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If there is insufficient clinical evidence to prove the required clinical safety and performance of a medical device, clinical trials must be carried out. In principle, this applies to novel products, implantable medical devices and class III products. A clinical test must also be carried out without exception
- new indication
- new anatomical region of the body
- Changes to a marketed product that may have a significant impact on safety or effectiveness
- significant extension of the application time
- insufficient literature on efficacy and risks
Clinical studies with medical devices must be planned and carried out in accordance with EN ISO 14155 and other regulations. Additional regulations to be complied with can be found in the Ordinance on Clinical Trials of Medical Devices (MPKPV) and in the Medical Device Safety Plan Ordinance (MPSV). According to § 20 paragraph 1 MPG, the implementation requires approval from the BfArM/PEI and the approval of the responsible public ethics committee.
topic overview
- Legal and ethical foundations
- Study Design | controls
- Ethics Committee/Federal Authority
- Execution | Costs
- Strategic decision: clinical trial, yes or no?
target group
Management, strategic decision-makers, development management, regulatory affairs.
previous knowledge
Corporate strategy, product development, product certification.
KONTAKT:
Online
