Understanding and Implementing the Medical Device Directive

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	Course "Understanding and Implementing the Medical Device Directive" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Most medical devices marketed in the European Union must follow the Medical Device Directive (MDD); IVD device and active implantable devices have other directives. The MDD can be complicated, especially for US companies, because the MDD’s approach is different than the regulatory approach in the US. For example, under the MDD your company makes “submissions” to a private company that you hire, not to a government agency.

This interactive two-day course will help you comprehensively understand details of the MDD and implement its requirements. Attendees will learn how to classify devices, select the appropriate conformity assessment path, prepare the required documentation, and maintain it. During the course, participants will have exercises that apply the principles and help solidify learning.

The instructor addresses the details of the MDD and includes other significant issues such as the Quality Management System (ISO 13485), Risk Management (ISO 14971), Clinical Evaluation (MDD Annex X), and the role of harmonized standards.

Course Objectives:

Understand the role of product directives in the EU
Learn the medical device classification system and how to apply it
Comprehend the conformity assessment paths and how they apply to particular devices
Understand the Essential Requirements and how to document compliance
Learn the role of ISO 13485 as the fundamental Quality Management System
Understand the requirements for Risk Management and the use of ISO 14971
Integrate the Clinical Requirements in the MDD into the essential requirements and risk management processes

Course Outline:

Day 1

Day 2

Medical Device Directives

Development, aims, and implementation of medical device directives in the EU
The application and differences of the directives that cover medical devices
- The Medical Device Directive (MDD)
- The Active Implanted Medical Device Directive (AIMDD)
- The In Vitro Diagnostic Medical Device Directive (IVDD)
Relationship to other product directives
- Machinery Directive
- Personal Protective Equipment Directive

Compare & Contrast EU & FDA Procedures and Requirements

Device classes
Marketing “approval”
Quality Management Systems
Role of the Notified Body

Understanding the MDD

Medical device classification in the EU (by directive)
Software as a medical device

Technical File and Design Dossier

Constructing and maintaining the documentation
Auditing and sampling by the Notified Body

Annex I – Essential Requirements

Using harmonized standards to satisfy the Essential Requirements

Conformity assessment paths in the directives

Compliance Options by Device Class
Annex II – Full Quality Assurance System

Information Provided by the Manufacturer (Labeling & IFU)

MDD Annex I, Essential Requirements, Section 13
EN 980:2008 Symbols for use in the labeling of medical devices
EN 1041:2008 Information supplied by the manufacturer of medical devices

Quality Management Systems

EN ISO 13485:2003/AC:2009 Medical devices – Quality management systems – Requirements for regulatory purposes

Risk Management Systems

EN ISO 14971:2009 Medical devices – Application of risk management to medical devices

Clinical Evaluation

Clinical Evaluation (MDD Annex X & MEDDEV 2.7-1)

Post Market Surveillance

Medical Device Vigilance System (MEDDEV 2.12-1)

Safety and Surveillance

Creating a unified approach during the development and production phases
Creating a unified approach for activities after delivery

This course benefits anyone involved in quality or regulatory compliance for medical devices marketed in the European Union and is ideal for quality, regulatory, and clinical professionals working in the health care, clinical trial, biopharmaceutical, and medical device sectors.

Regulatory Managers
Quality Managers and Directors
Marketing Managers
Clinical Managers
Export Compliance Managers

Dan O’Leary
President, Ombu Enterprises, LLC
Medical Devices

Dan O’Leary has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

Dan is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. Dan is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.

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Cancellations and Substitutions
Written cancellations received at least 15 calendar days prior to the start date of the event will receive a refund — less a $150 administration fee. No cancellations will be accepted — nor refunds issued — within 15 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future ComplianceOnline event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.