Clinical data

Clinical Data for Clinical Evaluation

Relevant clinical data must be continuously collected for the purpose of clinical evaluation. The following sources, among others, may be included:
Clinical data for clinical evaluation

1. Scientific Literature

The systematic conduct of a scientific literature search is a carefully planned process. It not only involves extracting data from appropriate sources and assessing their relevance to the clinical evaluation, but also includes a critical appraisal of the methodological quality of the literature. An appropriate weighting of the evidence is essential to ensure a reliable evidence base.

Product-specific scientific literature searches in medical journals (e.g., via PubMed, Embase, and other databases), specialist books, and product registries can be used to identify clinical data. These data may relate to the device under evaluation or to devices that have been demonstrated to be equivalent.

2. Clinical Investigations

The need for a clinical investigation is typically identified during the clinical evaluation. If gaps in clinical data are revealed ‒ i.e., if data are insufficient in quantity or quality ‒ they must be generated through clinical investigations.

The type of clinical investigation required depends largely on whether the medical device is CE-marked, whether it is used within its intended purpose, and whether any additional invasive or burdensome procedures will be applied to participants.

In the context of conformity assessment or further product evaluation, two main types of clinical investigations are defined under Regulation (EU) 2017/745 (MDR):

  • Clinical investigations acc. to Article 62
  • PMCF studies acc. to Article 74

The regulatory decision pathway for determining the appropriate type of clinical investigation is illustrated in the corresponding figure. Whether a clinical investigation requires prior authorisation or notification depends on the type of clinical investigation. However, every clinical investigation must at a minimum comply with the applicable sections of EN ISO 14155 and the General Data Protection Regulation (GDPR), and in most cases, approval from an ethics committee is also required.

Clinical trials

3. Post-Market Data via PMS

Once an approved 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). While PMS is mandatory for all devices, the necessity of PMCF must be determined as part of the clinical evaluation. PMS activities may include, for example, handling complaints, vigilance activities, surveys involving patients or users, evaluation of feedback, and researching databases of competent authorities on incidents and safety corrective actions in the field of similar products on the market. They also include product-specific measures within the framework 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 methodological approach. The evaluation of such clinical data enables, among other things, the identification and elimination of underestimated complications and problems that were not recognised prior to market launch, as well as unforeseen use of a product during the entire product life cycle.

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