MEDDEV 2.7.1, Revision 4 for Clinical Evaluation and the Latest 2016 Guideline: A Guide for Manufacturers and Notified Bodies

Key Topics

• This revised MEDDEV is generated within a context of increased scrutiny on the Notified Bodies (NB) by the Joint Assessments from the Competent Authorities, which has led to an increase in the level of review from the NB exercise over clinical evaluation
• Introduction to MEDDEV 2.7.1, Revision 4 (2016)
• One of the largest changes in this revision, the demonstration of "equivalence" is much harder now
• Frequency for updating the CER is also much more prescriptive now and you must define and justify the frequency, based on "significant risk" of the device, as well as how "well-established"
• Manufacturers should start discussing with their notified bodies how they will start implementing these new requirements and to start performing their gap assessments and resource needs-assessments now
• Revision will lead to more clinical investigations, probably of larger size and notified bodies will be looking more closely at how all the essential requirements are met, including those with regard to usability
• How is a clinical evaluation performed?
• General considerations on updating the clinical evaluation
• The role of the notified body in the assessment of clinical evaluation reports and key changes in 2016
• Appraisal of pertinent data

Who should Attend

• CRO`s
• All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of MEDDEV 2.7.1, Revision 4
• RA Specialists
• Regulatory Affairs
• Project Leaders for MEDDEV Compliance
• Clinical Affairs
• Compliance
• Quality Control/Quality Assurance
• Distributors/Authorized Representatives
• Marketing & Sales
• Consultants
• Engineering/Technical Services
• Auditors
• Manufacturing