Drugdu.com expert's response:

For enterprises preparing to export products such as pregnancy test strips, urine test strips, and infectious disease self-test kits to the EU, IVDR CE conformity assessment is a critical step to enter the EU market. Compared with in vitro diagnostic reagents mainly used by laboratory professionals, self-test products also need to consider whether ordinary consumers can correctly operate and interpret test results, as well as the health risks that may arise from improper use.

The EU Regulation on In Vitro Diagnostic Medical Devices (EU) 2017/746, known as IVDR, has been applicable since May 26, 2022. This regulation sets requirements for the classification, performance evaluation, technical documentation, quality management system and post-market surveillance of IVD products. When enterprises apply for IVDR CE-related certificates, they need to pay special attention to the following aspects.

First, it is necessary to confirm whether the product is a self-testing IVD and its corresponding risk class.

The Self-testing Device referred to in IVDR generally refers to in vitro diagnostic medical devices that the manufacturer intends for non-professionals to use on their own, including some products that ordinary users complete testing with in home environments.

According to Classification Rule 4 in Annex VIII of IVDR, self-testing IVDs are in principle Class C. However, specific products such as pregnancy tests, fertility tests, cholesterol determination, and tests for glucose, red blood cells, white blood cells and bacteria in urine can be classified as Class B. If a product also meets other higher-risk classification rules, the final class shall be determined in accordance with the applicable classification rules.

Therefore, enterprises cannot simply classify all household self-test reagents into Class B. For example, household pregnancy test strips usually belong to Class B, while some infectious disease self-test kits may fall into Class C or Class D, depending on the test purpose, target disease and relevant classification rules. The classification result will directly affect the scope of Notified Body review, technical documentation requirements and conformity assessment procedures.

Self-test products also need to demonstrate that ordinary users can use them correctly.

This is a key difference that requires attention between self-test reagents and professional laboratory-use IVD products.

Laboratory testing is usually completed by trained professionals, while users of household self-test reagents may have no medical or laboratory operation experience. Sampling methods, sample addition volume, operation time, result interpretation and handling of abnormal results may all affect the final test results.

For example, a colloidal gold self-test kit has good testing performance under laboratory conditions. However, if ordinary users frequently make mistakes in sample addition, inaccurate reading time, or cannot identify weak positive results, the safety and effectiveness of the product in actual use may be compromised.

Therefore, enterprises need to carry out appropriate usability studies and user use verification for the intended user population, to prove that ordinary users can complete the operation according to the instructions and correctly understand the test results. Section 5.1 of Annex IX of IVDR clearly requires that the technical documentation review of self-test products shall include the results of intended user studies and relevant data proving that the product is suitable for self-testing purposes.

Performance evaluation data must match the self-testing intended use.

IVDR requires manufacturers to establish a performance evaluation system, form corresponding evidence around scientific validity, analytical performance and clinical performance, and compile a performance evaluation report.

For self-test reagents, in addition to paying attention to applicable indicators such as test sensitivity, specificity, accuracy, repeatability, limit of detection and interfering factors, enterprises also need to consider the product's performance under the operation of ordinary users.

For example, the performance data obtained when operated by professionals may not fully prove that ordinary users can achieve the corresponding performance when using the product in a home environment. Different sample collection methods, environmental conditions and result interpretation methods may all affect the test results.

Enterprises need to combine the intended use of the product to judge whether it is necessary to supplement performance studies or clinical performance studies for the self-test scenario, and ensure that the research data can support the performance claims in the instructions and product promotion.

Labels and instructions need to be understandable to ordinary users.

The instructions for self-test reagents cannot be directly copied from the professional laboratory version.

In accordance with the requirements of Annex I of IVDR, the information provided for self-test products shall be suitable for the intended users, explaining how to correctly collect samples, complete the test, read the results, and how to deal with invalid results.

