MMD-104    EU Medical Device Clinical Evaluation

• Overview
• Course Objectives
• Course Content
• For Whom
• Schedule and Hours

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A clinical evaluation needs to be conducted on each medical device type or family by the manufacturer in order to allow the medical device to be legally placed in certain regulated markets. This is a mandatory prerequisite regardless of the risk classification. The collation of clinical data is a key aspect of the EU CE Marking conformity assessment process. It allows the manufacturer to substantiate safety, performance and benefit/risk assessment claims made.
 
Revision 4 of the MEDDEV guidance document 2.7/1 was released on 1st July 2016. This new version includes new requirements and is aligned with the EU Medical Device Regulations and also covers requirements specifically for Post-Market Surveillance (PMS), and Post-Market Clinical Follow-Up (PMCF).
 
Participants will be led by an experienced trainer whom, in addition to being a CE Marking auditor and technical file reviewer, has nearly 3 decades of assessment, training and quality assurance as well as management system development experience. Participants will be able to determine if a clinical trial is required, prepare a clinical evaluation report including literature review and determine requirements for post-market clinical follow-up and post-market surveillance.

• Determine whether or not a clinical investigation is required for their device
• Prepare a clinical evaluation in accordance with MED DEV 2.7.1 and GHTF Guidance Documents
• Implement risk evaluation pre/post review
• Establish design and intended use equivalence with competitor and pre existing designs
• Supply and prepare documentation relating to clinical investigations that meets Notified Body requirements
• 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

• Considerations in determining as to whether clinical trials/ investigation are required for a particular medical device
• Clinical Evaluation requirements as specified in MEDDEV 2.7/1 rev.4
• GHTF/IMDRF guidance on Clinical Evaluation
• Pre and Post Review Risk Evaluation
• Aspects of design and intended use equivalence
• Clinical Literature reviews
• Notified Body expectations on Clinical Evaluation documentation submissions
• Clinical data in meeting the General Principles of Safety & Performance
• Post Market Clinical Follow-ups and residual clinical risks

Those whom contribute towards ensuring the medical device meet regulatory requirements for risk management as well as those whom conduct change management, including:

• Management representatives
• Those involved in contributing information towards as well as collating information for establishment of technical documentation
• QA and Regulatory Personnel
• Internal Auditors

This is a 1-day programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.