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Medical Device Coordination Group Guidance
Guidance documents from the EU-level expert group that interpret MDR/IVDR requirements.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
The MDCG, composed of competent authority representatives, issues numbered guidance documents (MDCG 2019-x, MDCG 2021-x, etc.) covering classification, clinical evaluation, vigilance, software, AI, and many other MDR/IVDR topics. What the regulation says
The Medical Device Coordination Group (MDCG) is an expert group established under Article 105 of the EU Medical Device Regulation (MDR) and Article 99 of the EU In Vitro Diagnostic Regulation (IVDR). While MDCG guidance documents are not legally binding, they represent the common understanding and interpretation of the regulations by EU member states and the European Commission, serving as de-facto standards for compliance.
What this means in practice
MDCG documents are not legally binding but set the de-facto interpretive baseline for Notified Bodies and competent authorities; ignoring them is risky.Examples
- A manufacturer consults MDCG 2019-11, Guidance on Qualification and Classification of Software, to determine the correct classification of their new diagnostic mobile application under the EU MDR.
- During a Notified Body audit, the auditor references MDCG 2020-13, Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, to assess the adequacy of a device's Clinical Evaluation Report (CER).
- A company preparing a Post-Market Surveillance (PMS) plan reviews MDCG 2022-21, Guidance on Post-Market Surveillance (PMS) Plan for Manufacturers and other economic operators, to ensure all required elements are included.
Common pitfalls
- •Ignoring MDCG guidance can lead to non-conformities during audits or market access delays, even though the guidance is not legally binding.
- •Misinterpreting the scope or applicability of a specific MDCG document can result in misallocation of resources or incomplete compliance efforts.
- •Failing to track updates or new MDCG documents can leave a manufacturer unaware of evolving regulatory expectations.
- •Assuming national competent authorities will always align their interpretation perfectly with MDCG guidance without further clarification can lead to errors.
- •Treating MDCG guidance as optional rather than an integral part of interpreting and applying the MDR/IVDR is a common pitfall.
Frequently asked questions
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Cited by
Where this term appears across MedTech Terms.
Ecosystems (2)
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
European Commission·1RAPS·1FDA·1
- 1
MDCG GuidanceVerifiedEuropean Commissionhealth.ec.europa.eu
- 2
RAPS Regulatory FocusVerifiedRAPSraps.org
- 3
FDA - Medical DevicesVerifiedFDAfda.gov
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