European and International standards

Medical-device regulations and technical standards have different roles. Start with the product's intended purpose and regulatory classification, then identify the requirements and evidence relevant to that device. Use the correct EU references The Medical Devices Regulation is Regulation (EU) 2017/745 , usually called the MDR. The In Vitro Diagnostic Medical Devices Regulation is Regulation (EU) 2017/746 , or IVDR. The European Commission's regulatory overview provides the framework and links to further guidance. What harmonised standards contribute A standard is not automatically a harmonised reference for a regulation because it concerns healthcare. The Commission publishes references in the EU Official Journal. Voluntary use of a cited standard can provide presumption of conformity for the requirements it covers, within the applicable citation and its limits. Check the Commission's medical-device harmonised-standards page for the relevant regulation and publications. ...

In the EU framework, harmonised standards are developed by recognised European standardisation organisations in response to a Commission request. Their role should be assessed against the specific legislation and published references. What the citation contributes For the applicable framework, use of a cited standard can support presumption of conformity with the requirements it covers. This is limited to the relevant requirements, edition and citation conditions. It is not a blanket declaration that a product complies with every applicable law. The European Commission's harmonised-standards overview explains the relationship between voluntary technical standards and mandatory legal requirements. Use a four-part check Legislation: identify which requirements apply to the product and its intended use. Document: record the full standard designation, edition and amendments. Citation: confirm the relevant EU Official Journal reference, restrictions and any applicable dates. Evidenc...