Waiver of clinical data to demonstrate compliance to the essential requirements in initial clinical evaluation
August 25th, 2025
Waiver of clinical data according to Article 61(10) of the MDR
A waiver of clinical data in the clinical evaluation is possible if the nature of the product, sufficient non-clinical data and risk management allow this. Sufficient non-clinical data are available if all clinical functions of the product can be demonstrated through technical and pre-clinical tests
Using of a waiver as a work facilitation? Read this article and find out more at a knowledge lunch at qtec.
Clinical data in clinical evaluation
The MDR's requirement in article 61(1) generally applies to the demonstration of clinical performance including the benefit and safety of a medical device, through clinical data.
However, the waiver of clinical data constitutes an exception, which the MDR regulates in its own paragraph, article 61(10). It states that the evidence based on clinical data must be considered inappropriate. Documents of the MDCG series describe special use cases.
The evidence that clinical data is unsuitable can also be seen as positive evidence: it must be shown that all essential requirements can be demonstrated by evidence other than clinical data. Therefore, we will look at the cases in which the demonstration of benefit, performance and safety is possible entirely based on non-clinical data.
Possible applications can often be found in the field of accessories for medical devices, the specifications of which can be described technically. This applies, for example, to
- hoses
- anaesthetic vaporiser and
- some Class I products operated by hand, such as
- Scissors
- Scalpels
- Tweezers
All such products can be specified without using physiological, medical or pharmaceutical knowledge gathered from humans. They are based on mathematical, physical or chemical principles and methods.
Caution: Lack of necessary clinical data alone does not justify a waiver, but leads to a clinical investigation. This in turn must be useful, allow a clinical question and be ethically justified (Annex XV I.1 MDR). There must be a question that can only be answered by an investigation on humans. Otherwise, the risks of a clinical investigation would not be ethically justifiable.
What must be fulfilled to dispense from clinical data?
Article61 (10) identifies a number of characteristics that must be fulfilled in order to follow this path in clinical evaluation. This means that it is possible to demonstrate compliance of the product with the essential safety and performance requirements without clinical data. The following aspects are to be considered:
- No clinical investigations according to Article 61 (4) are mandatory
- The exception is justifiable based on risk management and documented there
- Special features of the interaction of the product and the human body are taken into account
- Special features of the intended clinical performance
- Information supplied by the manufacturer
- Results non-clinical testing methods
- Results of performance evaluation
- Results of the technical tests
- Results of the pre-clinical evaluation
- Documentation of the results in technical documentation
The abstract points above mentioned can be illustrated as follows.
No clinical investigations according to Article 61 (4) are mandatory
Clinical investigations must always be carried out for all implants and Class III products. Article 61(4) in connection with Article 61(6) MDR govern exceptions. Thus, a waiver of clinical data is ineligible for these products.
The exception is justifiable based on risk management and documented
Another aspect is that risk management considers the waiver of clinical data and raises no objections. Furthermore, the risk assessments must also do without clinical data and all risk mitigation measures must be technically specified and verifiable in the laboratory.
Special features of the interaction of the product and the human body are taken into account
In order to be able to do without clinical data, the interaction of the product with the body must be describable by technical, physical or chemical principles and/or effects. This waiver is generally not possible if pharmaceutical or physiological effects play a role or if the human being is part of a physiological control loop.
Examples of such technical effects are, for example, the mixture of a gas of several components (oxygen content of a breathing gas), the analysis of this mixture, its conditioning (temperature) or transfer (breathing hoses).
A physical effect should be the illumination of a body or a body area for diagnostic purposes.
An indication of physiological effects exists when the technical design of the product requires knowledge from the field of physiology. These include, for example, the required frequency, duration and intensity of irradiation with light for the treatment of diseases of the skin or the required intensity of shock waves in lithotripsy.
In the case of ventilators, the control to a certain oxygen saturation of the blood or the frequency of spontaneous breathing under assisted ventilation would be examples of an existing physiological control loop.
Special features of the intended clinical performance
The manufacturer determines the clinical performance of the product through the intended purpose. Whenever physiological effects are detected or clinical effects, i.e. changes in the patient’s health state are the subject of the intended purpose, it can be assumed that clinical data are needed.
If, on the other hand, the intended purpose is worded in such a way that no change in the state of health is advertised, a waiver may be considered. The more technical the intended purpose is, the more likely it is that clinical data can be dispensed from.
Delineation from the non-medical product
When wording the intended purpose, however, attention must be paid to whether the product is still fulfils the definition of a medical device in accordance with Article 2(1) MDR.
Information supplied by the manufacturer
The manufacturer’s information provided in the instructions for use, marketing materials and clinical evaluation must also be worded in such a way that they do not promise any services beyond the intended purpose.
Results of non-clinical testing methods
The non-clinical test methods include all tests that can be carried out in the laboratory, i.e. those available for the validated and verified test instruments. This includes mechanical patient simulators.
Results of performance evaluation
For the performance evaluation, a complete coverage of all functions that the product performs for the patient, i.e. in particular those which qualify the product as a medical device is crucial.
Results of the technical test
All laboratory tests are recorded here, which demonstrate compliance with the requirements of Annex I No. 10ff MDR.
Results of the pre-clinical evaluation
Annex VII 4.5.4 a) MDR mentions examples of methods belonging to pre-clinical evaluation: pre-clinical testing, for example laboratory testing, testing of simulated use, computer models, use of animal models.
Documentation of the results in the technical documentation
All results of the above mentioned non-clinical test methods shall be compared, inter alia, to the benefits and clinical performance of the product in the clinical evaluation plan set out in Annex XIV No.1 (a) MDR. If it can be shown that all clinical performance and aspects of clinical safety can be fully demonstrated by technical examination or pre-clinical evaluation, both the requirement of the demonstration by clinical data and secondary of a clinical investigation are eliminated.
Conclusion
The manufacturer should see the obligation to plan the clinical evaluation as a possibility to minimise the proportion of functions that must be demonstrated via clinical data in the clinical evaluation. If this succeeds completely for all functions and also the other requirements of Article 61 (10) are fulfilled, the waiver of clinical data is well justified.
Outlook and further literature
The manufacturer may facilitate the identification of those clinical functions that are eligible as candidates for evidence of clinical data. During the development process, all decisions in the design of the product must be documented that are based on physiological or clinical knowledge. This can be easier than reconstructing these decisions from the finished product.
For clinical evaluation, there are further posts from qtec with an overview of the process (Clinical evaluation of medical devices under the MDR) and for the specific case of software as a medical device (Clinical evaluation of software as a medical device according to MDCG 2020-1)
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