Legal Department, Universitätsmedizin Göttingen, Germany
*Corresponding author. E-mail address: raees.ahmed@med.uni-goettingen.de (R. Ahmed)
Online Published on 02 February, 2026.
The objective of clinical trials for medical devices is primarily the investigation and evaluation of their performance and safety. Of particular importance in this context is the contractual design of clinical trials for medical devices in the relationship between the sponsor and the trial center. The legal basis for this is the German Medical Device Implementation Act (Medizinprodukterecht-Durchführungsgesetz (MPDG)), which came into force on May 26, 2020, and is intended to concretize the EU regulations on medical device law at national level. Due to the principal of private autonomy, there are various options to draw contracts for the implementation of clinical trials for medical devices. However, certain points should be considered when drafting the contract and should become part of the contract. These include a heading and a preamble - they serve to clarify the contract and introduce its contents. Other important parts of the contract are the subject matter, contractual obligations, subject recruitment, audit and inspection, monitoring, provisions for premature test termination, test components, remuneration, contract duration and termination options, confidentiality, partial invalidity, and applicable law. They define the complex legal relationship between the clinic, the investigator and the sponsor, as parties to the contract.
A specific data base was used for law www.beck-online.de and digital journal archives (https://ezb.ur.de; www.digizeitschriften.de) at Universitätsmedizin Göttingen. All assumptions are based on the authors own day-to-day experience as a lawyer or legal advisor at legal department of Universitätsmedizin Göttingen.
For the legal certainty of all parties, the contractual components should definitely become part of the content of contracts for the performance of clinical trials for medical devices. It should be noted, however, that individual cases and their contractual requirements should be considered.
Contract, Clinical Trial, Medical Device, German Medical Devices Act (MPDG)
