Borderline and Classification Work Group â Introduction - TOPRA

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Example of Discussion – Ovules of Lactobacillus • Tampon containing lacto-bacillus • Earlier agreement was that lacto-bacillus is a medicine • Tampons are on the market in Sweden <strong>and</strong> several countries as a medical device • Claimed to prevent fungal infection – Manufacturers claim that action is said to be competitive <strong>and</strong> not metabolic etc on the body The Organisation for Professionals in Regulatory Affairs 12
Ovules of Lactobacillus: How did they get on the market? • Notified Body consulted its CA on this product • Gained agreement that it is a medical device • Certificated the product as Class III (containing porcine gelatin) • Sweden is challenging the manufacturer – On the grounds it is not a device • Significant number of CAs agree with Sweden “not a device” The Organisation for Professionals in Regulatory Affairs 13
Page 1 and 2: Borderline and Classification Work
Page 3 and 4: Who is on the Work Group? • Chair
Page 5 and 6: Revision of MEDDEV 2.1/3 rev 2 •
Page 7 and 8: Manual of Decisions • Debates iss
Page 9 and 10: Manual of Decisions Content 3. Bord
Page 11: Currently under discussion • Near
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