A Clinical Evaluation Report (CER) is required for all medical devices irrespective of their classification.
You might be aware that new clinical evaluation guidelines (MEDDEV 2.7.1 Rev 4) have now been published by the European Commission that signify how to analyse medical device safety and performance.
For companies to maintain the CE mark for existing products and to secure CE marking for new products, it is essential to demonstrate through the CER that the benefits of using the device outweigh any risks.
Medilink’s innovation and commercialisation team have been authoring CER’s since 2010 (when CER’s first came into force) and are amongst the most experienced specialists in this field.
For a confidential, no obligation discussion on how we can help you with your clinical evaluation please contact Patrick Trotter (firstname.lastname@example.org).