAMD (Competent Authorities for Medical Devices) documents typically predate MDR/IVDR full application or address transition-specific issues. MDCG documents are the current standard for MDR/IVDR implementation guidance. Some CAMD documents (like the MDR Transitional Provisions FAQ) remain relevant alongside MDCG guidance.

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