MEDDEV 2.7.1, Revision 4 for Clinical Evaluation and the Latest 2016 Guideline: A Guide for Manufacturers and Notified Bodies
Duration: 60 Minutes
This webinar will explore the key changes, discussing the new requirements and noting the main clarifications within the guidance document. It will highlight the areas for you to be aware of and consider when conducting clinical evaluations.
The new revision is beginning to align with the European Medical Device Regulation, transition to which will require conformity to the requirements of the new Revision of this guidance.
Objectives of the Presentation
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.
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:
Bookmark
Email this page
Download AgendaObjectives of the Presentation
- 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 from 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
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.
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