What different forms of clinical investigations of medical devices are there?

The European Medical Device Regulation (EU) 2017/745 (MDR), for in-vitro diagnostics (EU) 2017/746 (In-vitro Diagnostics Regulation, IVDR) and in Germany the Medical Device Law Implementation Act (MPDG) are legal frameworks that set standards for medical devices.

Clinical investigations are a step towards ensuring the safety and performance of medical devices.

Clinical investigations of medical devices can be divided into different categories according to the MDR and, in Germany, the MPDG:

1. clinical investigations for conformity assessment purposes

These tests serve the following purposes in accordance with Article 62 MDR:

• Verification of the suitability of the device for the intended purpose
• Evaluation of the clinical benefit
• Investigation of clinical safety and possible side effects

These trials are subject to authorisation and must meet the requirements of Articles 62 to 81 and Annex XV of the MDR.

2. post-marketing clinical investigations (PMCF studies)

These studies are conducted in accordance with Article 74 MDR in order to:

• further evaluate CE-marked devices within the scope of their intended purpose
• collect long-term safety and performance data

PMCF studies are subject to less stringent requirements than conformity assessment studies.

3. other clinical investigations

According to Article 82 MDR, this includes all clinical investigations that do not serve the purposes listed in Article 62, such as

• basic research
• Feasibility studies

These studies must fulfil certain requirements of the MDR, but are subject to less strict regulations than clinical investigations according to Art. 62 to Art. 81 of the MDR.

4. performance studies for in vitro diagnostic medical devices

These are carried out in accordance with the In Vitro Diagnostic Medical Devices Regulation (2017/746, IVDR) and are used to evaluate diagnostic medical devices.

Different clinical investigations may be necessary during the development cycle of a medical device. Each form of clinical investigation is subject to specific regulatory requirements and authorisation procedures. The choice of the appropriate form of trial depends on the stage of development of the product, its risk potential and the purpose of the trial.

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