Medical Device Regulation: US FDA, European MDD and CE Marking

Manufacturing and marketing of different Medical Devices must be performed in respect to European and/or American regulations and to ISO Standards.

 Know and understand regulatory environments (21 CFR 8xx, 510k, Directives 90/385, 93/42, 98/79, ISO 13485:2003).

 Control the elements of the PreMarket Approval file for USA. Understand the principles of EC conformity evaluation and the documentation structure associated.

 Understand American and European Vigilance systems.

1. Stakes of Medical Devices Regulations

Risks linked to Medical Devices (client risks / supplier risks). Presentation of European (CE) and American regulatory environments. Main differences between the two systems.

2. Medical Devices CE Marking Regulation

Scope and principles of the 3 European Directives. Classification principles. Notion of CE Marking. Limits and grey areas of European Directives. European system for Vigilance: 0rganization, Manufacturer and distributors responsibilities. Implementation of the Directives: Manufacturer and Notified Body roles, chronology of implementation, technical documentation.

3. EC Conformity Assessment

Various approaches for EC Conformity: from EC declaration to implementing a full quality assurance system. Impacts in terms of assessment. Choice of the approach adapted to your product and company.

4. Details of ISO 13485:2003

Regulation scope and application. Perimeter, responsibilities, Quality Assurance system and its monitoring. Requirements linked to Design, Validation, Manufacturing, Purchasing, and Quality Control. Documentation Requirements. Requirements linked to Packaging, Handling, Storage, Distribution, After Sale Service, Customer Complaints. Technical Documentation Requirements.

5. FDA Regulatory Environment: Introduction and classification

History of American Regulation. Principles of FDA classification Differences with EC classifications. Applicable Controls according to classification. Classification change management: Why? How?

6. Required Documentation to Export towards USA

Establishment Registration and Medical Device Listing. PreMarket Notification: 510(k). Content of Marketing Files: PreMarket Approval (PMA), Clinical Trials File, accompanying and tracking documents.

7. 21 CFR 8xx Regulation, and focus on 21 CFR 820

Anwendungsbereich der Regelung. Regulation Scope and Application. Perimeter, responsibilities, Quality Assurance system and its monitoring. Implementation of Continuous Improvement Tool (Feedback). Requirements linked to Design, Validation, Manufacturing, Purchasing, and Quality Control. Documentation Requirements. FDA files: Design History File (DHF), Device Master Record (DMR), Device History Record (DHR), Quality System Record (QSR). Requirements linked to Packaging, Handling, Storage, Distribution, After Sale Service, Customer Complaints. Technical Documentation Requirements. FDA File for Medical Device Reporting (MDR).

8. Know how to approach a FDA Inspection.

9. Differences between EC Directives, FDA Regulations, ISO 13485:2003, and ISO 9001:2008

Main differences between 21 CFR 820, ISO 9001:2008 and ISO 13485:2003. Gap to fill in for a company which has a CE Marking and who wants to expend its market to USA.

A Multiple Choices Questionnaire is proposed at the end of the training session in order to evaluate the acquired knowledge.