1. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl 1 Borderline decisions – Member States cooperation Beata Koziożemska / Andrzej Karczewicz Department of Medical Devices Surveillance, Vigilance and Clinical Trials

2. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl 2 Still unresolved problems Problems with correct demarcation between medical devices, medicinal products, cosmetics and general use products is crucial for the proper implementation of directives concerning medical devices but these problems need still to be explained and resolved. According to Manual on Borderline: „Different interpretations of Community legislation occur, and, can put public health at risk and distort the internal market”. Therefore, it is very important in the context of the free movement of medical devices to be ensured and harmonized.

3. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl 3 Internal market Internal market: –harmonized decisions at the EU level –the same chance for MFR, equal treatment of MFR –uniform interpretation of definition - the same consideration of given “borderline product” Therefore, close cooperation between CAs is needed!

4. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl 4 Borderline difficulties A difficulty with consideration, whether a given product falls under the MDD, the AIMDD, the IVDD or other EU regulations arises due to among others:  the definition of medical device is very broad and ambiguous - orthopedic shoe - menthol patch - germicidal lamps - sunscreens with special indications

5. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl 5 Borderline difficulties (cont.)  lack of unanimity - 32 States - more than 32 CAs - 79 NBs (93/42/EEC)  lack of borderline decisions - vaginal ovules with Lactobacillus for gynecological use (2003) - bleaching products for teeth (2002) - glycerin suppositories (2005) - head lice products (2006) - simeticone/anti-flatulence (2008)

6. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl 6 Borderline difficulties (cont.)  ambiguous borderline decisions - microscopic slides, pipettes and mixers for IVD - products for use in acute sore throat contain Icelandic Moss  CAs do not follow to borderline decisions - instruments for tattooing (MEDDEV 2.1/1) - topic disinfectants (antiseptics) for use on patients (MEDDEV 2.1/3 rev 3) - plaster with capsaicin (Manual on Borderline) - saliva alcohol screening test for motor vehicle drivers (MEDDEV 2.14/1)

7. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl 7 Current system Current procedure –more than 200 CA Enquires, but only 41 in the Manual on Borderline –does not lead to legally binding solution –borderline decisions are issued after a very long time –sometimes borderline decisions are ambiguous

8. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl 8 Effective cooperation - what does it mean? According to the Manual on Borderline: Defining a given product as a medical device fall within the competence of the CA where the product is on its market. The Manual on Borderline does not relieve CA from its obligation to render decisions in these areas for any individual product, on a case-by-case basis. CA, acting under the supervision of the courts, must proceed on a case-by-case basis, taking account of all the product characteristics. The Manual on Borderline does not prescribe which regulation must be applied by CA to an individual product. It serves as one out of many elements supporting the CA in its case-by-case decision on individual products.

9. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl 9 Polish Act of 20 May 2010 on medical devices If a product is mistakenly taken as a medical device, or if a product is mistakenly not considered as a medical device and: - the product is placed on the market or put into service in the territory of Poland, or - the product’s MFR, AP or importer responsible for placing the product on the market has the place of residence or the registered office on the territory of Poland, or - a NB authorized by the Polish minister of health participated in the conformity assessment of the product, the Polish CA shall determine, by administrative decision, whether the product is a medical device.

10. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl 10 Wrongly affixed CE marking Where a CA establishes that the CE marking is missing in violation of the Directive or where the CE marking has been affixed in accordance with the procedures in this Directive, but inappropriately, on products that are not covered by this Directive, CA should apply Article “Wrongly affixed CE marking” of Directive. CA is not obliged to notify Commission and other CAs about applying of this Article.

11. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl 11 My questions Is a Member State independent in its borderline decision? In view of this, could we agree on different status of the same product in other countries? Is it possible to have one internal market with over 32 independent decision makers? Should CA notify the Commission and other CAs of their borderline decisions?

12. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl 12 My questions (cont.) Should Manual Decision be mandatory for CAs to existing internal market? What is the acceptable timeframe to prepare the Manual Decision necessary to enable realize CA’s tasks? What happens if member states’ courts take contradictory judgments on borderline or if courts’ judgment on borderline is inconsistent with Manual Decision?

13. THE OFFICE FOR REGISTRATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES AND BIOCIDAL PRODUCTS www.urpl.gov.pl 13 Thank you for your attention