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How is a clinical assessment based on performance data created?

At medXteam, the focus is on clinical data. In this context, as CRO, we not only carry out clinical trials with medical devices in accordance with MDR and ISO 14155, but also offer all other options and forms of data collection and product approval as well as market surveillance. The focus is always on clinical evaluation, both during product approval and during clinical follow-up. One possible route for creating the clinical evaluation is based on so-called performance data. How can such a clinical assessment be carried out? What options are there to provide clinical evidence? And what role do clinical data play in this? In this blog post, we explore these questions, particularly explaining when and how this route of clinical assessment can be used .

Abbreviations

MDR Medical Device Regulation; EU Regulation 2017/745

PMCF Post-Market Clinical Follow-up, clinical follow-up

CEP Clinical Evaluation Plan

CDP Clinical Development Plan

Underlying regulations

EU Regulation 2017/745 (MDR)

1 Introduction

As already described in the last blog post, the clinical evaluation for all medical devices - from Class I to Class III - is an essential step for every manufacturer of medical devices. This is derived from Article 61 of EU Regulation 2017/745 (MDR):

“The manufacturer shall determine and justify the scope of clinical evidence to demonstrate compliance with the relevant general safety and performance requirements. The level of clinical evidence must be appropriate to the characteristics of the device and its intended purpose. To this end, manufacturers shall carry out, plan and document a clinical assessment in accordance with this Article and Part A of Annex XIV."

If the “performance data” route was defined during planning in the CEP, all requirements for the process and for the creation of the clinical assessment that result from the MDR and also from MEDDEV 2.7/1 Rev. 4 must still be adhered to . How this works: This blog post provides the relevant answers .

2. The route via performance data

The way to demonstrate the clinical performance of a product through performance data has always been possible and remains so under the MDR (Article 61):

„If demonstration of compliance with essential safety and performance requirements based on clinical data is considered inappropriate, any such exception shall be based on the manufacturer's risk management and taking into account the specific characteristics of the interaction between the device and the human body, the intended clinical performance and the information provided by the manufacturer; this applies without prejudice to paragraph 4. In this case, the manufacturer shall duly justify in the technical documentation set out in Annex II why he demonstrates compliance with essential safety and performance requirements solely on the basis of the results of non-clinical testing methods, including performance evaluation, technical testing ( “bench testing”) and preclinical evaluation, is considered suitable .“

The decision is based on various aspects:

  • the result of risk management
  • the characteristics of the interaction between product and body
  • proof of performance based on product evaluations (technical, in-vitro)
  • the result of the preclinical assessment (initial literature search, verification tests, etc.)

This decision must be appropriately explained and documented in the clinical evaluation plan.

This route is preferred when a clinical trial offers little benefit. A typical example of this is the wooden tongue depressor, for which clinical data does not exist in the literature. In such cases, technical data such as breaking strength and workmanship indicate the safety and performance of the product.

As the equivalence route becomes less and less possible and applicable, it is becoming more and more the new standard based on performance data if there is no need to generate your own clinical data.

Below are examples of when this route makes sense:

2.1 Example – Medical Software

Most software products (Class I and IIa) are examples of products where performance data makes sense. The reasoning for this decision is as follows:

The product has been fully verified as part of the software life cycle process in accordance with IEC 62304 and all tests have been successfully completed. The testing included unit testing, integration testing, system testing and usability testing. Based on these tests, it can be shown that the product works effectively.

According to MDCG-2020-1 (Guidance on Clinical Evaluation (MDR)/Performance Evaluation (IVDR) of Medical Device Software), scientific validity is defined as the extent to which the output of the software product is valid based on the selected inputs and algorithms is associated with the desired physiological state or clinical disease. In order to provide proof of scientific validity, a literature search is carried out, which also includes proof of benefit according to the MDR as well as determining the state-of-the-art and identifying the safety and performance of the medical device.

The clinically relevant components of the system are the implementations of the algorithms/questionnaires for diagnosis or the course of therapy. The literature search focuses on scores/detection algorithms as well as on the general use of digital products in the diagnosis/therapy of the indicated indications.

Table 1: Clinical evaluation of a software product

2.2 Example – dentist chair

Another product whose clinical performance, safety and benefits can be easily assessed using performance data and for which a clinical test makes no sense is the dental treatment unit: the dental chair.

Such products are active medical devices that are used to treat children and adults in the dental field. These products are dental treatment devices according to ISO 7494 with a dental patient chair according to ISO 6875. They are intended exclusively for use in dentistry and may only be operated by medical professionals. The dental treatment unit is used as an aid for patient positioning and for treatment in the dental field. Depending on whether dental instruments are part of this treatment unit and, if so, which ones, these products are classified in class IIa or IIb.

Due to the clear intended purpose of these products, the question of whether a clinical trial should be carried out on humans is unnecessary. The claims about the product relate to the ergonomics for both the patient and the practitioner and user of the product. It also emphasizes efficiency and ease of operation, and prescribed procedures and supporting components to facilitate infection control and maintain water quality. These statements are not suitable endpoints for a clinical trial. However, they can be supported with performance data. For example, the topic of ergonomics and ease of use can be proven via the usability test (DIN EN 62366-1). Compliance with the relevant standards and regulations on water hygiene and quality also confirms these claims about the product. The reason for choosing the path based on performance data is now listed here in Table 2: