EU IVDR requirements explained: video brief

Not in the sense of an ISO certificate. What the market requires is the CE mark, which the manufacturer affixes under its own EU declaration of conformity. For every class except plain class A, a notified body takes part and issues the certificates that declaration relies on. An "IVDR certificate" sold by a consultant or a management-system certification body is not one of them.

All class B, C and D devices, and class A devices placed on the market sterile. Plain class A devices, such as IVD instruments, specimen receptacles and certain general laboratory products, are self-declared. The class comes from the seven Annex VIII rules applied to the intended purpose, and deciding it is the manufacturer's responsibility.

No, although it is the right foundation. EN ISO 13485:2016 with A11:2021 was harmonised under the IVDR in 2022, which gives a presumption of conformity only for the requirements it addresses. Performance evaluation and PMPF, UDI, the PRRC, PSURs, vigilance reporting and EUDAMED sit outside it. Its certificate is issued under accreditation, not under a notified body designation.

Under Regulation (EU) 2024/1860, devices covered by a Directive 98/79/EC certificate and class D devices may stay on the market until 31 December 2027, class C devices until 31 December 2028, and class B and sterile class A devices until 31 December 2029. The conditions: continued compliance with the Directive, no significant change in design or intended purpose, no unacceptable risk, an Article 10(8) quality management system by 26 May 2025, an application by 26 May 2025 (certificate holders and class D), 26 May 2026 (class C) or 26 May 2027 (class B and sterile class A), and a written agreement with the notified body by 26 September of that year. IVDR surveillance, vigilance and registration rules already apply, and the sell-off date has gone.

They receive the closest scrutiny. Where the Commission has designated an EU reference laboratory for the device category, it verifies the performance claimed and tests batches; the first laboratories, designated by Implementing Regulation (EU) 2023/2713, took up these tasks on 1 October 2024 for markers of hepatitis and retrovirus, herpesvirus, bacterial and respiratory virus infections. Without a designated laboratory, notified bodies may still certify. Experts are consulted for a first-of-type device with no common specifications, and each batch is released through the notified body.