1. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Working Group for Chapter 1 – Free movement of goods Bilateral screening: Chapter 1 PRESENTATION OF MONTENEGRO Brussels, 6 March 201 3

2. M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Working Group for Chapter 1 – Free movement od Goods- Bilateral screening: Chapter 1 Presentation of Montenegro Brussels, 6 March 201 3 Chapter 1: Free Movement of Goods

3. Chapter 1: Movement of goods M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Medical Devices Erna Šehović Agency for medicines and medical devices Department for Medical Devices erna.sehovic@calims.me@calims.me Chapter 1: Free Movement of Goods

4. Legal base Administration for medicines and medical devices launched in January 2008. in accordance with the Law on Medicines in 2004 (Official Gazette of RM No. 80/04) and the Law on Medical Devices of 2004 (Official Gazette of Montenegro ", no. 79/2004 In accordance with the amendments to the Law on Medicinal Products (Official Gazette of RM No. 18/08), 01.01.2009. the Agency for Medicinal Products and Medical Devices of Montenegro was founded as an independent regulatory authority Chapter 1: Free Movement of Goods M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free Movement of Goods

5. Institutional framework Goverment of Montenegro Ministry of health (in charge for legal framework) Agency for medicines and medical devices ( in charge for medicines, medical devices and narcotic substances) Administration for inspection affairs Supervision over Law implementation Chapter 1: Free Movement of Goods M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free Movement of Goods

6. Legal framework for medical devices Chapter 1: Free Movement of Goods M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free Movement of Goods Law on Medical Devices, Official Gazzette Of the Republic of Montenegro No 79/2004 Law on Changes and Amendments to the Law on Medical Devices, Official Gazzette of Montenegro No 53/09

7. Law on Medical Devices determines terms of marketing Agency maintains registers of manufacturers, entities performing wholesale, import of medical devices and register of specialised stores for a retail of medical devices Only persons entered into the register may perform marketing and import of medical devices Agency also maintains a register of medical devices Medical devices that have Declaration of Conformity or a certificate of Conformity; issued by authorised Notified body, are entered into the register on the basis of certificates – no testing is required Chapter 1: Free Movement of Goods M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free Movement of Goods

8. Application for entry of a medical device in the Register of Medical Devices shall be submitted to the Agency by: manufacturer with its main office in Montenegro or entity representing foreign manufacturer (an authorized representative) Applicant will be held responsible for documentation required by the procedure of registration of a medical device in the Register of Medical Devices. Emergency import – for urgent medical need, in order to protect public health. Chapter 1: Free Movement of Goods M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free Movement of Goods

9. Agency performs the classification of medicinal products or medical devices. Agency organizes and conducts vigilance of marketed medical devices by collecting information f ro m authorised representative, health care professionals, wholesales or manufactures. Chapter 1: Free Movement of Goods M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free Movement of Goods

10. Keeping the register of medical devices ensures daily usage of medical devices that meet these standards which contributes to higher level of quality of health service, which is the goal of the Agency Entering into the register enables the Agency to have insight into the all of medical devices on the market and to conduct surveilance over them. The list of medical devices that entered into the register : http://calims.me/Portal/faces/dinamickeStrane?_adf.ctrl- state=15m1q9kzf6_4&_afrLoop=4534446820861258 Chapter 1: Free Movement of Goods M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free Movement of Goods

11. Planned activities Challenge: to create an efficient market able to adapt to the EU goals for creation of unique market in this area. Chapter 1: Free Movement of Goods M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free Movement of Goods The goal is full compliance with EU standards (New Law on Medical Devices

12. Planned activities Beside this Law, following documents are also in preparation: Rulebook on the classification of general medical devices. These activities are based on: the provisions of EU directives from the field of medical devices (90/385 EEC, 93/42 EEC, 98/79 EC,2007/47 EC) EU guideline on the classification of medical devices (Guidelines Classification of Medical Devices MEDDEV 2.4/1 Rev.9, June 2010) Chapter 1: Free Movement of Goods M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free Movement of Goods

13. Reclassification of hip, knee and shoulder joint replacements: - Directive 2005/50/EC - OJ L 210/41 of 12/08/2005 Reclassification of breast implants: - Directive 2003/12/EC - OJ L 28/43 of 4.02.2003 will be fully implemented within this Rulebook. Rulebook on the vigilance of medical devices These activities are based on EU guidelines - Guidelines on a medical devices vigilance system MEDDEV 2.12/1 rev. 6 Chapter 1: Free Movement of Goods M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free Movement of Goods

14. In relation to new Law on Medical Devices, due to specificities of legislation, all matters that may not be prescribed by the Law will be defined by secondary legislation so that montenegrin legislation is complied with legislation of EU in the field of medical devices. System Efficiency: harmonization of legislation with EU standards and is not only and satisfying task. The main goal is to achieve full efficiency of the system established by law. To ensure safe medical devices on the market. Chapter 1: Free Movement of Goods M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free Movement of Goods

15. The need to be in the area of medical devices setting health protection standards that meet the highest European standards, as well as in the industry and other stakeholders in the health care and marketing of medical devices provide better conditions for development, prosperity and competitiveness. We would like to complete fiar balance between regulation, control and freedom. Chapter 1: Free Movement of Goods M O N T E N E G R O Negotiating Team for the Accession of Montenegro to the European Union Chapter 1: Free Movement of Goods

16. Thank you for your attention! QUESTIONS