MDCG guidance documents are non-binding guidance issued by the Medical Device Coordination Group to explain how the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) should be applied in practice. Manufacturers, notified bodies, and competent authorities use them to reach a common, harmonized interpretation across the EU.
What is MDCG guidance?
The Medical Device Coordination Group (MDCG) is the expert body set up under Article 103 of the EU MDR 2017/745. It brings together representatives from every EU Member State and is chaired by the European Commission. One of its main outputs is a series of guidance documents that explain how specific requirements of the MDR and IVDR should be read and applied.
Each document follows a fixed naming pattern: “MDCG Year-Number-revision.” MDCG 2025-10, for example, is the tenth document endorsed in 2025. These documents sit alongside the regulations rather than inside them. They do not change the legal text, but they tell manufacturers and notified bodies what regulators expect to see in practice.
Why MDCG guidance matters in medical device development
The MDR and IVDR are long and, in places, open to interpretation. MDCG guidance fills that gap. Notified bodies lean on these documents during conformity assessment, so a technical file that ignores current guidance is more likely to draw findings or follow-up questions. For a manufacturer chasing CE marking, that can mean lost weeks or a stalled launch.
The guidance also shapes day-to-day quality and clinical work. Documents on clinical evaluation, post-market surveillance (PMS), and vigilance set the bar for what good evidence and reporting look like. A clinical evaluation report (CER) or PMS plan written without reference to the relevant MDCG document risks being judged incomplete, even when it meets the letter of the regulation.
How MDCG guidance works
MDCG documents are endorsed under Article 105 of the MDR and Article 99 of the IVDR. They carry real weight with regulators, but they are not law. The standard disclaimer in each document states that the views are not legally binding and that only the Court of Justice of the European Union can give binding interpretations.
A few features are worth knowing:
Scope
Documents cover the full device lifecycle, from classification and clinical investigation through PMS, vigilance, and EUDAMED registration.
Numbering
The “Year-Number-revision” format makes versions easy to track. A “rev1” or “rev2” suffix signals an update, so always confirm you are citing the current revision.
Source
The European Commission publishes the endorsed list on its public health pages. Obsolete documents are archived rather than deleted.
Status
Each document reflects a common position agreed by Member States, which is why notified bodies treat it as the practical benchmark.
Recent additions show how the guidance keeps moving. MDCG 2025-10, published in December 2025, reframes PMS as a proactive, data-driven system that feeds clinical evaluation and risk management, rather than a complaint-driven afterthought.
Common challenges and best practices
The most common mistake is treating MDCG guidance as optional. Teams read the regulation, build their files, and then learn during the audit that a notified body expected alignment with a specific document. Another trap is citing a superseded revision after a newer version has been endorsed.
Good practice is straightforward. Keep a watch list of documents relevant to your device class and pathway. Map each one to the affected part of your technical documentation, so an update to, say, the PMCF template flows through to your actual plan. Review the endorsed list on a regular schedule, and record which revision you relied on for each deliverable. Where guidance and regulation appear to differ, the regulation wins, and the difference is worth raising with your regulatory lead.
How SJML helps with MDCG guidance
Syrma Johari MedTech (SJML) offers Compliance-as-a-Service that builds current MDCG guidance into EU MDR and IVDR programs. The QARA team supports device classification, technical files and DHF, CE marking and registration, clinical evaluation (CEP, CER, SSCP), and post-market surveillance and vigilance (PMS, PMCF, PSUR, FSCA), keeping each deliverable aligned with the relevant endorsed document and its latest revision. SJML also supports EUDAMED readiness and QMS work to ISO 13485 and ISO 14971, so guidance changes flow through to your files without surprises at audit.
Frequently asked questions
No. MDCG guidance documents are not legally binding. Each one states that only the Court of Justice of the European Union can give binding interpretations of EU law. In practice, though, notified bodies and competent authorities treat the guidance as the expected way to apply the MDR and IVDR, so most manufacturers follow it closely to avoid findings during conformity assessment.
Both terms get used, but the European Commission calls them MDCG-endorsed documents or MDCG guidance. People often say MDCG guidelines informally. They refer to the same set of documents: non-binding guidance that explains how to apply the MDR and IVDR. When searching or citing, MDCG guidance plus the specific document number, such as MDCG 2025-10, is the more precise reference.
MDCG documents use a Year-Number-revision format. MDCG 2024-1 is the first document endorsed in 2024. A revision suffix, such as rev1 or rev2, marks an updated version, so the same topic may carry a new revision over time. Always confirm you are citing the current revision on the Commission’s endorsed documents page, because earlier versions are archived once superseded.
Several do.
Clinical evaluation
MDCG 2020-13 covers CER assessment.
MDCG 2020-5 and MDCG 2020-6 address equivalence and clinical evidence for legacy devices.
Post-market surveillance
MDCG 2025-10 covers PMS.
MDCG 2020-7 and MDCG 2020-8 provide PMCF plan and evaluation report templates.
Vigilance
MDCG 2023-3 and the device-specific vigilance templates.
Check for newer revisions before relying on any of them.
Related terms
- EU MDR (Regulation 2017/745)
- Clinical Evaluation Report (CER)
- Post-Market Surveillance (PMS)
- Post-Market Clinical Follow-up (PMCF)
- EUDAMED
