1. Implementation - Medical Devices

2. Overview Act on Medical Devices – background and overview. Surveillance - Competent authority. Directive 93/42. Directive 90/385. Directive 98/79. Answers to questions.

3. Competent authority for Medical devices and surveillance. Directorate of Health is the competent authority for medical devices and is responsible for surveillance of the safety of medical devices. Directorate of Health co-operates with The Consumer Agency in market surveillance. A legislative proposal is pending before the Parliament on the transfer of surveillances of medical devices to the IMA.

4. Framework Act. Came into effect 2001. Lex specialis. Legal base for implementation Directives 90/385 and 98/79. Gives the government power to implement future directives with a regulation. Act on Medical Devices NO 16/2001 - background

5. Act on Medical Devices NO 16/2001 - overview Scope: applies to the manufacture, sale, marketing, market surveillance, maintenance and use of medical devices. Objective: ensure the safety of users of medical devices. Main subject: –Safety requirements. –Labelling. –Instruction for use. –Treatment and registration. –Clinical Investigation. –Surveillance. The Act needs revision.

6. Directive 93/42 Implemented first in 1994 (Regulation 368/1994). –Method of references. Regulation 892/2004 on Medical Devices in 2004. –Implements Dir: 93/42, 2000/70, 2001/104 and 2003/12 –Amendment in 2006. Implements Dir: 2003/32 and 2005/50. New Regulation 943/2010 on Medical devices issued in December 2010. Implements the abovementioned Directives and Directive 2007/47

7. Directive 90/385 Implemented by Regulation 476/1994. Method of references. New Regulation on active implantable medical devices published in December 2010. Further implementations: –Directive 93/68 –Directive 2007/47

8. Directive 98/79 Early next year a regulation will be issued.

9. Question 1 and 2 Does Iceland deem that its national law transposes completely and correctly the EU acuis for medical devices? –Generally Directive text and wording used in regulations. –Thus revision not deemed necessary (answer to question 2)

10. Question 3 What are Iceland’s plans for modifications in the field of medical devices. –No plans for modifications in sight except for the transfer of surveillance to the IMA.

11. Question 4 What are the human resources available for market surveillance and vigilance? –1-2 persons responsible for market surveillance and vigilance.