Icelandic Regulation on Instructions for Use Accompanying Medical Devices No. 630/2022

1. Purpose

The regulation governs the provision and presentation of instructions for use (IFU) accompanying medical devices to ensure users are informed about intended purpose, proper use, and precautions. It emphasizes accessibility, clarity, and language compliance for devices marketed in Iceland, while allowing electronic formats under specific conditions to facilitate use by professionals and, in some cases, the public. https://island.is/reglugerdir/nr/0630-2022

2. Definitions

• General public: Patients and individuals using devices for self-treatment or diagnosis (excluding healthcare professionals as defined in Act No. 34/2012 on healthcare professionals).
• Professionals: Individuals using devices within the framework of professional healthcare services.
• Fixed installed medical device: Devices and accessories installed or fixed in place at healthcare facilities, not portable without tools, and not intended for mobile use.
• Label: Written, printed, or pictorial information on the device, its unit packaging, or multi-device packaging (per Article 4, paragraph 21 of Act No. 132/2020 on medical devices).
• Instructions for use: Information provided by the manufacturer to inform users about intended purpose, proper use, and precautions (per Article 23, paragraph 4 of Act No. 132/2020).
• Electronic instructions for use: IFU displayed electronically by the device, on portable storage media provided with the device, or accessible via software or website. https://island.is/reglugerdir/nr/0630-2022

3. Obligations for Operators

Manufacturers must ensure IFU are provided in accessible formats, with non-removable, legible, and comprehensible label information. Importers must verify compliance with IFU requirements before offering devices on the market. https://island.is/reglugerdir/nr/0630-2022

4. Conformity Assessment

Not directly detailed; references compliance with Regulation (EU) 2017/745, which includes conformity assessment procedures for medical devices. https://island.is/reglugerdir/nr/0630-2022

5. Registration

Not explicitly addressed in the regulation. https://island.is/reglugerdir/nr/0630-2022

6. Clinical Investigations

Not mentioned. https://island.is/reglugerdir/nr/0630-2022

7. Vigilance

Not directly covered; oversight and penalties refer to Chapter VII of Act No. 132/2020 on medical devices. https://island.is/reglugerdir/nr/0630-2022

8. Market Surveillance

Oversight of this regulation and violations is governed by Chapter VII of Act No. 132/2020 on medical devices. https://island.is/reglugerdir/nr/0630-2022

9. Language Requirements

For devices intended for general public use, IFU must be in Icelandic, except for risk class I and IIa devices, which may use English or other Nordic languages (excluding Finnish). The Icelandic Medicines Agency may publish lists exempting certain class IIb and III devices from Icelandic IFU requirements, but English or other Nordic languages must still be provided. Language requirements apply to electronic IFU. https://island.is/reglugerdir/nr/0630-2022

10. Electronic Instructions

Manufacturers offering electronic IFU must conduct risk assessments per Commission Implementing Regulation (EU) 2021/2226 and provide paper IFU free of charge within specified periods (up to seven days) upon request. Information must comply with Annex I, Chapter III, Section 23 of Regulation (EU) 2017/745. https://island.is/reglugerdir/nr/0630-2022

11. Penalties

Violations are handled under Chapter VII of Act No. 132/2020 on medical devices (no specific penalties detailed here). https://island.is/reglugerdir/nr/0630-2022