MDCG Guidance: EU MDR & IVDR Framework

MDCG guidance documents represent the official technical and regulatory interpretations endorsed by the European Union’s Medical Device Coordination Group to ensure the harmonized implementation of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). For medical device developers, clinical researchers, and regulatory sponsors working to understand what is a medical device under EU regulations, these publications outline the practical assessment criteria applied by notified bodies and competent authorities across EU Member States.

What it is and who runs it

The Medical Device Coordination Group (MDCG) is an expert regulatory body established pursuant to Article 103 of Regulation (EU) 2017/745 and Article 98 of Regulation (EU) 2017/746. It is composed of representatives designated by each EU Member State, possessing recognized expertise in medical devices and in vitro diagnostics. The European Commission provides the group’s secretariat and chairs its meetings.

Under Article 105 of the EU MDR, the MDCG is tasked with advising the European Commission, monitoring notified body designations, coordinating market surveillance activities, and issuing consensus guidance documents. These guidance documents establish a common understanding across national competent authorities and conformity assessment bodies. Although MDCG documents are legally non-binding administrative guidance rather than primary legislative acts, notified bodies treat them as the authoritative benchmark during conformity assessments and technical audits, as described on the official page on 2026-11-07.

Eligibility (summary, with the official source)

MDCG guidance applies broadly to all economic operators and entities operating within the scope of EU MDR and EU IVDR, as detailed in the official European Commission repository on 2026-11-07. Eligible stakeholders governed by these documents include:

Medical Device and IVD Manufacturers: Commercial entities and academic institutes manufacturing devices marketed or used in clinical investigations within the European Union.
Authorised Representatives: Natural or legal persons established in the Union who act on behalf of non-EU manufacturers under an EU authorised representative MDR Article 11 mandate.
Notified Bodies: Conformity assessment organizations designated under MDR/IVDR to audit technical files and quality systems.
Clinical Investigators and Sponsors: Academic health centers, contract research organizations, and institutional sponsors conducting clinical investigations under ISO 14155 and MDR Chapter VI.

What it funds or requires

MDCG guidance does not provide direct financial grant funding; instead, it establishes mandatory operational criteria, dossier architectures, and verification standards required to achieve and maintain CE mark certification. Key requirements defined across the guidance corpus include:

Clinical Evaluation and Performance: Guidance series such as MDCG 2020-1 (covering clinical evaluation of medical device software) and MDCG 2020-5 define rigorous standards for establishing valid clinical associations, technical verification, and clinical performance in a clinical evaluation report under EU MDR.
Classification and Borderlines: Documents like MDCG 2021-24 elaborate on how to apply the 22 classification rules in Annex VIII, ensuring consistent classification under the EU MDR classification rules.
Notified Body Auditing: Notified body guidance sets standardized audit checklists and technical documentation sampling rules across device risk classes, including specific benchmarks for Class IIa medical device requirements EU MDR.
Traceability and Identification: Detailed guidance establishes the allocation and management of the Basic UDI-DI and device registration within EUDAMED databases.
Post-Market Surveillance and Vigilance: Templates and timetables for Periodic Safety Update Reports (PSUR), Post-Market Clinical Follow-up (PMCF) plans, and manufacturer incident reports.

Application or compliance steps

To incorporate MDCG guidance into a medical device compliance management plan, regulatory teams should follow six systematic steps:

Identify Relevant Working Group Series: Map the device’s technical characteristics against MDCG specialized working groups, including Clinical Investigation and Evaluation (CIE), Borderline and Classification, New Technologies, and Post-Market Surveillance.
Cross-Reference Specific Guidance Numbers: For specialized device categories such as software, retrieve targeted guidance such as MDCG 2020-1 to determine evidentiary requirements for valid clinical association and technical verification.
Incorporate Expectations into Design and Development: Update design control procedures, risk management files, and clinical investigation plans to align with the active MDCG interpretations before initiating formal verification testing.
Align Technical Documentation: Format Summary of Safety and Clinical Performance (SSCP), CER, and PMS documentation to match the endorsed MDCG templates and structural expectations.
Engage with the Notified Body: Submit conformity assessment documentation structured in accordance with relevant MDCG guidance to minimize audit deficiencies and technical non-conformities.
Monitor Ongoing Guidance Revisions: Track the European Commission guidance repository periodically for revision notices, endorsed endorsements, or updated question-and-answer documents.

