Call for submission of EC Classification problems relating to medical devices

Dec. 16, 2008 - PRLog -- 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: anne@qualityfirstint.com.
Participants will receive a free copy of the results published in the Journal of Medical Device Regulation if they wish.


About Quality First International:
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.

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London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace.