Planning and preparing Clinical Evaluation Reports (CERs) is now one of the most important tasks that all medical device companies must resource. Such reports show that the benefit risk ratio is favourable and acceptable compared to alternative solutions. Furthermore, the CER critically analyses all data and documentary evidence to support indications and product claims. The CER also helps in the identification of clinical risks, and identification of gaps that should addressed in future post-market clinical follow-up (PMCF).
With new guidance documents coming out from the Medical Device Coordination Group on a regular basis, such as “clinical evidence for medical devices, previously CE marked under Directives 93/42/EEC or 90/385/EEC”(MDCG 2020-6), means that there are now options and it’s important to get the clinical evaluation strategy right the first time, which can save both effort and cost.
Medilink is being approached for help more frequently from companies that are struggling to complete CERs or who have had their CERs returned for not being compliant. If you need help with your CER strategy and planning, or have any questions on this topic, please get in touch at firstname.lastname@example.org