Annex II: Technical Documentation Format

1.   Device Description And Specification, Including Variants And Accessories

2.   Information To Be Supplied By The Manufacturer

3.   Design And Manufacturing Information

4.   General Safety And Performance Requirements

5.   Benefit-Risk Analysis And Risk Management

6.   Product Verification And Validation

Medical devices instructions for use intended for use by healthcare professionals may be published in English, or a Nordic language other than Finnish.

The general rule is that instructions for use intended for the general public shall be in Icelandic.

The Clinical Trials Information System (CTIS) supports the flow between clinical trial sponsors, European Union (EU) Member States, European Economic Area (EEA) contries and the European Commission.

MDCG 2023-4: Medical Device Software (MDSW)

The IMA may charge fees for the following:
1. The issue of certificates (cf. point 1 of paragraph 6 of Article 6).
2. Monitoring the use of medical devices (cf. Article 16).
3. Monitoring of maintenance of medical devices (cf. Article 17).
4. Assessment of applications for clinical investigation on medical devices (cf. paragraph 3 of Article 20).
5. Registration of distributors (cf. paragraph 3 of Article 28).
6. Monitoring of economic operators of medical devices (cf. Article 34)

Chapter V, Article 60: The certificate of free sale shall set out the Basic UDI-DI of the device as provided to the UDI database under Article 29. Where a notified body has issued a certificate pursuant to Article 56, the certificate of free sale shall set out the unique number identifying the certificate issued by the notified body, as referred to in Section 3 of Chapter II of Annex XII.

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.

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 circumstanc

Medical devices may be advertised in Iceland, subject to the restrictions laid down in the Regulations and in this Act.
Advertisements shall at all times be presented in an objective manner and shall give satisfactory information about the device, its properties and its use. The user or patient shall be informed of potential
risks involved in the use of the device in line with its intended purpose.

Manufacturers of medical devices, importers and authorized representatives must, according to the regulation on medical devices, register in Eudamed. According to the Icelandic law on medical devices, distributors of medical devices who are responsible for the marketing of such devices in Iceland must register with The Icelandic Medicines Agency, IMA.