Conformity assessments of medical devices
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.
Our experts assist you with clinical evaluations
SCC conducts scientific literature searches in line with the latest MEDDEV guidance 2.7/1 revision 4, Annex A4 and A5, which forms the basis for preparing and updating clinical evaluations. In terms of clinical evaluations, we offer specific services designed to meet the individual needs of our customers by either providing support during the evaluation process or preparing a clinical evaluation report or its update.
- Equipped with recent and individually customized literature, you can get an idea of your device’s ranking on the global market and the key factors relevant for the medical practice.
- Our up-to-date clinical evaluation helps you to save time and speed up the conformity assessment procedure with your notified body.
- With literature evidence prepared by our experts, you can save costs by avoiding unnecessary clinical investigations or PMCF studies.
Our expert service
Feel free to contact us for more information on the procedure of a clinical evaluation or request a call from our expert.