The New EU Framework for In Vitro Diagnostics Enters into Application

The In Vitro Diagnostics Regulation (IVDR, EU 2017/746) enters into application in the European Union (EU) on 26 May 2022.

What are the new requirements under the IVDR?

Following the Medical Devices Regulation last year, the entry into application of the IVDR brings significant changes to the framework of in vitro diagnostics (IVDs) in the EU, including:

• Introduction of a risk-based classification of IVDs
• More detailed description of essential requirements and increased role for common technical specifications
• Notified body (NB) conformity assessment for all IVDs except Class A non-sterile devices
• Special scrutiny mechanism for high-risk IVDs
• Increased requirements for performance studies and clarifications for clinical evidence
• Stricter post-market obligations
• Enhanced transparency and traceability through the database on medical devices (EUDAMED) and the unique device identifier (UDI)

How is IVDR being rolled out?

 To address the challenges of the IVDR implementation, including the limited number of NBs, the European Commission proposed a progressive roll-out of the IVDR. Regulation 2022/112, that entered into force on 28 January 2022, amends the transition periods as follows:

• Certificates for IVDs issued by a NB under the In Vitro Diagnostics Directive (IVDD) remain valid until the end of their validity period, but at the latest until 26 May 2025, provided that there are no significant changes in the design and intended purpose of those devices
• New transition periods for IVDs for which the IVDR introduces a conformity assessment involving a NB

The amended transition periods also impact the implementation of rules regarding the in-house device exemption.

26 May 2022 remains the general application date for the IVDR, in particular for CE-marked IVDs that do not require the involvement of an NB (i.e. Class A non-sterile devices) and IVDs not covered by a certificate or a manufacturer’s declaration of conformity issued prior to this date.

What else will change with IVDR?

Several initiatives will accompany the implementation of the IVDR:

• EUDAMED is expected to be fully functional in Q2 2023 and to go live in Q4 2023
• Adoption of additional harmonized standards on IVDs
• Guidance on topics such as post-market surveillance requirements, vigilance, importers and distributors, repackaging and relabeling and medical devices nomenclature

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