Every medical device sold into Europe, irrespective of its classification, must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File. Since our last update on CER execution a renewed guidance in the form of MEDDEV 2.7/1 Rev. 4 was released in June 2016.
This paper aims to highlight common sources of non-compliance; clarify requirements and address gaps in clinical evaluation guidance; and help manufacturers attain compliance and prepare for future regulatory changes. Moreover by taking a pro-active approach to clinical evaluation reporting, medical device companies can achieve improvements and reap business benefits that will keep them ahead in their market.
Maetrics has longstanding experience applying new and complex standards consistently and efficiently while developing compliance strategies critical to your company’s success. Our third party support for MDR, IVDR, MDSAP, ISO 13485, and Supplier Quality Audits can deliver value and objectivity across the whole review and implementation process.
Founded in 1984, Maetrics is a global life sciences consulting firm focused exclusively on regulatory, quality and compliance solutions for Medical Device, Diagnostic, Pharmaceutical and Biotechnology companies.