EU MDR：臨床評価報告書（CER）

What must your CER prove? Under the EU MDR, every manufacturer runs a clinical evaluation, Class I included, and keeps it current. So what goes into it? It starts with a clinical evaluation plan. Annex XIV sets the minimum, including the requirements that need clinical data, the intended purpose and target groups, the clinical benefits with outcome measures, and the criteria for an acceptable benefit-risk ratio. For implantable and Class III devices, clinical investigations are required, unless an exemption applies. Since July 2026, a longer list of well-established devices, such as guidewires and dental implants, can be exempt, if backed by sufficient clinical data. But they still need a clinical evaluation. And the report is never final. It is updated throughout the device's life, and for Class III and implantable devices, so is the PMCF evaluation report, at least annually. Start with three things. One: write the plan before you search the literature. Two: weigh favourable and unfavourable data alike. Three: feed every PMCF result back into the report. Plan it, prove it, update it. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.