What different types 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 trials are a step towards ensuring the safety and performance of medical devices.

There are various forms of clinical trials, e.g:

1. clinical performance investigations: Investigate whether the medical device fulfills its intended function.

2. clinical safety testing: Focus on the safety of the medical device for patients and users.

3. comparative tests: Comparing the medical device with existing products on the market.

4. multi-center investigations: Are conducted at different sites to collect broader data.

5. post-market clinical follow-up (PMCF): A post-market surveillance to assess long-term safety and performance.

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In the course of a medical device's development cycle, various clinical investigations may become necessary.