Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications

The European Union (EU) provides an attractive marketplace for medical device distribution. Development of requirements harmonized across the 27 member states should make it a straightforward process to get products approved in each country - but is it? This course works through the requirements for medical devices, the steps to obtain entry into the marketplace (including setting up a number of on-going procedures and relationships), and shares some lessons learned from the Course Director, who has over 20 years of experience with CE marking medical devices for distribution in the EU.

The course will introduce the Medical Device Directives (AIMD, MDD & IVDMDD), the meaning of the CE symbol and how & when to legitimately apply this mandatory mark of conformity, the significance of Notified Bodies, Competent Authorities, and Authorized Representatives. Additionally, the significance of the QMS, ISO 13485 and ISO 14971, and reference to ISO 14000 will be explained as necessary elements in addressing the essential requirements, technical dossiers, declarations of conformity and the six steps required for manufacturers to market medical devices in the European market.

Throughout the course, examples and case studies will help participants apply the concepts being covered.

Jonathan Lee is Principal Consultant and Managing Member of MedDev Consulting Solutions International. There, he provides strategic direction and tactical solutions for unique medical-device challenges – including integration of quality systems with compliance, product performance and elevated stakeholder expectations. He has also held consulting and senior-management positions in QA/RA, R&D, project management and product introduction disciplines- both in the United States and Australia. In addition, Mr. Lee has served as an instructor on quality systems at the University of Southern California School of Pharmacy Master’s Degree Program.

A multiple patent holder, Mr. Lee possesses more than 25 years of broad-based medical device experience. His extensive quality system experience encompasses ISO, MDD & GMP standards and regulations. His prior roles include Vice-President of R&D at Cardiac Control Systems and Vice-President of Quality, Regulatory and Clinical affairs at Medtronic.

Mr. Lee’s consulting roles have supported systems in implantable bio-stimulation telemetry, implantable heart subsystems, catheter defibrillation, surgical tools and vertebral stiffness measuring. His extensive experience also includes respiratory interfaces, cardiac catheter development, medical-device processes, quality system development/implementation and product approvals.

Mr. Lee received his BE in Biomedical Electrical Engineering from the University of New South Wales, where he also completed post-graduate work in Computer Studies.

Mr. Lee has participated in compliance symposia at Harvard University.