EU MDR Clinical Evaluation Routes: Equivalence, WET, Legacy & More

Clinical Evaluation Routes and Methods in MDR Certification – Figure 1

Under the EU Medical Device Regulation (MDR 2017/745), all medical devices must undergo clinical evaluation before being placed on the market to demonstrate that they meet the general safety and performance requirements. The MDR sets out multiple clinical evaluation routes, allowing manufacturers to choose the best option for their device. Drawing on MDR 2017/745 and documents published by the Medical Device Coordination Group (MDCG) such as MDCG 2020-6, MDCG 2023-6 and MDCG 2023-7, this article analyses the clinical evaluation routes and methods in MDR certification in detail.

Clinical Evaluation Routes and Methods in MDR Certification – Figure 2

Types of clinical evaluation routes

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Equivalence route

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Scope: applicable to all medical devices. Equivalence with a device already on the market must be demonstrated in terms of technical, biological and clinical characteristics.
Technical: design, materials and manufacturing processes must be the same or similar.
Biological: biocompatibility, toxicity and degradation characteristics must be consistent.
Clinical: no significant differences in intended purpose, patient population, clinical performance, etc.

Route exempt from clinical investigation

Clinical Evaluation Routes and Methods in MDR Certification – Figure 5

Scope: implantable or Class III devices that are modifications of a device already marketed by the same manufacturer, such as material upgrades or structural optimisation.
Demonstrating equivalence: equivalence with the original device must be shown in technical, biological and clinical characteristics.
Post-market clinical follow-up (PMCF): a PMCF plan must be drawn up to continuously monitor post-market data.

Equivalence with another manufacturer’s device

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Scope: implantable or Class III devices.
Special requirement: when comparing with an equivalent device from another manufacturer, a contract must be in place to ensure access to the equivalent device’s technical documentation.

Legacy device route

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Scope: implantable or Class III devices certified under the MDD (Medical Devices Directive) or the AIMDD (Active Implantable Medical Devices Directive).
Clinical evidence requirement: PMCF data must be updated and integrated to demonstrate compliance with the MDR.

Well-established technology route

Clinical Evaluation Routes and Methods in MDR Certification – Figure 8

Scope: specific medical devices such as sutures, dental fillings, screws and bone plates.
Historical data requirement: a market safety record of at least 5–10 years must be provided, and clinical data on similar products may be cited. Where common specifications (CS) exist, compliance must be verified by testing.

Non-clinical data route

Clinical Evaluation Routes and Methods in MDR Certification – Figure 10

Scope: low-risk devices such as laboratory equipment and non-invasive tools.

Special requirement: a thorough justification of why clinical data are not needed must be provided.

Steps for implementing an exemption from clinical investigation

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Determine the route: identify the exemption route and the applicable Article.
Collect evidence: gather equivalence data, draw up the PMCF plan and other supporting evidence.
Prepare documentation: prepare the Clinical Evaluation Report (CER), risk management documentation and other necessary documents.
Notified body review: submit the documentation for review by the notified body (NB).
Post-market surveillance: implement the PMCF plan and update the CER regularly.

Key document checklist

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Technical documentation (TCF): comprehensive information on the device’s technical aspects.
Clinical Evaluation Report (CER): the core document summarising the clinical evaluation process and results.
Post-market clinical follow-up plan (PMCF plan): the plan guiding post-market data monitoring.
Risk management documentation: records of the device’s risk management process.

Clinical Evaluation Routes and Methods in MDR Certification – Figure 13

Clinical Evaluation Routes and Methods in MDR Certification – Figure 14

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Introduction to EU MDR Class I Products

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EVERBIZ Certification Services (Shanghai) Co., Ltd. (EVERBIZ) is a professional compliance service platform for testing, certification, consulting and training of medical products, dedicated to helping leading medical R&D companies at home and abroad improve their compliance capabilities and competitiveness. The company has offices and branches in Shanghai (China), Hong Kong, Munich (Germany), Salzburg (Austria) and Thailand, covering nearly 25 industries of compliance products (such as medical devices, new energy, household appliances, lighting, tools, laboratory instruments, machinery, in vitro diagnostics, wireless products and reagents).

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Clinical Evaluation Routes and Methods in MDR Certification – Figure 18