About Medical Devices

The IMA is the competent authority (CA) for medical devices and monitors and ensures compliance with medical device legislation in Iceland. The goal of the surveillance is to prevent patient harm and to help ensure that production, maintenance and use of medical devices is according to latest standards and guidelines.

The monitoring of medical devices is performed by doing post-market surveillance and by operating an inspection programme to make sure that medical devices are maintained and used correctly.

Definitions

Medical device is defined as:

any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

  • diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

  • investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

  • providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. The following products shall also be deemed to be medical devices:

  • devices for the control or support of conception;

  • products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

Use

All medical devices should include information on manufacturer and required guidelines on safe an effective use, which should take into account the level of education and knowledge of potential users. These guidelines should be located either on the device itself or on it its packaging. The languages of the guideline should be clearly specified and in these cases where patients themselves operate the medical device the guidelines should be in Icelandic depending on the risk classification of the device according to regulation on instruction for use for medical devices intended to be used by the public nr. 789/2021.

Vigilance and registration

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

Manufacturers or companies that are responsible for medical devices in Iceland are furthermore required to do post marketing surveillance and report any adverse events related to such devices to the IMA.

Everyone who either sells, owns or uses in his profession medical devices is required to report adverse incidents involving a medical device.

The following serious adverse events which can be related to the use of CE marked medical devices should be reported to the IMA as well as the party responsible for the medical device.

  • Adverse incidents which causes the death of a patient or user.
  • Adverse incidents that cause serious harm to patient or user.
  • Adverse incidents which might cause the death of a patient or user or which might cause serious harm to patient or user.

If a manufacturer has received information that a medical device has caused or might have caused an adverse incident the manufacturer is required to inspect the seriousness of the adverse incident and send the IMA a report within the following time limits.

Serious risk to public health: REPORT IMMEDIATELY or within 2 days because of special circumstances.

Death or serious harm to patient: REPORT IMMEDIATELY or within 10 days because of special circumstances.

Otherwise:  REPORT IMMEDIATELY or within 15 days because of special circumstances.

If a manufacturer delays sending in adverse incident reports then he needs to be able to rationalize the delay. The IMA reviews these reports and takes appropriate measures.

 The IMA is cooperating with other competent authoritites on medical devices within the EEA on post-market surveillance. The IMA sends and receives reports on incidents and faulty devices from these authorities and takes appropriate measures.