What must be considered in terms of reporting and approval requirements and vigilance for PMCF studies?

In clinical trials of medical devices that are already on the market, i.e. approved as such, in accordance with European (MDR 2017/745), and even more specifically under the respective national laws, different reporting and approval requirements and vigilance must be observed.

In Germany, the Medical Device Law Implementation Act (MPDG) applies. These studies are called post-market clinical follow-up (PMCF studies). Vigilance is the management of adverse or serious adverse events that may occur during a clinical trial.

‍

There are special requirements for these studies, in accordance with the further legal subdivision. Depending on the purpose and goal of the clinical trial, different study designs are selected and this results in which regulations apply and which requirements and obligations must be met when approving clinical trials by authorities and the vigilance.

The breakdown of such clinical trials by market (PMCF) results from answering the following questions:

• Is this a study aimed at achieving a new purpose (another disease or another patient)?
• Is the product intended to answer a scientific question?
• Should study participants still undergo invasive (e.g. blood samples) or stressful tests or measures (e.g. not eating or drinking anything for a longer period of time) during the study?

‍

PMCF study without additional invasive or burdensome procedures in the context of MDR and MPDG:

These clinical studies are neither required to report nor require approval from the ethics committee or federal authorities. The obligation to provide advice under professional law for doctors (see Section 15 of the respective Professional Code for Physicians) by the Ethics Committee is a prerequisite for the start of such a clinical trial.

Serious adverse events (SAEs) do not have to be reported to federal authorities; the vigilance requirements remain valid indefinitely.

The procedure in Germany therefore complies with the previous regulation in the MPG for clinical investigations, which met the criteria under Section 23b MPG.

Other post-marketing clinical trials of a medical device that is used as part of its intended use and in which the test subjects are not exposed to any additional invasive or burdensome procedures are regulated in accordance with Article 82 of the MDR:

In Germany, Section 47 paragraph 3 of the MPDG suspends the requirements of paragraphs 1 and 2 of the same paragraph. This includes the need for approval from an ethics committee and the obligation to report to higher federal authorities.

The reporting requirements for incidents must be observed. The obligation to report serious adverse events (SAEs) is abolished by Section 64 paragraph 4 of the MPDG for these clinical trials. The obligations arising from professional law for doctors, such as professional advice when participating in research projects, remain unaffected.

Where appropriate, further provisions arising from other legal requirements must be taken into account when carrying out clinical trials.

‍

Post-market clinical trials of medical devices (PMCF studies) are subject to regulatory requirements in Germany in accordance with MDR and MPDG. Depending on the study design — particularly in the absence of additional invasive or burdensome procedures — reporting requirements to ethics committees or federal authorities are waived (Section 47 (3) MPDG). The obligation to provide advice under medical professional law remains mandatory, while reporting serious adverse events (SAEs) for certain studies is waived (Section 64 (4) MPDG). Vigilance regulations and compliance with other legal frameworks must always be observed.

If you are interested in post-market clinical trials (PMCF), please feel free to arrange a first, non-binding consultation with us. We're here for you!