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 ISO 15189 specifically focuses on the unique requirements of medical laboratories and the significance should not be underestimated, especially in the field of public health.  ISO 15189 was fundamentally revised at the end of 2022. It sets out more detailed requirements and emphasizes the importance of risk management even more strongly. Furthermore  Vitro Diagnostic Medical Devices regulation (IVDR) now makes concrete demands on laboratories.  A lot of medical laboratories are not fully aware of the existing and the new requirements. Lets review some of the main points:

In-house IVD: What are they? An IVD is  “a laboratory developed test (LDT)  that is designed, manufactured and used within a single laboratory or  within health institutions established in the Union”.   This includes any device used to examine or monitor humans, including “software or systems” connected to in vitro activity. 

 A medical laboratory can also create CE Marked devices to an LDT by:   

• combining  products or processes that are not intended for the combination, or
• uses a CE-IVD device outside its intended purpose, e.g., when they:
  • misuse the device (off-label use) or
  • modify commercial devices (including if they deviate from the instructions for use of conventional IVD devices).

What are Legal requirements for IVDR?

Laboratories must develop, manufacture and surveil their own Laboratory Developed Tests (largely) in conformity with the requirements of the IVDR depending on a product’s risk classification.  There are four categories (A to D) with A representing the lowest risk and D the highest. 

The use of commercially available IVD devices is preferred and laboratories can only offer their own LDTs if the devices on the market do not meet the required performance.

Your next steps as a medical laboratory?

•  You first need to identify and  determine your product/assay's risk classification.
• Comply with the additional requirements of Article 5 (5) of the IVDR. This in main requires a clinical validation. 
• Expand your quality management system to include regulations of laboratory developed tests.