Clinical Evaluation

Clinical Data Requirements and Evaluation

Stricter clinical data requirements are now required under the MDD and will continue under the MDR

• CERs are very labor intensive requiring specialized clinical/regulatory experience
• There is increased scrutiny on clinical data
• CERs are required for all devices regardless of risk class and must be updated at least annually
• Planning, collection and analysis of clinical data, and the development of compliant CERs should happen now

CER Process

• CER Procedures - Create compliant procedures related to: the development of CERs, conducting literature reviews, and data appraisal methodology
• CER Strategic Planning - MCRA can perform an analysis of available data to determine what is required to meet the regulatory level of sufficiency; this includes an assessment of pre-market investigation data and/or equivalent comparator data
• CER Drafting - MCRA can develop the entire CER or specific sections per the established Rev 4 guidance including equivalence justifications, clinical investigation summary, literature review (see below), post-market data assessment and summary, and benefit-risk assessment 
• Comprehensive Literature Review - MCRA can perform comprehensive literature reviews including database searches and safety and performance analyses
• Evaluation of Clinical Evidence - As part of the CER process, MCRA will assess all data sources to generate a benefit risk assessment to determine the benefit risk profile of the device; whether any actions are required on the part of your company, and ultimately, support the marketing application of the device 

Our Experienced Team

• Years of experience, developing new CERs and updating existing ones
• Team of trained writers with both technical writing and regulatory knowledge 
• Capability to conduct a literature review and analysis across multiple databases with multiple reviewers
• Integration of Clinical, Regulatory, & Quality experts who understand the content of a successful CE
• Capacity to act independently on all components with the exception of internal data required from the sponsor

Contact a Regulatory Affairs Expert