MDCG: EU 의료기기 가이던스

What is the MDCG, and is it binding? It endorses most official guidance on the MDR and IVDR, from classification to clinical evaluation. So who is behind it? The MDCG was set up by Article 103 of the MDR. Member States appoint members who represent their competent authorities, and a Commission representative chairs, without a vote. Its work runs through 13 subgroups, and 11 of them also include stakeholder associations. Read MDCG guidance for what it is. The Commission says it is not legally binding: it presents a common understanding of how the MDR and IVDR should apply. Only the EU Court of Justice gives binding interpretations. And guidance changes. The classification guidance, MDCG 2021-24, was revised in April 2026, updating its tables for several rules. Check the revision before you rely on any document. Start with three things. One: download guidance only from the Commission's page. Two: record each document's number, revision and date. Three: start from the regulation, then apply the guidance. Read the law, then the guidance. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.