The newly revised European Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) come into effect on March 21, 2010. There is no transition period, which means that medical devices placed on the market or put into service as of that date will be expected to comply with the revised directives. Some of the most important revisions concern clinical data and clinical evaluation, and the types of adverse events that must be reported if they occur during the clinical study.

In this audio conference, the speaker reviews these changes to the directives, their relationship to ISO 14155, and explores effective ways to prepare for compliance.

This audio conference covers:

• New and clarified EU clinical data and clinical evaluation requirements
• New requirements for adverse event reporting during clinical studies
• What notified bodies will likely be checking during their assessments
• The current status of ISO 14155 and its relationship to the new EU requirements
• European and global harmonization guidance documents on clinical evaluation

About the speaker:

Dr. Maria Donawa has nearly 30 years of regulatory experience. From 1980 to 1986, she worked with the US Food and Drug Administration in the area of medical device regulation. In 1986, after moving to Rome and working initially as an independent consultant, she founded Donawa Lifescience Consulting (DLC), headquartered in Rome, with locations in the UK, Switzerland and the US. The firm is a full-service European CRO for medical device and drug clinical studies, and provides a complete range of device and drug regulatory and quality system services.

Dr. Donawa is a current member of ISO TC 194 Working Group 4, which developed and is revising ISO 14155, the medical devices clinical study standard, and ISO TC 210 Working Group 1, which developed and revised ISO 13485, the quality system standard for medical devices. She holds degrees in pharmacy and medicine, with a post-doctoral specialty in clinical and anatomical pathology.

Who should attend?

• Clinical Affairs
• Regulatory Affairs
• Clinical Operations
• Medical Device Executive Management

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.