Understanding and Implementing the Medical Device Directive
Dan O'Leary, President at Ombu Enterprises, LLC
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Note: The EU intends to replace the current directives on medical devices with a set of regulations. The negotiations are ongoing and behind schedule. This seminar covers the directives, but provides also provides information on the proposed regulations.
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 from 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.
In addition, requirements are constantly changing in the European Union. For example, the harmonized standards for quality systems and risk management (EN ISO 13485:2012 & EN ISO 14971:2012) are confusing for device manufacturers to implement. The need to keep product documentation current with updates to the harmonized standards provides an additional resource need on device manufacturers.
This interactive two-day course helps you understand the details of the MDD and implement the 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 have an opportunity to apply these concepts and principles with a large number of exercises.
The seminar addresses the details of the MDD and includes other significant issues such as the Quality Management System (EN ISO 13485:2012), Risk Management (EN ISO 14971:2012), Clinical Evaluation (MDD Annex X), and the role of harmonized standards.
Attendees receive detailed checklists that help classify devices, analyze and apply the Essential Requirements, and conduct internal quality audits.
Seminar Fee Includes:
USB with seminar presentation
Hard copy of presentation
$100 Gift Cert for next seminar
- Understand the role of product directives in the EU
- Learn the MDD medical device classification system and how to apply it
- Comprehend the conformity assessment paths and how they apply to particular devices
- Understand the MDD Essential Requirements and how to document compliance
- Learn the role of EN ISO 13485:2012 as the fundamental Quality Management System
- Understand the requirements for Risk Management and the use of EN ISO 14971: 2012
- Integrate the Clinical Requirements in the MDD into the essential requirements and risk management processes
Who will Benefit:
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
|Day One (8:30 AM - 4:30 PM)
||Day Two (8:30 AM - 4:00 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
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 “permission”
- Quality Management Systems
- Role of the FDA
- 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)
Quality Management Systems
- EN ISO 13485:2012 Medical devices – Quality management systems – Requirements for regulatory purposes
Risk Management Systems
- EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
- 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
Proposed Medical Device Regulations in the EU
Meet Your Instructor
President at Ombu Enterprises, LLC
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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