EU IVDR CE Marking: Requirements & Legacy Deadlines

EU IVDR CE marking: qualification and route

The EU IVDR governs covered in vitro diagnostic devices. Use this guide for CE marking within that framework. Start by documenting intended purpose, analyte/marker, specimen, population, clinical function, operator and setting. Confirm that the product qualifies as an IVD, then apply Annex VIII classification under the IVDR.

Confirm the body’s IVDR designation and device scope using Notified Body selection. Certification by an ISO auditor alone is not IVDR conformity assessment.

Evidence and documentation before marking

Map the applicable Annex I GSPRs to controlled evidence. Prepare Annex II/III technical documentation, risk management, labeling and a performance-evaluation plan/report addressing scientific validity, analytical performance and clinical performance. The PER guide explains those separate elements.

Implement the Article 10 QMS, PRRC, EU AR where needed, supply-chain controls, UDI and applicable registration. ISO 13485 is a common QMS framework; a certificate does not replace all IVDR duties. Class A non-sterile is not exempt from a functioning QMS.

Complete the applicable conformity assessment and obtain required certificates. The manufacturer then finalizes and signs the EU Declaration of Conformity before affixing CE marking. Use the Notified Body identification number where required and complete EUDAMED registration under the applicable timing rules.

Legacy IVDs: verify eligibility, not only the end date

Eligible Class D legacy devices may have an end date of December 31, 2027; Class C December 31, 2028; Class B and A sterile December 31, 2029. These depend on Article 110 conditions, including QMS, application and written-agreement milestones, continued directive compliance and restrictions on significant changes.

The Commission transition page and IVDR hub set out the milestones. Class A non-sterile and new devices cannot simply claim the same extension. Continued availability of units already lawfully placed is a different question from placing further units on the market.

Maintain conformity after launch

Operate PMS, PMPF, vigilance and changes under the QMS. Class A/B generally use a PMS Report; Class C/D use an annual PSUR. Update the PER, risk file and labels when evidence changes. Pure Global can coordinate the route, gap assessment, evidence plan and Notified Body preparation within the device’s actual scope.