IVD performance evaluation testing with "residual samples"?

Category: compliance, product safety, product liability Industry: healthcare Author: Year:
Miriam Schuh

Need for "residual samples"

Manufacturers of in vitro diagnostic ("IVD") devices rely on using sample material of human origin as part of product development and to perform performance evaluation testing. Corresponding material is generally available: so-called "residual samples" regularly accumulate in medical diagnostic laboratories. At present, however, this material is generally disposed of and not passed on to manufacturers for IVDs. The reason for this is the concern of the laboratories that the provision of such residual samples could violate the rules of the GDPR or medical device regulations.

The term "residual sample"

Uncertainty regarding the handling of residual samples exists simply due to the fact that the term is not mentioned in the regulations currently still applicable to IVDs, the IVD Directive (PDF) and the Medical Devices Directive (only in German). It was not until the IVD Regulation and the Medical Devices Implementation Act (MPDG) came into force that the term was defined and made an issue. In principle, there are possible uses for residual samples. This can be possible under different conditions in each specific case. In addition, notification obligations and patients' rights must be observed.

Recommendation for action

IVD manufacturers should consider the following prior to using sample material in the context of product development or performance evaluation:

1.    Does the material basically constitute usable "residual samples" in the terms of the regulations?
2.    Is patient consent required for use?
3.    Are the regulatory requirements for use met?

[September 2021]