All medical devices with the exception of custom-made medical devices and medical devices undergoing clinical trials should have the CE marking when they are marketed in Iceland. Although custom-made devices are exempt from carrying the CE marking they must conform to all the relevant essential requirements of the Directives. It is not permitted to put a marking or imprint on a medical device that is similar to or can be confused with the CE marking.
The CE marking must be visible, readable and indelible when located on the medical devices or on the sterilized packages where applicable. The same applies to CE markings on instructions and sales packaging.
The manufacturer of a medical device or an authorized representative within the European Economic Area (EEA) is responsible for the CE marking that is put on the product. Manufacturers outside the EEA must have a legal representative within the EEA.
A medical device cannot be marketed in Iceland unless the required information about the manufacturer and instructions on safe and effective use are included with the device. The instructions should either be on the device itself or included in its packages.
The information included with the medical device must comply with all the relevant requirements of the directives and also include the name of the supplier responsible for distributing the medical device in the country. Medical devices that patients themselves must operate should include the required instructions and labelling in Icelandic. This requirement does not apply to medical devices operated by healthcare professionals but should take into account their education and training.
Medical devices that do not fulfil the relevant requirements of the directives and national requirements cannot be marketed in Iceland. Once a medical device is deemed to meet all the requirements it needs to be classified and then the manufacturers must to follow the appropriate conformity assessment procedure. This may require them to have their quality systems and technical documentation reviewed by a notified body before placing their products on the market.
Inquiries and announcements regarding medical devices should be sent to laekningataeki at lyfjastofnun.is.
The Icelandic Medicines Agency (IMA) is the competent authority (CA) for medical devices in Iceland from the May 1st 2011.