Clinical examination of medical devices
If sufficient clinical evidence is not available to demonstrate the required clinical safety and performance of a product, clinical trials must be performed. Novel products, implantable medical devices and Class III devices must always undergo a clinical trial. In individual cases, of course, this can be waived, and indeed if existing clinical data sufficient. A clinical trial is to be performed without exception
New anatomical region of the body
Modifications to a product placed on the market possibly having a significant impact on safety or efficacy
Significant extension of application time
Insufficient literature on effectiveness and risks
Clinical trials of medical devices must be planned and performed in accordance with EN ISO 14155 "Clinical review of medical devices to humans - good clinical practice" and other requirements. The requirements of EN ISO 14155 are comparable to the ICH-GCP for clinical trials with medicinal products. Further regulations to be observed can be found in the Ordinance on Clinical Trials of Medical Devices (MPKPV) and in the Medical Devices Safety Plan Ordinance (MPSV).
The implementation of clinical trials of medical devices and IVD requires, according to § 20 Abs. 1 MPG, approval by the responsible BoB BfArM / PEI and the approval by the competent public-law EC eg at medical associations or university hospitals.
We have decades of extensive experience in clinical MPG testing up to class III / active implants. The fulfillment of clinical trial requirements for medical devices can be supported by Prof. Zenner and Partners through the creation of an Investigator's Brochure as well as by providing patient education and consent information. In addition, advice on the preparation of the test plan in accordance with DIN EN ISO 14155 and the clinical evaluation of the results can be provided.
Also, the clinical evaluation center Prof. Zenner can support the electronic DIMDI application and contribute to the completeness of the application documents.
Application for approval of a clinical trial
Applications for the approval of clinical trials of medical devices and IVD according to § 20 Abs. 1 MPG by the competent BoB BfArM / PEI and the approval by the competent public-law EC, eg at medical associations or university hospitals, must be submitted via DIMDI.