REGULATORY ALERT: CALL FOR SUBMISSION OF EC CLASSIFICATION PROBLEMS RELATING TO MEDICAL DEVICES
Quality First International invites manufacturers to submit their experiences of classification problems involving medical devices regulated under Directive 93/42/EEC, in complete confidence

London, 16 December 2008
Click here to submit your experiences using our online submission form

The international medical devices regulatory consultancy Quality First International (QFI) invites manufacturers to share their experiences of problems involving the classification of medical devices under European Directive 93/42/EEC. In particular, QFI would like to obtain information on cases where the Competent Authority or Notified Body has disagreed with the Class of a given medical device determined by the manufacturer.

QFI is currently preparing a document entitled ‘Guidance on Principles and Practice of Medical Device Classification’ and would welcome input from manufacturers in order to illustrate problems in the interpretation and application of the classification rules. The Guidance will be published by Global Regulatory Press of London in early 2009.

The identity of the manufacturer, product and other information that could be used to identify them need not be provided if considered sensitive. Quality First International would execute confidentiality agreements if required. The information submitted would need to include:

• the type of medical device;
• whether the device is active or passive;
• the device’s intended purpose;
• its mode of action;
• the duration of contact with the body;
• the classification rule applied;
• the nature of the disagreement expressed by a Competent Authority or Notified Body;
• how the issue was resolved (if applicable);
• the CE Marking status;
• the Competent Authority concerned (i.e. the EU Member State);
• the Member State of the Notified Body concerned.

Manufacturers interested in participating in this information collection exercise should contact Mr Haroon Atchia, CEO and Technical Director of Quality First International by email via anne@qualityfirstint.com or by using our online submission form. Participants may receive a free copy of the results when they are published by Global Regulatory Press.

About Quality First International (QFI)

QFI provides a wide range of regulatory, scientific, technical and QMS consulting services, and is able to assist in queries about changes to the Directives, national transpositions (including registrations etc), as well as interpretation of the regulations. QFI operates in the UK, Germany, Israel and USA plus consults widely around the World.

For further information please contact:

Marija Capek, PR and Press Officer
Tel: +49 (0)621 166 2326
Email: marija@qualityfirstint.com
Web: www.qualityfirstint.com