EU MDR：認証機関の選定

How do you pick a notified body? Under the MDR, most devices above Class I need one, as do sterile, measuring and reusable surgical Class I devices. But not every body can assess yours. Start in NANDO, the Commission's public list. A body's number alone proves little. For each body, check four things: the legislation, the conformity assessment procedures, the device codes it covers, and that its status is active, not suspended or withdrawn. As of October 2026, NANDO lists 52 notified bodies with an active MDR notification. Choose with care: you cannot apply to two of them in parallel for the same conformity assessment procedure. Once you are certified, the body's number follows your CE marking. But by drawing up the declaration of conformity, you, the manufacturer, take responsibility for compliance. Start with three things. One: confirm your MDR class first. Two: shortlist bodies whose NANDO scope covers your device codes. Three: declare any earlier application you withdrew, or one that was refused. Check the scope before you apply. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.