CleanControlling: GLP-compliant or non-GLP-compliant?

Differences between GLP-compliant and non-GLP-compliant testing of medical devices under the MDR

The decision as to whether the test should be GLP-compliant or non-GLP-compliant depends to a large extent on the market in which the products are to be approved.

GLP-compliant testing

Good Laboratory Practice (GLP) is a quality system that governs the organizational processes and conditions under which non-clinical health and environmental studies are planned, conducted, monitored, recorded, archived and reported. Conducting GLP-compliant testing is recommended when seeking approval of medical devices in the U.S. market (or in markets aligned with the U.S. FDA). The U.S. Food and Drug Administration (FDA) favors GLP-compliant testing because it ensures strict quality standards.

The following benefits are associated with GLP-compliant testing:

FDA acceptance is higher for trials conducted in compliance with GLP.
Strict quality controls: Additional quality controls and more extensive trial documentation are part of the GLP concept.
In addition, the approval strategies are more flexible if subsequent FDA approvals are sought

Non GLP-compliant tests

For the European market, especially if CE approval is being sought, non-GLP-compliant tests may be sufficient

Advantages of non-GLP-compliant testing:

Cost-effective: non-GLP compliant testing is often less costly as it has less stringent requirements to fulfill.
Sufficient for CE approval: Non-GLP-compliant tests are often sufficient for CE marking.

GLP certificate409 KB

You have questions?

Send us a message via our contact form and we will get back to you as soon as possible!

Go to contact form

Conclusion

The decision as to whether GLP-compliant or non-GLP-compliant tests are carried out depends largely on the target market.

For the US market (and other US FDA orientated markets) GLP compliant testing is almost essential to facilitate FDA approval.
For the European market and CE approval, non-GLP compliant testing may be sufficient.

Companies should therefore carefully consider which approval strategies to pursue. Performing GLP-compliant testing therefore ensures maximum flexibility in the approval strategy and represents the state of the art.