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93/42/EEC Medical Devices Directive 90/385/EEC Active Implantable Medical DevicesDirective

Market Surveillance in Re p u b lic of Turkey on Medical Devices Meral YILMAZ – Osman ARSLAN Ministry of Health Directorate General for Curative Services.

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93/42/EEC Medical Devices Directive 90/385/EEC Active Implantable Medical DevicesDirective

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  1. Market Surveillance in Republic of Turkey on Medical DevicesMeral YILMAZ – Osman ARSLAN Ministry of Health Directorate General for Curative Services

  2. According to Article 8 of 1/95 numbered Association Council Decisionbetween EU and Turkey, establishing the Customs Union between Turkey and EU, envisages that EU legislation on abolishing technical obstacles to trade shall be included in the internal legislation of Turkey. • According to2/97 numbered Association Council Decision between EU and Turkey the public institutions which will be harmonising the EU legislation are determined by the Cabinet Decision 15.1.1997 dated and 97/9196 numbered. meral.yilmaz@saglik.gov.tr; osman.arslan@saglik.gov.tr

  3. Council of Ministers assigned Ministry of Health for the harmonisation of the legislation on medical devices. meral.yilmaz@saglik.gov.tr; osman.arslan@saglik.gov.tr

  4. Necessary regulation for the effectively implementation of the technical legislation has been provided by 4703 numbered Act on “Preparation and Implementation of the Technical Legislation for the Products”. This act is the legal framework and it came into force on January 11th, 2002. meral.yilmaz@saglik.gov.tr; osman.arslan@saglik.gov.tr

  5. Based on this legal framework following Directives on medical devices have been harmonised by the Ministry of Health. • 93/42/EEC Medical Devices Directive • 90/385/EEC Active Implantable Medical DevicesDirective (These two regulations are in force since 31.12.2003.) • 98/79/EC In-vitro Diagnostic Medical Devices Directive (This regulation is in force since 14.04.2004.) meral.yilmaz@saglik.gov.tr; osman.arslan@saglik.gov.tr

  6. Amendments of these regulations have been republished in the official gazette on 09.01.2007. Following amendments have been realised: • Directive of 2000/70/EC on Medical Devices Incorporating Stable Derivates of Human Blood or Human Plasma, • Directive of 2001/104/EC amending the Medical Devices Directive • Council Directive of 2003/12/EC on Reclassification of the Breast Implants which amended Directive of 93/42/EEC on Medical Devices have been included in the Regulation on Medical Devices. meral.yilmaz@saglik.gov.tr; osman.arslan@saglik.gov.tr

  7. Market Surveillance activities for the medical devices are carried out by the Ministry of Health, Directorate General for Curative Services, Department of Biomedical Engineering Services. In addition to the Regulation on Medical Devices, following legislation is taken into consideration for market surveillance purposes in our country: - 4703 numbered act - Regulation on the procedure of market surveillance activities carried out by Ministry of Health meral.yilmaz@saglik.gov.tr; osman.arslan@saglik.gov.tr

  8. Market Surveillance of Medical Devices: performed by following means: • Notifications received from the natural and legal person, • Notifications received from public bodies, • Notifications received from public (media, print media etc.), • Notifications received from other countries vigilance systems, • Risk evaluation etc. meral.yilmaz@saglik.gov.tr; osman.arslan@saglik.gov.tr

  9. meral.yilmaz@saglik.gov.tr; osman.arslan@saglik.gov.tr

  10. Thank you for your kind attention. meral.yilmaz@saglik.gov.tr; osman.arslan@saglik.gov.tr

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