CE marking for in vitro diagnostic devices done! With easyCE expert support.

The MDR replaced the AIMDD and MDD from 26 May 2021. The IVDR replaced the IVD directive from 26 May 2022, with conditional transitional arrangements for eligible legacy devices.

• Devices covered by qualifying IVDD certificates and eligible Class D devices: 31 December 2027.
• Eligible Class C devices: 31 December 2028.
• Eligible Class B and Class A sterile devices: 31 December 2029.

Conditions include continued IVDD conformity, no significant design or intended-purpose change, no unacceptable risk, and an IVDR quality management system by 26 May 2025. Notified-body application deadlines are 26 May 2025 for Class D, 26 May 2026 for Class C and 26 May 2027 for Class B and Class A sterile, followed by the corresponding written-agreement deadline of 26 September. Check the actual device’s certificate and transition eligibility.

The definition includes reagents, kits, calibrators, control materials, instruments, software and systems, as well as specimen receptacles. Examples include diagnostic test kits, blood glucose test systems and analysers with an IVD intended purpose. General laboratory or research-use products are not automatically IVDs.

This was not the current A-to-D risk classification. Notified-body involvement depended on the former category and procedure. When reviewing a legacy device, document both its former IVDD status and its classification under the IVDR.

Classes B, C and D require notified-body involvement. Class A non-sterile devices generally use manufacturer self-assessment; for Class A sterile devices, notified-body involvement is limited to the aspects concerning sterility.

Examples include tests for transmissible agents in blood or tissues intended for transfusion or transplantation and specified tests for life-threatening transmissible agents. ABO, Rhesus, Kell, Kidd and Duffy blood-grouping purposes are addressed by Rule 2. Classification depends on the exact intended purpose, not simply whether a disease is serious.

Devices for self-testing are generally Class C, except for the specific Class B exceptions. Near-patient testing is classified in its own right; it is not automatically one class.

The self-testing exceptions include pregnancy and fertility tests, cholesterol tests and tests for glucose, erythrocytes, leucocytes or bacteria in urine. These are diagnostic tests, not self-medication products.

An IVD intended purpose is essential. General laboratory equipment does not enter the IVDR merely because it is used in a laboratory. Class A sterile devices still require notified-body involvement for sterility aspects.

Record the applicable rules and the reasoning behind the classification. The assessment should begin before the documentation and test programme are fixed, so the necessary evidence is planned from the outset.

easyCE helps identify documentation gaps, assign evidence to the applicable requirements and prepare a clear assessment plan. Labels, packaging information and instructions must remain consistent with the intended purpose and supported performance claims.

The file should explain the design, intended purpose, manufacturing controls, risk management and performance evidence. Claims must be supported by suitable scientific validity, analytical performance and clinical performance evidence, as applicable.

Use controlled access, versioning and a reliable retrieval process. Retention should preserve the evidence for each device version, not merely the most recently edited file.

Create a requirements matrix stating which provisions apply and where the supporting evidence is held. These are regulatory requirements, not optional general principles.

Apply the requirements and implementation dates relevant to the device class and its regulatory status. The Basic UDI-DI is not the same as the UDI carrier placed on the label.

The actor registration, UDI/device registration, notified bodies and certificates, and market surveillance modules became mandatory to use from 28 May 2026, subject to the applicable transitional provisions. Other modules follow their own implementation timetable. Do not assume that all six modules became mandatory together.

It addresses scientific validity, analytical performance and clinical performance. Document the evaluation plan, evidence, conclusions and updates, including relevant post-market performance follow-up.

The IVDR requires a post-market surveillance plan. Classes A and B use a post-market surveillance report; Classes C and D require a periodic safety update report, updated at least annually. Post-market performance follow-up forms part of this continuing evidence process.

• Address the general safety and performance requirements and risk management.
• Prepare and maintain the performance evaluation and post-market plans.
• Appoint an authorised representative where required for a non-EU manufacturer.
• Obtain the required notified-body assessment, except for Class A non-sterile self-assessment.
• Issue the EU declaration of conformity, apply the required marking and fulfil the applicable registration obligations.

The central evidence concerns the validity and performance of the examination and the risks of incorrect results. Do not transfer an MDR device class, assessment route or clinical-document template without checking its relevance to the IVD.

The notified-body procedure is determined by the IVDR class and selected route. Certificate validity and surveillance follow the applicable scheme and certificate conditions; ISO 13485 certification is not universally reissued every year, and IVDR certificates do not have a universal three-year term.

Relevant standards depend on the product and task, including quality management, risk management and performance or labelling requirements. A fixed count of harmonised standards quickly becomes outdated. The technical file should identify the edition actually used and explain any alternative solution.

Article 15 sets qualification and availability requirements. Micro and small enterprises can have the PRRC permanently and continuously at their disposal rather than within the organisation.

The representative performs the tasks specified by Article 11, including keeping required documentation available and cooperating with authorities. This role does not transfer the manufacturer’s design and manufacturing responsibilities.

It assesses the relevant quality system and technical evidence and issues the applicable certificates where the requirements are met. The manufacturer remains responsible for the device’s conformity and safety. Select a body whose notified scope covers the product and required assessment.