MEDDEV 2.7.1, Revision 4 for Clinical Evaluation and the Latest 2016 Guideline: A Guide for Manufacturers and Notified Bodies
12 Oct 2016
Webinar
Description
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
Past Events
MEDDEV 2.7.1, Revision 4 for Clinical Evaluation and the Latest 2016 Guideline: A Guide for Manufacturers and Notified Bodies - 12 Oct 2016, Webinar (62755)
Important
Please, check "MEDDEV 2.7.1, Revision 4 for Clinical Evaluation and the Latest Guideline: A Guide for Manufacturers and Notified Bodies" official website for possible changes, before making any traveling arrangements