23 October 2023

Key Aspects of MDR and Patient Safety in the Procurement of Medical Devices

Key Aspects of MDR and Patient Safety in the Procurement of Medical Devices

For several years, the European regulatory framework, MDR (Medical Device Regulation), has been closely followed in the field of medical technology. MDR's overarching goal is to ensure patient safety by establishing strict requirements for transparency, documentation, traceability, and feedback related to medical devices.

How does MDR relate to the procurement of medical devices?

Within MDR, there are several harmonized standards that every manufacturer must adhere to when CE marking their products in accordance with MDR. These standards include requirements for biological evaluation, quality management systems, risk management, labeling, and electrical safety.

What MDR clearly emphasizes is the requirement for clinical evidence. This means that every manufacturer must substantiate their clinical claims with supporting documents and facts. Making claims about the properties of a medical device is strictly prohibited under MDR. For example, if a medical device can be used as a pain relief aid, clinical evidence is required to demonstrate that this specific product is intended for this use and that there is evidence of its intended use being fulfilled.

Clinical Evidence in Procurement

When assessing medical devices, it is critical for procuring authorities to understand the difference between various types of evidence that support the manufacturer's claims about their products. A clinical claim for a medical device is typically established through clinical data, which means data collected while the product is used in its intended user environment and with its intended users.

Levels of Evidence

Different types of evidence are usually categorized based on the level of research quality or study type. The category at the top of the hierarchy is systematic meta-analyses, often required for products in higher-risk classes. The next level includes randomized studies, followed by cohort studies and case studies. At the bottom of the hierarchy are laboratory studies and animal tests conducted in controlled laboratory environments. (1)

In conclusion, for procuring authorities to work in line with MDR while ensuring patient safety, it is of utmost importance that they demand clinical evidence for the medical devices they are considering for procurement. Understanding and distinguishing between clinical evidence and supporting data will be crucial to ensure that healthcare products meet the high standards of patient safety and quality prescribed by MDR.

(1) Openmd. (2021) Levels of Evidence. Retrieved October 23, 2023.