Borderline and Classification Work Group â Introduction - TOPRA

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What does the Work Group Work on? • Revises Meddev 2.1/3 on demarcation between medical devices and drugs – to take account of 2007/47 – Includes procedure for consultations on combination products • Debates issues about – Borderlines • Is it a medical device? If not why not? – Classifications • If it is a device, what class is it? – Results are in a “Manual of Decisions” • http://ec.europa.eu/enterprise/medical_devices/borderline_classificati on_en.htm – Revision of Meddev 2.4/1 Guidelines for Classification of Medical Devices to align with “new” directive The Organisation for Professionals in Regulatory Affairs 4
Revision of MEDDEV 2.1/3 rev 2 • Aim is to align with “new” medicines directive • Commission removed examples from the old version – MS argued to put them back • All parties found them useful – Debate ongoing • Currently in the Manual of Decisions The Organisation for Professionals in Regulatory Affairs 5
Page 1 and 2: Borderline and Classification Work
Page 3: Who is on the Work Group? • Chair
Page 7 and 8: Manual of Decisions • Debates iss
Page 9 and 10: Manual of Decisions Content 3. Bord
Page 11 and 12: Currently under discussion • Near
Page 13 and 14: Ovules of Lactobacillus: How did th
Page 15 and 16: Conclusions on the Manual of Decisi
Page 17: In conclusion • Who is on the Wor

Borderline and Classification Work Group â Introduction - TOPRA

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Borderline and Classification Work Group â Introduction - TOPRA