In the EU, the technical documentation and clinical evaluation form the central part of medical device conformity assessments in cases where clinical investigations are not required. With the introduction of the new MDR (EU) 2017/745, the rules for planning and updating clinical evaluations have been tightened.

SCC can search for and provide you with scientific literature in line with the latest MEDDEV guidance 2.7/1 revision 4, which forms the basis for preparing and updating clinical evaluations.

For clinical evaluations, SCC offers a broad range of services: We can support you during the process or – based on the data you provide – fully prepare or update the clinical evaluation for your medical devices.