IVDR: Klassen A–D und Übergangsfristen

Which IVDR class is your test? Annex VIII sorts every IVD into class A, B, C or D. And for many legacy devices, that class now sets the deadline. If your self-declared IVDD device now needs a notified body, its class sets how long it may still be placed on the market. Class D: until December 31, 2027. Class C: the end of 2028. Class B and sterile class A: the end of 2029. Conditions apply: the device still complies with the IVDD, with no significant change in design or intended purpose. An IVDR quality system in place by May 2025. And a notified body application and signed agreement on time. For class D and C, the deadlines to apply and sign have passed. For class B and sterile class A, apply to a notified body by May 26, 2027, and sign the agreement by September 26, 2027. Start with three things. One: classify each IVD against all seven rules. Two: use MDCG 2020-16, now in revision 5. Three: lock in your notified body before the 2027 dates. Know your class. Watch the clock. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.