Quality is always the result of excellent work without compromise.
MMD-104 EU Medical Device Clinical Evaluation
Schedule and Hours
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:
Those involved in contributing information towards as well as collating information for establishment of technical documentation
QA and Regulatory Personnel
This is a 1-day programme. 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.