Typical timeline phases (no calendar dates as facts)

Compliance with MDCG guidance progresses through several recurring operational phases across the lifecycle of a medical device:

Concept and Classification Phase: Regulatory teams assess device characteristics against MDCG classification and borderline guidance to determine risk classification and conformity assessment routes.
Pre-Clinical and Clinical Verification Phase: Developers establish clinical evaluation plans and execute software or bench verification based on specific MDCG validation protocols (such as MDCG 2020-1 for software algorithms).
Dossier Assembly and Submission Phase: Technical documentation is prepared using endorsed MDCG structure formats, including SSCP drafting and Basic UDI-DI generation.
Conformity Assessment and Audit Phase: The designated notified body audits the manufacturer’s technical documentation against current MDCG review standards and issues requests for additional evidence if gaps are identified.
Post-Market Lifecycle Phase: Manufacturers execute continuous post-market surveillance, submit regular PSUR updates, and conduct PMCF activities aligned with MDCG post-market guidance.

Common mistakes

Medical device sponsors commonly encounter several avoidable errors when working with MDCG documents:

Treating Guidance as Optional: Assuming that because MDCG documents are non-binding in primary law, notified bodies will accept alternative methodologies without exhaustive scientific justification.
Using Outdated Directives Guidance: Relying on legacy MEDDEV guidance documents when an active MDCG guidance document has replaced the earlier standard under the MDR.
Overlooking Specific Sub-Series Guidance: Preparing clinical evaluations for software without adhering to the three-pillar framework (valid clinical association, technical performance, clinical performance) established in MDCG 2020-1.
Failing to Monitor Revisions: Neglecting periodic updates on the European Commission portal, resulting in technical documentation submitted against withdrawn or updated document revisions.
Inadequate Clinical Equivalence Documentation: Attempting to claim clinical equivalence under MDR Article 61 without satisfying the strict biological, technical, and clinical criteria detailed in MDCG 2020-5.

Related programs (table)

Framework / Program	Governing Body	Primary Scope	Legal Standing
MDCG Guidance	Medical Device Coordination Group / European Commission	Implementation guidance for EU MDR and EU IVDR	Non-binding consensus guidance; audit benchmark
FDA Guidance Documents	U.S. Food and Drug Administration (CDRH/CBER)	Recommendations for compliance with U.S. 21 CFR device regulations	Non-binding recommendations representing agency current thinking
IMDRF Technical Documents	International Medical Device Regulators Forum	Global regulatory convergence and harmonized device definitions	Voluntary international guidance adopted by member jurisdictions
Legacy MEDDEV Guidance	European Commission (pre-MDR)	Guidance for legacy Directives 93/42/EEC and 90/385/EEC	Superseded where replaced by active MDCG documents

FAQ

What is the legal status of MDCG guidance under EU MDR?

MDCG guidance documents are not legally binding legislative acts. However, because they reflect the consensus interpretation of EU Member States and the European Commission, notified bodies and national competent authorities treat them as authoritative practical benchmarks during audits and market surveillance.

How does MDCG 2020-1 apply to medical device software?

MDCG 2020-1 provides a dedicated framework for clinical evaluation and performance evaluation of medical device software (MDSW). It establishes that software developers must demonstrate valid clinical association, technical performance, and clinical performance to meet the General Safety and Performance Requirements under EU MDR and IVDR.

Where are new MDCG guidance documents published?

Official MDCG documents are published and regularly updated on the European Commission’s Public Health website within the dedicated Medical Devices Sector repository.

Sources

European Commission, Public Health, “Guidance – MDCG endorsed documents and other guidance,” https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en (read 2026-11-07).
EUR-Lex, “Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices,” Articles 103 and 105, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32017R0745 (read 2026-11-07).
European Commission, “MDCG 2020-1: Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software,” https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_1_guidance_clinic_eval_mdsw_en_0.pdf (read 2026-11-07).