DURATION:

50 min + 10 min. Question Time

Description:

The course is aimed at Quality Assurance personnel, Regulatory and Research and Development of biomedical companies, medical device manufacturers of any class, agents and distributors.

The course describes the main methods for writing an Evaluation Report of the clinical data to be included in the dossier of the product Technical according to recently introduced guide.

LEVEL: INTERMEDIATE (requires understanding of the current regulation)

Why You Should Attend:

Regulators around the world are increasing expectations for clinical evaluation of medical devices for all devices with tougher requirements for higher risk devices and especially implantables. 

Revision 4 of Clinical Evaluation guidance document MEDDEV 2.7.1 was released by the European Commission on 1 July 2016.Here Below main changes and critical points:

Clarification: Frequency of updates to the Clinical Evaluation Report (CER).

Clause 6.2.3 requires the CER to be updated at least annually for high risk or new devices, and every 2 to 5 years for lower risk, well-established devices. A justification for the frequency of updates will be required. For all risk classifications of devices, the CER will need to be updated whenever new information from the Post Market Surveillance (PMS) affects the evaluation or its conclusions.

New requirement: Qualifications of report authors and evaluators.

Clause 6.4 introduces specific requirements for the expertise and experience of CER authors and evaluators, including a relevant higher education degree and five years’ related professional experience, or ten years’ professional experience if a degree is not considered a prerequisite for the task. Deviations from these requirements should be documented and duly justified. All evaluators must now make a declaration of interest.

Clarification: Specific and measurable objectives for the CER.

Revision 3 of MEDDEV 2.7.1 required the manufacturer to document the objectives and scope of the CER, and to define these in terms of safety, performance and risk endpoints related to the Essential Requirements – but the link between scope and endpoints was perhaps somewhat buried in Appendix F, the Clinical Evaluation Checklist for Notified Bodies. Revision 4 makes the requirement for the objectives of the CER to be linked to specific safety, performance and risk-benefit endpoints clearer; detailed guidance is provided in Section 7 and Appendix 5. 1 2 3

Clarification: Establishing the state of the art.

Clause 8.2 provides more detail with respect to establishing and documenting the state of the art and available treatment options. This includes establishing the safety and performance of the device, its claimed equivalent(s), and any benchmark or other similar devices, as well as the risks and benefits of other available treatment options. Clarification: Scientific validity of data. The new revision places much greater emphasis on demonstrating the scientific validity of data, including statistical considerations. Section 9.3.1 (“How to evaluate methodological quality and scientific validity”) addresses factors which can affect the scientific validity of different types of datasets. In addition, clarifying and explanatory detail is provided throughout the guidance document for each stage of the clinical evaluation process: factors which could affect the completeness, objectivity or weight of data are described, including literature search and retrieval methods (Section 8 and Appendix 5), data appraisal and weighting (Section 9 and Appendix 6), and the analysis of data and demonstration of conformity (Section 10 and Appendix 7).

Clarification: Equivalence.

What was just a footnote in Appendix F of Revision 3 of the guidance document has been expanded considerably in Revision 4, and the requirements for demonstration of equivalence are described in detail in Appendix 1. The criteria (clinical, technological, biological) are unchanged, but more information on how this should be documented and factors which could affect the demonstration of equivalence are provided. In particular, Revision 4 requires that design differences and their impacts on clinical safety and performance be described in detail, that comparative drawings and diagrams should be provided, and that each individual device with which equivalence is claimed must meet all three equivalence criteria.

New requirement: Access to data for equivalent devices.

Revision 4 also requires that the Notified Body challenge the manufacturer’s access to data on the equivalent device(s) (Appendix A12.2.3); this is considered a transition point for the Regulation, which will require a manufacturer to have a contract in place allowing access to data for competitor devices with which equivalence is claimed.

Clarification: When is a clinical investigation required?

Appendix 2 describes key considerations relating to device risk and how manufacturers should determine if they have sufficient clinical evidence. Clarification: Risk-benefit. Appendix 7 provides detailed guidance on the analysis of data to demonstrate device safety and performance. Appendix 7.2 discusses the risk-benefit profile in particular, including the evaluation and quantification of benefits and risks, and the evaluation of the overall risk-benefit profile. The value of post-market data, and factors which could affect the statistical validity of the evaluation of this data, are addressed in some detail.

Clarification: Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF).

Throughout Revision 4 of the guidance document, the links between clinical evaluations, PMS and PMCF are reinforced. Appendix 12 highlights the requirement for Notified Bodies to ensure that PMCF is planned and appropriately justified in light of the data retrieved and conclusions documented in the CER.

Who Will Benefit:

• Quality Manager
• Quality Engineers
• Design Quality
• Regulatory Affairs specialist
• Medical Affairs specialist
• Clinical Affair specialist
• R&D Engineers
• Marketing

Certification Requirements:

Students must view the entire program and successfully pass an online, multiple choice final assessment with >80% passing grade.Certificate will be printable in PDF format immediately after satisfying requirements.

Online Training Programs Includes:

• Answer to questions submitted during the webinar.
• An online final assessment with multiple choice questions.
• A Certificate of Completion.

Live Course Presented and Commented by:

Alice Ravizza is a Biomedical Engineer, graduated at Politecnico di Milano. She has great and extensive experience in R&D and QA / RA in the biomedical field. She is specialized in supporting Medical Device companies in building up and improve Quality System Management and assure Compliance through all the internal processs. She assist companies during the registration process for CE Mark making sure all the technical documentation is compliant to applicable standards and regulations. She is aswell an experienced Trainer and Lecturer.