Medical device companies wishing to market their products in the European Union must first determine the classification of their devices in accordance with rules set out in Annex IX of Council Directive 93/42/EEC. Device classification is based on the level of risk, from Class I (low risk) to Class III (high risk), and while manufacturers can self-certify certain low-risk devices, those posing a higher risk to users must have their classification verified by a Notified Body. This tiered system can lead to confusion, as device companies attempt to classify a wide variety of products.

This audio conference provides a detailed overview of the EU medical device classification system, and provides an update on the latest developments. The presentation reviews the various classes and categories, exploring the reasons and basic concepts behind them, and what they mean in terms of compliance. Using practical examples from industry, our speaker also discusses the emerging issue of classifying medical device software, as well as special devices and reclassification.

This audio conference covers:

• Basic principles of the medical device classification system in the European Union
• Classes, categories and special devices
• Purpose of classification and implications for compliance
• Review of classification rules and how to apply them
• Classification of medical device software
• Reclassification of devices

About the speaker:

Mika Reinikainen, LL.M., MBA, is Managing Director and founder of the medical device consulting company, Abnovo Ltd. Previously, he headed Quintiles Consulting Europe. Mika has more than 30 years of experience managing European medical regulatory affairs in industry, as healthcare legal counsel and as a regulatory consultant. He has also been involved directly in the development of the Medical Devices Directives – as Consultant to the European Commission and through trade associations – and of technical standards (former Chairman of CEN TC 257).

Mika is a member of the EC Medical Device Expert Group and the Working Groups on Borderlines and Classification, Software Qualification and Classification and New & Emerging Technologies. He is a founder and Chairman of the European Association of Authorised Representatives (EAAR). He directed the original development of the classification rules, wrote the first Commission guidance document on classification and has been involved in all the subsequent updates.

He holds a Master’s degree in law from the University of Nice (France) and a Master’s degree in Business Administration from Wharton (University of Pennsylvania, USA).

Who should attend?

• VP Regulatory Affairs
• Director Regulatory Affairs
• Manager Regulatory Affairs
• Quality Control/Assurance
• Sales & Marketing