Clinical data

Clinical data for clinical evaluation

For clinical evaluation, new, relevant clinical data must be continuously collected. This can include, for example, the following sources:
Clinical data for clinical evaluation

Figure: Clinical data and evaluation according to Regulation (EU) 2017/745

1. Scientific literature

The systematic conduct of a scientific literature search is a carefully planned process that includes not only extracting data from appropriate sources and determining their relevance for clinical evaluation, but also a critical assessment of methodological quality. Appropriate weighting of the literature is also necessary to ensure a reliable evidence base.

Product-specific scientific literature searches in medical journals (e.g., via PubMed, Embase, and other databases), textbooks, and product registries can identify clinical data. This data can relate to the product under consideration or to products proven to be similar/equivalent.

2. Clinical trials

The need for a clinical trial is usually determined during the clinical evaluation. If deficiencies in clinical data are discovered during this process, i.e., these data are insufficient or of insufficient quality, they must be collected as part of clinical trials.

The selection of the type of clinical trial depends primarily on whether the medical device bears a CE mark, is used within its intended purpose, and whether additional invasive or stressful procedures are to be performed on the trial subject. In the course of demonstrating conformity or further evaluating a device, there are essentially two types of clinical trials to which the requirements of Regulation (EU) 2017/745 (MDR) apply:

  • Clinical trials pursuant to Art. 62
  • PMCF studies pursuant to Art. 74

The figure shows the regulatory decision-making process for corresponding clinical trials. Whether a clinical trial requires approval or notification depends on the type of clinical trial. However, every clinical trial must comply with at least the applicable parts of EN ISO 14155 and the GDPR (General Data Protection Regulation) and, in most cases, involve an ethics committee.

Clinical trials
Figure: Regulatory decision path for clinical trials for proof of conformity or further assessment

3. Post-market data via PMS

As soon as an authorized medical device is made available on the Union market and used in practice, clinical data can be collected from post-market surveillance (PMS) or, if applicable, from post-market clinical follow-up (PMCF). Conducting PMS is mandatory; whether a PMCF is necessary is determined by the clinical evaluation. Activities within the scope of the PMS may include, for example, handling complaints, vigilance activities, interviewing patients or users, evaluating any feedback, and researching databases of supervisory authorities on incidents and safety corrective actions in the field of similar products on the market. They also include product-specific measures within the scope of the PMCF, including PMCF studies (see above). The collection of “real-world data” (= data from everyday clinical practice) always follows an active, continuous, and, above all, planned, methodical approach. The evaluation of such clinical data makes it possible, among other things, to identify and resolve underestimated complications and problems that were not recognized before market launch, as well as unforeseen use of a product throughout its entire product life cycle.

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