欧盟MDR PMCF：计划、报告与时限

Does your device need PMCF? Under the EU MDR, every device needs a PMCF plan, or a justification for why PMCF does not apply. So what does PMCF actually do? PMCF is a continuous process that updates your clinical evaluation. You proactively collect clinical data from the device on the market, to confirm its safety and performance over its expected lifetime, and to detect emerging risks. How often? For Class III and implantable devices, the PMCF evaluation report must be updated at least once a year. The MDCG templates are 2020-7 for the plan, and 2020-8 for the report. And the findings travel. They feed your clinical evaluation and your risk management, and for Class IIa, IIb and III devices, the main findings also go into the PSUR. Start with three things. One: set PMCF objectives from your clinical evidence gaps. Two: if PMCF does not apply, justify it in the PMS plan. Three: schedule every PMCF evaluation report. Plan it, or justify it. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.