Medical devices act

According to § 1, the purpose of the Medical Devices Act, also known as the MPG, is1 to "regulate the marketing of medical devices and thereby ensure the safety, suitability and performance of medical devices as well as the health and necessary protection of patients, users and third parties. In Germany and Austria, the Medical Devices Act comprises the implementation of the European Directives 90/385/EEC for active implantable medical devices, 93/42/EEC for medical devices and 98/79/EC for in vitro diagnostic medical devices. The Medical Devices Act does not regulate the handling of medicinal products.

In clinical studies, the MPG thus ensures compliance with safety measures and ensures the protection of patients / test persons in clinical studies. The Medical Devices Act regulates the responsibilities for testing medical devices in clinical studies. The procedure at the ethics committee (§ 22) and the approval procedure at the higher federal authority (§ 22a) are also specified. Before the start of a clinical trial or performance evaluation, the MPG requires that these trials be approved or evaluated by the responsible higher federal authorities and the ethics committee. Applications can be submitted online via the portal of DIMDI (German Institute for Medical Documentation and Information).

The Medical Devices Act was drafted in August 1994 and revised in August 2002. In the currently valid version of the Medical Devices Act of 21.07.2014, the MPG consists of nine sections containing 44 paragraphs:

• First section: purpose, scope of application of the law, definitions
• Section Two: Requirements for medical devices and their operation
• Section Three: Notified Bodies and Certificates
• Section Four: Clinical evaluation, performance evaluation, clinical trial, performance evaluation audit
• Section Five: Monitoring and protection against risks
• Section Sechter Abschnitt: Competent authorities, regulations, other provisions
• Section Seven: Special Provisions for the Bundeswehr
• Section Eight: Penalty and Fines Regulations
• Section nine: Transitional provisions

Section 23b of the MPG, which specifies exceptions to clinical trials, is particularly important for non-interventional studies:

"Sections 20 to 23a do not apply if a clinical trial is conducted with medical devices which, according to Sections 6 and 10, may bear the CE marking, unless the purpose of the medical device is different or additional invasive or other stressful examinations are carried out.

A stressful examination is e.g. a blood sample, a computer tomography or any other additional examination that is carried out for study purposes. Simple questionnaires, on the other hand, are not usually interpreted as stressful examinations.