Implementation of clinical evaluations of medical devices

If a manufacturer wishes to launch a new medical device on the market, demanding legal requirements must be met. In the following, the most important information regarding the clinical evaluation of medical devices is summarized for you.

What is a clinical evaluation?

Before a medical device is marketed, manufacturers must demonstrate its performance, safety and clinical utility.

A clinical evaluation (Article 61 and Annex XIV, see p. 164 MDR) is carried out for this purpose. The clinical evaluation can be based on objective data from the specialist literature or results from previous clinical studies. These must be analyzed and evaluated. The clinical evaluation is part of the technical documentation as part of the conformity assessment procedure for obtaining the CE mark and must be updated regularly after market launch. The clinical evaluation is therefore part of the quality management system and closely linked to risk management.

Legal basis

The content of a clinical evaluation is regulated by laws and standards. The previous directive on medical devices, the Medical Device Directive (MDD), was replaced on May 26, 2021 by the new EU Medical Device Regulation (MDR), also known as the European Medical Device Regulation. This brings with it significantly more demanding requirements. At the same time, the Medical Devices Act (MPG) was replaced by the Medical Devices Implementation Act (MPDG).

What is the clinical performance?

Clinical performance means the ability of a device, based on its technical or functional - including diagnostic - characteristics, resulting from any direct or indirect medical effect, to fulfill its intended purpose as stated by the manufacturer, so that, when used as intended by the manufacturer, a clinical benefit for patients is achieved.

What is the clinical benefit?

Clinical benefit is a positive impact of a device on a person's health as indicated by meaningful, measurable and patient-relevant clinical outcomes, including diagnostic results, or a positive impact on patient management or public health.

How should you proceed?

Phase 1: Planning

- Description of the objective and structure of the clinical evaluation

- Classification of the product: Is it a known or new technology/application?

- Determination of the intended use

- Create a target product profile if necessary

We will gladly accompany you from the very beginning and help you to complete the scientific evidence for your medical device on time.

Phase 2: Identification of suitable data sources

- Scientific literature

- Available clinical data, if necessary comparison with other products

- Clinical experience

- If not derivable from this: generation of new or additional clinical data on the basis of a clinical trial (for requirements see Annex XV, p. 167 MDR) in accordance with the clinical development plan (Clinical Evaluation Plan, CEP; see Annex XIV)

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Phase 3: Analysis and evaluation of the data

- Evaluation based on pre-defined criteria

- Evaluation of individual data sources: qualitative and quantitative analysis

- Systematic evaluation of the scientific literature

- Overall evaluation of the relevant data to assess whether there is evidence of the performance and safety of the medical device

- Comparison with other products

Phase 4: Reporting (Clinical Evaluation Report)

Phase 5: Post-market clinical surveillance (see Annex XIV, Part B)

- Periodic Safety Update Report (PSUR; see Article 86).

- Trend reporting (see Article 88 MDR)

- Results of market monitoring incl. corrective measures

- Total sales volume and estimate of the number of applications

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