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. ...

When specifying packaging for terminally sterilised medical devices, identify the full document designation. A base standard, a separate amendment and a consolidated national publication are different purchasing and reference options. What the amendment addresses ISO 11607-1:2019/Amd 1:2023 adds risk-management application to the Part 1 requirements for materials, sterile barrier systems and packaging systems. ISO records its publication in September 2023. A national adoption can have a different publication date. The EVS record for EN ISO 11607-1:2020/A1:2023 identifies an amendment publication. It should not be described as a new standalone edition containing the entire base standard. Check what your copy contains Confirm the base standard and all applicable amendments. Check whether the supplied document is amendment-only or consolidated. Distinguish European additions, such as an A11 amendment, from the international Amd 1. Record the publication actually used in the assessment a...

ISO 13485 specifies requirements for a quality management system in the medical-device field. Its focus is how an organisation manages relevant processes; a certificate against the standard is not a universal product approval. Start with the organisational scope ISO's publication record identifies ISO 13485:2016 as the current edition, reviewed and confirmed in 2025. Organisations involved in device design, production, installation, servicing and related supply activities can have relevant responsibilities within its scope. Define which activities, sites and services the organisation's system covers. Then connect procedures and records to the work actually performed. A supplier carrying out a limited activity should not imply that its certificate covers the entire device lifecycle. Three things to check in a certification claim The organisation and locations named on the certificate. The activities and scope covered by the assessment. The applicable standard, certificate statu...