For products that may produce false positive or false negative results, relevant limitations, possible influencing factors and necessary follow-up measures should also be appropriately explained, to prevent users from making inappropriate medical decisions based on a single test result.

If the product is planned to be sold in EU member states such as France and Germany, it is also necessary to confirm the applicable language requirements for labels and instructions in the target sales countries. Even if the same product has completed CE conformity assessment, it cannot be assumed that it can be sold in the entire EU market only with English instructions.

In addition, the content of packaging, storage conditions, shelf life, batch number, manufacturer information, etc. also needs to be consistent with the technical documentation and the actual product.

Notified Body review and quality management system cannot be ignored either.

According to IVDR, Class B, C and D in vitro diagnostic medical devices usually require the Notified Body to participate in conformity assessment. For self-test products, in addition to the applicable conventional audit procedures, the technical documentation review related to the self-testing purpose shall be accepted in accordance with Section 5.1 of Annex IX.

Enterprises usually need to prepare product description, intended use, risk classification basis, design and manufacturing documents, applicable General Safety and Performance Requirements (GSPR) conformity evidence, performance evaluation reports, risk management documents, label instructions and relevant verification reports.

At the same time, manufacturers need to establish a quality management system that meets the requirements of IVDR, covering activities such as design and development, production control, supplier management, product release, complaint handling and post-market surveillance. ISO 13485 certification can provide support for the quality management system, but the ISO 13485 certificate alone cannot replace IVDR conformity assessment.

For Chinese manufacturers, it is also necessary to appoint an EU Authorized Representative in accordance with regulations, and clarify the responsibilities of economic operators such as the manufacturer, Authorized Representative and importer. When products enter the EU market, they should also meet the applicable UDI, registration and traceability requirements.

After obtaining the CE certificate, continuous post-market surveillance is also required.

Self-test reagents directly face ordinary users, so post-market complaints, misoperations, abnormal test results and potential safety events are worthy of continuous attention.

IVDR requires manufacturers to establish a Post-Market Surveillance (PMS) system, and fulfill corresponding reporting and performance tracking obligations according to the product risk class, including conducting Post-Market Performance Follow-up (PMPF) when applicable.

For self-test reagents, enterprises can focus on user operation errors, result misinterpretation, false positive or false negative feedback, product batch problems, and whether there are easily misleading contents in the instructions. Relevant information needs to be incorporated into risk management, performance evaluation and necessary product improvement work.

In addition, the EU has adopted Regulation (EU) 2024/1860 to adjust the transition arrangements for some existing IVD products. Eligible existing products may benefit from an extended transition period, but newly developed products cannot directly apply these arrangements. As of November 2026, enterprises should specially check whether their products meet the transition conditions, as well as the corresponding deadline requirements for Notified Body applications and written agreements.

For self-test IVD enterprises preparing to enter the EU market, when applying for IVDR CE-related certificates, the most important things to confirm in advance are product classification, Notified

Body audit path, performance evaluation evidence, and whether the verification of ordinary user use is sufficient.

In particular, for enterprises that have obtained old IVDD-related certificates and are preparing to transition to IVDR, they should recheck whether the existing performance data, instructions, risk management and technical documents meet the requirements of the new regulation, and cannot simply assume that all original test reports and certification materials can be reused.

For enterprises that develop overseas buyers through pharmaceutical and medical device B2B platforms such as Drugdu.com, it is also recommended to accurately state the product's intended use, target user group, IVDR classification, certification status and the scope of technical documents that can be provided in the product display. For products that are still in the process of conformity assessment, the progress should be truthfully stated, avoiding describing certificates under application as already obtained.

The regulatory focus of EU self-test reagents, in addition to the product's own testing performance, also includes whether ordinary users can complete the test safely and accurately. Enterprises need to integrate the self-test use scenario into product design, risk management, performance evaluation, label instructions and post-market surveillance, so as to provide sufficient support for IVDR conformity assessment and subsequent EU market sales.