EU MDR: 의료기기 품목 분류 규칙

Which MDR class is your device? The answer sets your route to the CE mark, and whether a notified body is involved. Four classes, twenty-two rules. Annex VIII of the MDR sets out 22 rules, grouped for non-invasive, invasive and active devices, including Rule 11 for software, plus special rules. If several rules apply to your device, the strictest one, giving the higher class, decides. Key inputs include the intended purpose, the duration of continuous use, how invasive the device is, and whether it is active. Transient means under 60 minutes; long term means over 30 days. And for legacy devices, the MDR class sets the deadline: December 31, 2027, for Class III and most implantable Class IIb devices, and December 31, 2028, for the rest. Start with three things. One: write the intended purpose first. Two: run every rule against it, and keep the strictest. Three: check MDCG 2021-24, revised in April 2026, for examples. Purpose first, then the rules. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.