Medical Device Coordination Group Guidance
Guidance documents from the EU-level expert group that interpret MDR/IVDR requirements.
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. The Medical Device Coordination Group is set up under MDR Article 103 and consists of representatives from each EU member state, chaired by the European Commission. It works through subgroups on topics such as clinical investigation, notified bodies, borderline products, IVDs, new technologies and cybersecurity. MDCG guidance documents are not legally binding but are widely used by notified bodies and competent authorities.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.
- •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
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsMore in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1MDCG GuidanceTier 2 VerifiedEuropean Commissionhealth.ec.europa.eu
- 2RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
- 3FDA - Medical DevicesTier 2 VerifiedFDAfda.gov
Inline markers like [1] jump to the matching reference above.