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Implementation - Medical Devices

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

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Implementation - Medical Devices

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  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. Act on Medical Devices NO 16/2001 - background • 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.

  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.

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