Icelandic Medicines Agency
The Icelandic Medicines Agency is the national authority responsible for regulation and surveillance of the development, manufacturing and sale of pharmaceuticals and other medicinal products.
Act on Medical Devices 132/2020
Medical devices shall be manufactured, used, maintained and monitored to meet the safety requirements provided for herein and in regulations issued hereunder for the purpose of protecting the life and health of users. The assembly, manufacture packaging and maintenance of medical devices shall be such that the device will perform as indicated in the manufacturer’s instructions.
For registration in the European database the Medical Director of Health shall, in accordance with Article 8 of the Act on Medical Devices, No. 16/2001, register all information about manufacturers of medical devices that are based in this country or that are responsible for marketing medical devices in this country.
The Medical Director of Health shall maintain a register for the same purpose of notifications in accordance with Article 11, cf. paragraph 2 of Article 5 of the same Act. Data shall be forwarded in a standard format. The Medical Director of Health sets more detailed rules for the collection of such data.
The registration process in the EU takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
5 years
Before placing a medical device into the market.
The oversight of the Icelandic medical device market involves vigilant monitoring to guarantee adherence to laws and regulations, as well as the fulfilment of safety and labelling requirements. The primary goal of market surveillance is to mitigate any potential risks associated with medical devices.
The responsibility for overseeing market surveillance lies with the Medical Director of Health, who is empowered to delegate specific tasks to relevant parties, as outlined in Article 10 of the Act on Medical Devices, No. 16/2001. Surveillance parties have the authority to request essential information, collect samples, and conduct necessary comments and performance tests to prevent any harm resulting from medical devices, in accordance with paragraph 2 of Article 33.
All employees of the Directorate of Health and external parties engaged by the Medical Director of Health for market surveillance are bound by confidentiality regarding matters revealed during investigations of medical devices that fall under commercial confidentiality. This confidentiality obligation persists even after the termination of employment.
Further guidance on the implementation of market surveillance, including its frequency and scope, is detailed in a regulation on surveillance by the Medical Director of Health concerning medical devices.
Under the provisions of this Regulation, instances related to devices in categories I, IIa, IIb, or III must be registered and evaluated by the Medical Director of Health, as outlined in Article 11 of Act No. 16/2001. This requirement encompasses information pertaining to:
Those involved in the manufacturing, selling, ownership, or use of devices, such as doctors, healthcare professionals, or health institutions, are obligated to report all instances specified in paragraph 1 to the Medical Director of Health, in accordance with Article 11 of the Act on Medical Devices, No. 16/2001. Subsequently, the Medical Director of Health ensures that the manufacturer of the relevant device or their recognized representative is informed about the event.
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Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
Our team will be happy to respond your queries. Contact us directly with your questions or for scheduling FREE consultation and we’ll be in touch as soon as possible.
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