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.
The IMA has the authority to designate one or more of the conformity assessment procedures described in the annexes of the medical device directives to other certified organisations. The IMA can ask the regulated party for information related to the surveillance as well as take samples, perform tests and make observations which are considered appropriate to prevent patient harm. Importers, manufacturers, sellers, owners and users should provide the needed assistance and the information that is needed and requested of them.
Medical device is defined as:
‘any instrument, apparatus, appliance, material 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:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;‘.
If there is a doubt on whether a device or an object is considered a medical device or not then the IMA will make the final decision on the classification.
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.
Vigilance and registration
Companies in Iceland that manufacture or are responsible for marketing of medical devices are legally required to register their place of business and the medical devices that they are responsible for.
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 30 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.
Laws and regulations
The laws include provisions on safety requirements, labelling, instructions for use, treatment, clinical investigation and surveillance with medical devices. With Icelands participation in the EEA, the three EU medical devices directives came into effect. These directives are:
- Directive 90/385/EEC on Active Implantable Medical Devices, which covers all powered implants or partial implants that are left in the human body. An example of this type of implant is a heart pacemaker.
- Directive 93/42/EEC on Medical Devices, which covers most other medical devices, ranging from, e.g., first aid bandages, X-ray equipment, ECG and heart valves.
- Directive 98/79/EC on In Vitro Diagnostic Medical Devices, which covers any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body. An example of this type of medical device is a pregnancy test kit.