European borderline classification issues

As an update to an email we sent in April, another version (1.1, May 2008) of the Manual on Borderline and Classification in the EU Community has been published.

Manual on Borderline and Classification in the Community
Regulatory Framework for Medical Devices, Version 1.1 (May 2008)

Here is a link to the PDF document:
http://ec.europa.eu/enterprise/medical_devices/wg_minutes_member_lists/m...

(This is a long URL string so if you have problems with the link, copy and paste the entire link into your browser window.)

Version 1.1 adds approximately ten new examples. While this is guidance and many of the products may not be relevant, they do provide examples and capture the opinions of various regulatory officials.

One example of note is the classification of different types of Picture Archiving and Communication Systems (PACS).

• PACS for only archiving or storage may not be a medical devices
• PACS for viewing, archiving, and transmitting images may be Class I (Rule 12) medical device.
• PACS for post-processing of the image for diagnostic purposes (post processing which alters image data: filtering, multiplanar reconstruction, 3D reconstruction) likely Class IIa (Rule 10) medical device.
• PACS which drives or influences source same class as source device (Implementing Rule 2.3).
• PACS with image enhancement or control image acquisition same class as source device Class IIa or Class IIb (Rule 10).

Other examples:

• Single or multiple channel pipettes
• In-Vitro Fertilization (IVF) and Assisted Reproductive Technologies (ART) products
• Hand disinfectants
• Surgical instrument decontamination products
• Dental water line disinfectants
• Blood refrigerators, freezers and defrosters
• Warming blankets
• Products evaluating the condition of respiratory muscles
• Neutral electrodes for high frequency surgery

We hope you find this information useful. Also, you may want to check out the Learning Library section of our all new website as we have added new regulatory information for China and Japan.

http://www.emergogroup.com/learning-library

Best regards,

Evangeline Loh, PhD, RAC
Director of Regulatory Affairs
Emergo Group, Inc.