Annex XV of the MDR

Annex XV of the Medical Device Regulation (MDR) deals with the requirements for clinical investigations of medical devices.

Regulation (EU) 2017/745 (MDR) refers to ISO14155:2020, which regulates the basic requirements for clinical investigations. In Germany, the MDR regulations on clinical investigations of medical devices are supplemented by national (German) requirements.

The most important contents of Annex XV of the MDR relating to clinical investigations are listed here:

1. General requirements:
   • Ethical principles according to the Declaration of Helsinki
   • Scientific validity and reliability of the data
   • Protection of the rights, safety and welfare of subjects
2. Documentation requirements:
   • Detailed test plan
   • Examiner information
   • Informed consent form
   • Ethical evaluation
3. Protection of vulnerable groups:
   • Special precautions for minors, pregnant women and persons unable to give informed consent
4. Conduct of the clinical investigation:
   • Qualification of the investigator
   • Suitability of the test centre
   • Medical care of the subjects
5. Reporting obligations
   • :Reporting of serious adverse eventsDocumentation
   • and reporting of incidents
6. Insurance and liability:
   • Adequate insurance or liability provision for subjects
7. Informed consent requirements
   • :Comprehensive and understandable information for trial subjectsFreedom
   • of participation
8. Documentation and storage
   • :Complete and accurate recordsLong-term
   • storage of documents

These requirements are designed to ensure that clinical investigations of medical devices are conducted in an ethical, scientifically sound and safe manner to ensure the safety and performance of medical devices.

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