Clinical Evaluation and the Latest 2016 Guideline

Description: 
This “General Guidance” document promotes a common approach to clinical evaluation for "medical devices regulated by directives 90/385/EEC and 93/42/EEC. It does not concern in vitro diagnostic devices. The depth and extent of clinical evaluations should be flexible and appropriate to the nature, intended purpose, and risks of the device in question. Therefore, this guidance is not intended to impose device-specific requirements. The Clinical Evaluation Report (CER) is a living document required for the EU market for all classes of new and existing devices, detailing the clinical evaluation of a product throughout its life-cycle. While the requirement to have a CER is not new, it is subject to more intense scrutiny by Notified Bodies in the conformity assessment phase, and CERs are increasingly being assessed in the post-market phase. This revised MEDDEV is being generated within a context of increased scrutiny on the Notified Bodies. The revision of this document represents a complete re-write of this MEDDEV, with many new Appendices and much new guidance. The new MEDDEV can be considered more instructive, but also more prescriptive in particular regarding the use of evidence from equivalent devices.

Areas covered in the session:
•    Introduction to MEDDEV 2.7.1, Revision 4 (2016)
•    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 the NB exercise over clinical evaluation
•    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”
•    One of the largest changes in this revision, the demonstration of “equivalence” is much harder 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
•    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. 
•    General considerations on updating the clinical evaluation
•    How is a clinical evaluation performed?
•    Appraisal of pertinent data
•    The role of the notified body in the assessment of clinical evaluation reports and key changes in 2016
•    Other changes and revisions of this document and represents a complete re-write of this MEDDEV, with many new Appendices and much new guidance

Who will benefit:
This webinar will provide valuable and additional insight and an overview for the medical device and IVD companies involved in establishing and maintaining a state of compliance and meeting compliance deadlines for UDI.

Employees and personnel who will benefit include: 

•    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
•    CRO’s 
•    Regulatory Affairs
•    RA Specialists
•    Clinical Affairs
•    Project Leaders for MEDDEV Compliance 
•    Quality Control/Quality Assurance
•    Compliance
•    Marketing & Sales 
•    Distributors/Authorized Representatives
•    Engineering/Technical Services
•    Consultants
•    Manufacturing 
•    Auditors

Instructor Profile:

David R. Dills, Global Regulatory Affairs & Compliance Consultant currently provides regulatory affairs, compliance and quality consultative services for early-stage and established Class I/II/III device, In Vitro Diagnostics, cosmetics and bio/pharmaceutical manufacturers on the global landscape, and also has an accomplished record with more than 25 years of experience in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO and has worked directly with manufacturers engaged in compliance remediation activities and services involving consent decrees, CIA’s, warning letters, 483 observations, and customer generated compliance events, and prepares for and conducts QS and regulatory audits.  
He has been directly involved with constructing, reviewing, and/ or remediating regulatory submissions, including 510(k), PMA, IDE applications, IND, BLA and NDA submissions, preparing Supplements, Amendments, U.S. Agent, works closely with the key stakeholders  and Agency/Center Reviewers regarding submission meetings and negotiations; clinical affairs and study submissions; and provides regulatory submissions and post-market project leadership and guidance covering different therapeutic and medical specialties based on classification.  

For More Details:https://www.grcts.com/GRC-90067

Email:david@grcts.com | Tel:+1-248-233-2049 | Web:www.grcts.com