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February 11, 2026
Approximately 5 minutes
Icelandic Regulation on Reprocessing of Single-Use Medical Devices No. 1154/2021
Icelandic Regulation on Reprocessing of Single-Use Medical Devices No. 1154/2021
1. Purpose
The regulation stipulates the reprocessing of single-use medical devices to ensure safety and functionality equivalent to the original device, emphasizing processes such as cleaning, disinfection, and testing.
2. Scope
The regulation applies to the reprocessing of single-use medical devices, including within healthcare institutions and by external reprocessors.
3. Definitions
- Single-use device: Device intended for use on one patient during one procedure (cf. item 8 of paragraph 1 of Article 4 of Act No. 132/2020).
- Reprocessing: Process for reuse of a device safely, including cleaning, disinfection, sterilization, testing, and restoration of safety (cf. item 9 of paragraph 1 of Article 4 of Act No. 132/2020).
- Reprocessor: Healthcare institution or external entity reprocessing single-use devices (cf. item 1 of Article 2 of Implementing Regulation (EU) 2020/1207).
- Reprocessing cycle: Cycle of all reprocessing phases to ensure safety and functionality (cf. item 2 of Article 2 of Implementing Regulation (EU) 2020/1207).
- Manufacturer's specification: Instructions for maintenance and repairs in the device manual (cf. item 11 of paragraph 1 of Article 4 of Act No. 132/2020).
- External reprocessor: Entity reprocessing devices at the request of a healthcare institution (cf. item 3 of Article 2 of Implementing Regulation (EU) 2020/1207). https://island.is/reglugerdir/nr/1154-2021
4. Obligations
Reprocessing must comply with common specifications in Implementing Regulation (EU) 2020/1207. Reprocessing ensures equivalent safety and functionality. Reprocessing falls under manufacturer obligations according to Regulation (EU) 2017/745, with exemptions from Implementing Regulation (EU) 2020/1207. https://island.is/reglugerdir/nr/1154-2021
5. Conformity Assessment
Reprocessing and reuse must follow common specifications in Implementing Regulation (EU) 2020/1207 to ensure safety and functionality. https://island.is/reglugerdir/nr/1154-2021
6. Registration
No specific provisions on registration in the regulation. https://island.is/reglugerdir/nr/1154-2021
7. Clinical Investigations
No specific provisions on clinical investigations in the regulation. https://island.is/reglugerdir/nr/1154-2021
8. Vigilance
The reprocessing cycle must ensure equivalent safety and functionality, with testing on technical and usage safety. https://island.is/reglugerdir/nr/1154-2021
9. Market Surveillance
The Icelandic Medicines Agency acts as the competent authority according to Implementing Regulation (EU) 2020/1207. Surveillance and penalties proceed according to Chapter VII of Act No. 132/2020 on medical devices. https://island.is/reglugerdir/nr/1154-2021
10. Language Requirements
No specific provisions on language requirements in the regulation. https://island.is/reglugerdir/nr/1154-2021
11. Penalties
Violations against the regulation are subject to surveillance and penalties in Act No. 132/2020, Chapter VII. https://island.is/reglugerdir/nr/1154-2021
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