Clinical evaluation is a key regulatory element for the CE marking of medical devices in Europe. It demonstrates that a medical device is clinically safe, effective, and has a positive risk-benefit ratio throughout its entire product life cycle.
Manufacturers are required to conduct a clinical evaluation for each medical device in accordance with the Medical Device Regulation (EU) 2017/745 (MDR). The requirements apply to all risk classes, with increasing depth and complexity for products in classes IIa, IIb, and III as well as for implantable devices.
WQS has been supporting manufacturers for over 30 years in the planning, implementation, and updating of clinical evaluations in a practical, regulatory-compliant, and audit-proof manner.
A clinical evaluation is a systematic and continuous collection, analysis, and assessment of clinical data to demonstrate the safety and clinical performance of a medical device.
The aim is to demonstrate that the medical device achieves the intended clinical performance, is suitable for its intended purpose, has an acceptable benefit-risk profile, and corresponds to the generally recognized state of the art.
For implantable medical devices and Class III products, a clinical trial is often required unless existing clinical data sufficiently demonstrate safety and performance.
According to the MDR, clinical data is based in particular on:
Article 10 of the MDR requires manufacturers to perform a clinical evaluation for all classes of medical devices (Class I, IIa, IIb, and III).
The regulatory requirements for clinical evaluation are specified in particular in:
In addition, recognized guidelines and interpretation aids apply, in particular:
These documents describe the structure, methodology, and content of an MDR-compliant clinical evaluation and serve to demonstrate the general safety and performance requirements in accordance with MDR Annex I, in particular Sections 1 and 8. Article 61 and Annex XIV also specify post-market clinical follow-up (PMCF) as part of post-market surveillance (PMS).
A clinical evaluation is mandatory for every medical device, regardless of its risk class (Class I, IIa, IIb, and III). It must be planned, documented, and updated throughout the entire product life cycle.
The need for an additional clinical investigation depends on the required level of evidence and possible gaps in the available clinical data.
A clinical investigation is required if the available clinical data is insufficient to demonstrate the clinical safety and performance of the medical device for its intended purpose. For implantable medical devices and Class III products, the MDR generally requires a clinical investigation, unless regulated exceptions apply, such as for certain legacy devices with sufficient clinical evidence.
Exceptions are only possible in very limited cases, such as proven equivalence or established technologies, always with valid scientific justification.
The clinical evaluation is documented in two key documents: the Clinical Evaluation Plan (CEP) and the Clinical Evaluation Report (CER).
The CEP forms the strategic basis of the clinical evaluation. It defines in advance how clinical evidence will be provided and includes, among other things:
The CER documents and evaluates all available clinical data and includes:
The CER is a necessary requirement for CE marking and must be regularly updated, particularly in the context of Post-Market Surveillance and Post-Market Clinical Follow-Up.
Manufacturers can use clinical data from comparable products if proven similarity exists:
The MDR places high demands on scientific justification and access to comparative data. The MDCG 2020-5 guideline specifies these requirements.
Clinical evaluation is a continuous process. After placing the device on the market, the manufacturer must continue to monitor its clinical performance.
The Post-Market Clinical Follow-Up serves to:
The PMCF plan and PMCF report are an integral part of the technical documentation.
WQS has been supporting medical device manufacturers for over 30 years with:
We draw on an interdisciplinary network of clinical and regulatory experts to clinically test your Class I, IIa, IIb, and III medical devices.
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Yes. According to the Medical Device Regulation (EU) 2017/745, a clinical evaluation is required for every medical device, regardless of its risk class (Class I, IIa, IIb, or III). It must be planned, documented, and regularly updated throughout the entire product life cycle.
Clinical evaluations must be performed by professionally qualified individuals. These individuals must have in-depth knowledge of medical technology, clinical applications, scientific methodology and the MDR. For higher-class or implantable medical devices, additional clinical expertise in the respective field of application is required. Manufacturers often work with specialised external consultants for this purpose. Contact WQSfor a tailored, non-binding quote.
The clinical evaluation must be updated continuously throughout the product’s life cycle. Even after the product has been placed on the market, the manufacturer must regularly monitor and update its clinical performance.
A clinical evaluation without a separate clinical investigation is possible if sufficient clinical data is available to demonstrate safety and performance for the intended purpose. This may be the case, for example, with established technologies, existing products, or the permissible use of equivalence data, provided that the MDR requirements are fully met.
Clinical evaluation is regulated in particular in Article 10 MDR (Obligations of the manufacturer), Article 61 MDR (Clinical evaluation), and Annex XIV MDR. In addition, guidelines such as MEDDEV 2.7/1 Rev. 4 and various MDCG documents apply to the interpretation of the requirements.
The clinical evaluation requires, among other things, information on the intended purpose, technical documentation, risk management results, clinical data from literature and studies, and market surveillance data. The exact scope is determined by the Clinical Evaluation Plan and the individual product profile.
Support for US companies to enter the European market. EU Rep, Certification, QM System, Technical Documentation, support of the Procedure, selection of a Notified Body, support of the Certification Procedure, preparation of a Clinical Evaluation, support of Clinical Studies, including the Logistical Concepts.
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