MDCG Guidance Documents: Practical Guidance for MDR and IVDR Compliance
The Medical Device Coordination Group (MDCG) publishes the guidance documents that shape how manufacturers, Notified Bodies, and competent authorities apply the EU MDR and IVDR. While not legally binding, they set the practical standard for conformity assessments, clinical evaluations, safety reporting, and device classification. We provide manufacturer-focused breakdowns of the most relevant MDCG documents, connected to the regulatory and clinical services where we apply them.
What Is the MDCG and Why Do Its Guidances Matter?
The Medical Device Coordination Group is established under Article 103 of the MDR (Regulation (EU) 2017/745) and Article 99 of the IVDR (Regulation (EU) 2017/746). It is composed of representatives from all EU Member States and chaired by the European Commission.
The MDCG issues guidance documents that provide a common understanding of how the MDR and IVDR should be applied in practice. These documents are identified by a standardised format, “MDCG Year-Number” and are regularly reviewed, revised, and occasionally archived.
3 reasons why MDCG guidances are essential for manufacturers
- Notified Bodies use them. NBs reference MDCG documents directly during conformity assessments. Aligning your documentation to these guidances reduces review cycles and NB questions.
- Competent Authorities rely on them. Member States use MDCG positions to interpret regulatory requirements, particularly for clinical investigations and market surveillance.
- They evolve. MDCG guidances are living documents. A classification rule interpretation can change between revisions. Staying current is not optional.
We monitor all MDCG publications and integrate the latest positions into our clinical, regulatory, and quality management workflows across MDR and IVDR programmes.
Key MDCG Guidance Documents for Manufacturers
A curated selection of the MDCG documents most relevant to medical device and IVD manufacturers. Each entry links to our detailed expert analysis.
| MDCG Document | Topic | Regulation | Current Revision | MDx CRO Analysis |
|---|---|---|---|---|
| MDCG 2020-13 | Clinical Evaluation Assessment Report (CEAR) Template | MDR | Rev. 0 July 2020 | Read our guide → |
| MDCG 2020-16 | Classification Rules for In Vitro Diagnostic Medical Devices | IVDR | Rev. 4 March 2025 | Read our guide → |
| MDCG 2021-6 | Questions & Answers Regarding Clinical Investigation | MDR | Rev. 1 December 2023 | Read our guide → |
| MDCG 2020-10/1 | Safety Reporting in Clinical Investigations of Medical Devices | MDR | Rev. 1 October 2022 | Read our guide → |
| MDCG 2023-4 | Medical Device Software & Hardware Combinations | MDR / IVDR | Rev. 0 July 2023 | Read our guide → |
| MDCG 2020-5 | Clinical Evaluation — Equivalence | MDR | Rev. 0 April 2020 | Read our guide → |
| MDCG 2020-6 | Clinical Evidence for Legacy Devices | MDR | Rev. 0 April 2020 | Read our guide → |
| MDCG 2024-10 | Clinical Evaluation of Orphan Medical Devices | MDR | Rev. 0 2024 | Read our guide → |
| MDCG 2023-1 | Laboratory Developed Tests (LDTs) Under IVDR Article 5(5) | IVDR | Rev. 0 2023 | Read our guide → |
How We Help Manufacturers Navigate MDCG Requirements
We prepare Clinical Evaluation Reports structured to anticipate CEAR review criteria per MDCG 2020-13, integrating MEDDEV 2.7/1 Rev.4, MDCG 2020-5 (equivalence), and MDCG 2020-6 (legacy devices) into a single coherent document.
Our IVDR specialists apply MDCG 2020-16 classification rules across all IVD risk classes, from Class A specimen receptacles to Class D companion diagnostics. We document classification rationale as part of the technical file and maintain alignment with the latest revision.
We design and manage pre-market and post-market clinical investigations across multiple EU Member States, applying MDCG 2021-6 for regulatory pathway determination and MDCG 2020-10/1 for safety reporting. Our submissions follow MDCG 2021-8 templates.
For SaMD and AI-enabled devices, we apply MDCG 2023-4 (software-hardware combinations), MDCG 2019-11 (software classification), and the emerging EU AI Act framework to build regulatory strategies that address both MDR/IVDR and AI legislation requirements.
Frequently Asked Questions About MDCG Guidances
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Are MDCG guidance documents legally binding?
No. MDCG documents reflect a common interpretation of MDR and IVDR requirements, aiming at effective and harmonised implementation. However, Notified Bodies and competent authorities widely use them as key reference points during conformity assessments. As a result, manufacturers are generally expected to align with MDCG guidance when preparing their documentation for market access.
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How often are MDCG guidances updated?
MDCG documents are reviewed regularly. Some, like MDCG 2020-16 on IVD classification, have been revised four times since initial publication. Manufacturers should monitor updates through the European Commission’s Public Health portal and adjust their documentation and processes accordingly.
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Which MDCG documents are most important for medical device manufacturers under the MDR?
The most impactful documents for MDR compliance include MDCG 2020-13 (clinical evaluation), MDCG 2020-5 (equivalence), MDCG 2020-6 (legacy device evidence), MDCG 2021-6 (clinical investigations), and MDCG 2020-10/1 (safety reporting). Which documents are most relevant depends on your device class, regulatory status, and whether you are conducting clinical investigations.
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Which MDCG documents apply to IVD manufacturers under the IVDR?
For IVDR compliance, key documents include MDCG 2020-16 (classification rules), MDCG 2023-1 (LDTs and Article 5(5)), and MDCG 2022-20 (substantial modification of performance studies). IVD manufacturers involved in clinical performance studies should also reference MDCG 2021-6 Rev.1 for its general guidance on clinical investigation procedures.
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Where can I find the official MDCG documents?
All endorsed MDCG guidance documents are published on the European Commission’s Public Health website under “Guidance, MDCG endorsed documents and other guidance.” MDx CRO publishes practical breakdowns and manufacturer-focused analyses of the most relevant guidances on this page.
Need Help Interpreting MDCG Guidances for Your Device?
MDx CRO’s regulatory and clinical teams work with MDCG documents every day, from structuring CERs for Notified Body review to managing multi-country clinical investigations. Whether you need a gap assessment against a specific MDCG document or end-to-end regulatory support, we can help.
