Numerous medical devices have been on the market for many years or even decades. But do they automatically count as «well-established technologies»? And what does this mean for the clinical evaluation and the clinical evidence required by the MDR? Dr. rer. nat. Marion Fehlker from novineon CRO describes what MDR and MDCGs mean by “well-established technologies” and what clinical requirements apply to this product group.
The instructions for use is where the manufacturer and the user connect. Therefore, this document is of particular importance. The MDR did not only clarify the requirements for use but also made them stricter. The following article describes in detail when the instructions for use should be revised. In addition, the most important interfaces between instructions for use, clinical evaluation and risk analysis are discussed.