Iceland Medical Device Registration

Navigating Icelandic Medical Device Regulations: Compliance, Reporting, and Assistance | IMA, Class I-IV Devices, Market Surveillance

Regulatory Authority

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.

Link for Regulatory Authority

https://www.ima.is/

Local Regulation

Act on Medical Devices 132/2020

Classification of Medical Devices

• Class I
• Class IIa
• Class IIb
• Class III

Listing or Registration Requirements

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.

Documents Required for Registration

• Data on the registration of manufacturers and recognised representatives and on devices in accordance with Article 18, except for data concerning custom-made devices.
• Data regarding certificates that are issued changed, extended, temporarily revoked, withdrawn, or denied according to the method recommended in Appendices II–VII in accompanying document 1 to this Regulation.
• Data has been collected in accordance with the vigilance procedure specified in Article 10.
• Data regarding clinical tests specified in Article 21.
• Other data that is required or that the Medical Director of Health has gathered based on this Regulation.

Registration Timeline

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.

Registration Time

https://www.ima.is/ima/fees/

License Validity

5 years

Who should make this Communication?

• Manufacturer
• Authorised representative

When to make this Communication?

Before placing a medical device into the market.

Market Surveillance

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.

Reporting Obligations for Medical Devices in Iceland: Registration and Assessment

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:

1. a) Any fault, alteration of attributes, or deterioration in the operation of a device that may or has caused the death of a patient or user, or significantly deteriorated their health. This includes mistakes in labelling or instructions for use.
2. b) Any technical or medical reasons related to the attributes or operation of devices, as described in item a, leading to the systematic withdrawal of devices of the same type by the manufacturer.

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.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: info@omcmedical.co.uk