Act on Medical Devices No 16/2001

This Act applies to the manufacture, sale, marketing, market surveillance, maintenance and use of medical devices and surveillance by health authorities of such devices.

The objective of this Act is to prevent damage to users of medical devices and to ensure that the production, maintenance and use of medical devices is consistent with the best available professional expertise at any time.

For the purpose of this Act:
1. Medical device: means any instrument, apparatus, appliance, material (excluding medicinal products) or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of
1. diagnosis, prevention, examination, treatment or alleviation of diseases,
2. diagnosis, monitoring, treatment, alleviation or compensation for an injury, handicap or impaired capacity,
3. investigation, change or replacement of an organ or of a physiological process,
4. prevention of conception.
A device which forms part of a medical device, or which is in any other way connected with the use of a medical device shall also constitute a medical device.
A device which primarily has an effect on or in the human body by pharmacological, immunological or metabolic means does not constitute a medical device, although it may form part of a medical device.
In the event of any doubt as to whether a device or item constitutes a medical device, the Directorate of Health shall decide.
2. Manufacturer: means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.
A natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name, shall constitute a manufacturer.
A person who assembles or adapts devices already on the market to their intended purpose for an individual patient shall not constitute a manufacturer.
3. User: means a person who needs a medical device owing to a disease, handicap or impaired capacity, who works with medical devices or who is responsible for their supervision and/or maintenance.
4. Clinical investigation: means research on humans for the purpose of obtaining information and/or verifying that medical devices, in normal use, conform to basic requirements on characteristics and performance, as provided for in the EU Directives which form a part of the Agreement on the European Economic Area. Clinical investigations include assessment of undesired side-effects of medical devices.

Medical devices shall be manufactured, used, maintained and monitored so as 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.
A medical device may only be placed on the market and taken into use if its design, manufacture and packaging does not pose a risk to the user.
The same provisions shall apply to medical devices which are designed and manufactured within health institutions.

Before a medical device is placed on the market, sold or taken into use, it shall be labelled pursuant to the rules of the European Union on medical devices, which are part of the Agreement on the Economic Area, or pursuant to requirements laid down in agreements which Iceland has entered into with parties outside the European Economic Area.
The Directorate of Health may remove a medical device from the market, even if it is labelled in accordance with Paragraph 1, if it appears that the device has dangerous qualities.
An exception may be granted from Paragraph 1 in respect of devices which are intended only for display at trade fairs, exhibitions, in demonstrations etc., for clinical testing, cf. Article 9, or which are custom-made for an individual person.

All medical devices shall be accompanied by necessary information from the manufacturer and instructions for safe use. Instructions needed to use the device in a safe manner shall, to the extent possible, be included on the device itself and/or on its packaging. Medical devices intended for the use of the public shall be accompanied by instructions in Icelandic.

The owner of a medical device is responsible for its correct use and the qualifications of the user. Furthermore, the owner shall ensure adequate disposal and storage and that maintenance and repair services are carried out by authorised party in such a way that the safety of the user is ensured.

The Directorate of Health shall maintain a register of parties operating enterprises in Iceland which manufacture medical devices or are responsible for the marketing of such devices.

The manufacturer shall submit an application for clinical testing of a medical device to the Directorate of Health, which shall ensure that the conduct of the investigation is compatible with rules of good practice and rules on patients' rights, including provisions on research and on the evaluation of the Science Ethics Committee.
The Directorate of Health may halt the conduct of clinical investigation in the event of non-observance of the terms governing clinical investigations.

The Directorate of Health is responsible for surveillance of the safety of medical devices. Surveillance refers, on the one hand, to market surveillance, i.e. ensuring that medical devices placed on the market comply with safety requirements and requirements on labelling pursuant to Article 5, and on, the other hand, surveillance of proper maintenance of medical devices and of the use of medical devices. The Director or Public Health may assign part of this surveillance to other parties.
Surveillance bodies may request necessary data for their surveillance, take samples and carry out the investigations and tests regarded as necessary to prevent damage caused by medical devices. Manufacturers, importers, sellers, owners and users of medical devices shall provide the assistance and information needed and requested at any time.

Parties who manufacture, sell, own or use medical devices and are aware of deviations, defects or non-functionality which could cause or has caused damage to the health of a user, or death, is under obligation to notify the Directorate of Health.

Importers and manufacturers shall pay a service fee in respect of market surveillance, cf. Paragraph 1 of Article 10, and for evaluation of applications for clinical investigations of medical devices, cf. Article 9, pursuant to a tariff issued by the Minister on the recommendation of the Directorate of Health. The tariff shall be based on the cost of the service.

Procedure and legal recourse of surveillance authorities pursuant to Article 10 shall be subject to Article 10 of Chapters IV and V of Act No. 134/1995 on product safety and public market surveillance, as applicable.
Legal issues arising in respect of violations of this Act shall be subject to rules on public prosecution.

The Minister may, by government regulation, provide for the further implementation of this Act, e.g. as regards the safety of medical devices, labelling, instructions for use, registration, clinical investigation and the obligation to notify.

This Act shall enter into force immediately.
At the same time, Article %, Paragraph 5 of the Act on Medicinal Products shall be deleted.

Medical devices which are labelled in accordance with Council Directive 76/764/EC may be placed on the market, sold or used until 30 June 2004.
Devices for biosample analysis meeting safety requirements prior to the entry into force of this Act may be placed on the market, sold or taken into use until 7 December 2003.

This Act shall be subject to review within five years of their entry into effect.