Improve your sales and increase customer satisfaction with medical devices that bear the CE Mark, allowing them to be legally sold within the European Union (EU) and the European Free Trade Area (EFTA). Get a clear understanding of the European directives to ensure that your products meet designated minimum safety standards and quality levels, while minimizing liability risks associated with noncompliance. Ensure your product can move freely throughout the European Single Market.

Intended for medical device manufacturers who want to export to Europe, this two-day course provides an overview of the following EU directives: Active Implantable Medical Device Directive (AIMDD), Medical Device Directive (MDD), and the In Vitro Diagnostic Device Directive (IVDD). Also covered are the requirements for safety, health, environment, and consumer protection set forth by the European medical device directives.

CE Marking, EU Directives, and Guidance Documents Course Objectives

• Understand key definitions and terms.
• Discuss how to plan for the European approval process.
• Understand the EN medical device safety assessment procedure.
• Discuss how to combine ISO 9001 and ISO 13485 with EN ISO 9004-1 using medical device guidance documents (EN 50103, EN 928).
• Describe the EU medical device vigilance program.
• Discuss the key relationships between the EU medical device directives, ISO9001/ISO13485, conformity assessment procedures, and the QSR.
• Learn how to choose a notified body for the IVDD standards.
• Understand how risk management is related to the medical device directive.
• Gain a detailed understanding of guidance documents available in the implementation of the directives.
• Understand the impact the directive will have on developing and marketing new medical device products.

• History, objectives, and structure of the EU directives and related directives
• The current medical device regulatory landscape in the EU
• The purpose of the medical device directives
• Meeting the new requirements for conformity assessment by product type

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Who Should Attend CE Marking, EU Directives, and Guidance Documents?
Designed for professionals in quality and regulatory affairs who are responsible for preparing or hosting CE Marking audits; U.S. and Canadian organizations new to the EU market; personnel performing design and risk analysis for medical devices under development; and companies preparing their own private labeling for medical devices marketed in Europe.