About Clinical Evaluation Report for Europe and MEDDEV Expectations: Impact with New Medical Device Regulations (MDR)

Course “Clinical Evaluation Report for Europe and MEDDEV Expectations: Impact with New Medical Device Regulations (MDR)” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Why you should attend
• 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 evaluations
• 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 regarding 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
• Implement risk evaluation pre/post review
• Establish design and intended use equivalence with competitor and preexisting designs
• Identify data available from the clinical literature
• Supply and prepare documentation relating to clinical investigations that meets Notified Body requirements (if clinical investigation was deemed necessary and completed)
• Demonstrate that there is sufficient clinical data to meet the safety and performance requirements of the device
• Identify residual clinical risks and determine whether post-market clinical follow-up is required
• Maintain and update clinical evaluation documentation throughout post-market product lifecycle
• The initial creation of a CER can be a painstakingly long process, and for smaller manufacturers, can prove quite burdensome – learn how to complete a literature review report which is a comprehensive analysis of available pre- and post-market clinical data relevant to the intended use of the device and includes clinical performance and safety data
• Learn how the new MDR for Europe has a direct impact on the CER going forward
• Why CERs need to be reassessed under the new MDR
• Learn how to plan for a gap assessment to transition an organization to compliance for your CER under Europe’s Medical Device Regulation 2017/745

Who will benefit:
Personnel who want to know all aspects of the CER process and MEDDEV and the impact from the new MDR for EU. Medical device professionals in areas of quality and regulatory affairs, design, risk management, postmarket activities, R&D, and manufacturing, who work for manufacturers that market devices in the EU. 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
• Senior Management
• Regulatory Affairs Managers and RA SME’s
• Quality Managers
• Design, Development, Manufacturing and Marketing Managers
• Auditors
• Regulatory Affairs professionals
• QA/QC professionals
• Project Managers
• Compliance Officer
• Compliance Specialist
• Clinical Affairs
• Marketing & Sales Management
• Distributors/Authorized Representatives
• Legal Counsel
• Consultants
• CRO’s
• RA Specialists
• Clinical Affairs
• Project Leaders for MEDDEV and CER Compliance

For More Info visit event links:

Website of Clinical Evaluation Report for Europe and MEDDEV Expectations: Impact with New Medical Device Regulations (MDR)