1- Day Training for RA/QA Professionals of the MD Industry
CER under the EU MDR 2017/745
California | April 23, 2019 | Register Now !
About the training
All medical devices sold into Europe, new or existing, and irrespective of specification, must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File. However, despite the CER being a critical compliance element for medical device manufacturers doing business in the EU, there continues to be significant lack of clarity regarding key requirements and best practices for creating these reports. Without a clear understanding of what is required, both manufacturers and Notified Bodies (NBs) struggle to apply a consistent approach to the CER process.
Now that the new Medical Device Regulation (MDR) has come into force in the EU, there is even greater emphasis on providing supporting clinical data, combined with the need to suitably plan CERs and fully document the approach and process.
To seamlessly manage the CER process so that clinical data is regularly updated without causing major bottlenecks, or stalling, in productivity, it is critical that manufacturers establish a clear strategy towards CERs.
Therefore, GMED North America has created a 1-day training session, to equip medical device manufacturers with the right strategy to ensure their CER processes can withstand heightened scrutiny from NBs.
During this 1- day course, you will learn about:
- The key changes for clinical data under the EU Regulation 2017/745 (MDR)
- What is considered sufficient clinical data for clinical evaluations
- Clinical Investigation Requirement
- Post- Market Surveillance Requirements (PMS), Post- Market Clinical Follow- Up (PMCF), and Periodic Safety Update Report (PSUR)
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Keywords: Post- Market Surveillance Requirements (PMS), Post- Market Clinical Follow- Up (PMCF), and Periodic Safety Update Report (PSUR) European Medical Devices Regulation 2017/745, Quality Management System (QMS) , Essential Principles, Technical File Documentation, Regulatory Requirements, Compliance, Risk Management, Clinical Evaluation and Clinical Data, Post Market Surveillance, Vigilance reporting. CER,
WHO SHOULD ATTEND
- Medical Device Manufacturers: Senior Management , Regulatory Affairs Managers and Quality Managers, R& D specialists, Development, Manufacturing and Marketing Managers,
- Internal and external Auditors
- Good knowledge and effective practice of the Directives 93/42 / EEC or /and 90/385 / EEC
The number of participants is maximized to fifteen to provide a stimulating and practical working environment.
- Practical working sessions
- Course evaluation
- Lunch meeting with the trainer ( Lead Auditor and Technical File Assessor for high risk devices)
- Understand the key changes for clinical data under the EU Regulation 2017/745 (MDR)
- The expectations with the use of the Essential requirements
- Understand and learn how to read the Classification Criteria and Implementation rules
- Identify the applicable conformity assessment routes for your device(s),
- Identify the impacts on the Technical Documentation
- Assess the expectations and requirements with regard to Clinical Data and Clinical Evaluation
- Identify the Post market surveillance and reporting requirements in the MD
8:30 am to 9:00 am - Breakfast
9:00 am – 12:15 pm:
- Changes for definitions between MDR and MDD
- Appraisal of clinical data
- Analysis of clinical data
- Post-market surveillance requirements, including PMCF and PSUR
- Unique Device Identifier and Eudamed
- Summary of safety and clinical performance (Article 32)
- Expert panel consultation (Articles 61 section 2)
12:15 pm – 1:00 pm - Lunch
1:00 pm – 5:00 pm:
- Practical working sessions
- Group workshop
- Course Evaluation
- Summary and Discussion with the trainer
|About the trainer|