ZVA MinistruMinistru kabineta noteikumi Nr. 582
Ministru kabineta noteikumi Nr. 582 is the official ZVA identifier for “In vitro diagnostikas medicīnisko ierīču noteikumi (In Vitro Diagnostic Medical Device Regulations)”. Ministru kabineta noteikumi Nr. 582 is the official identifier ZVA uses for this instrument.
- Instrument
- Ministru
- Full name
- Ministru kabineta noteikumi Nr. 582
- Category
- Registration
- Authority source
- Latvian
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- 0 articles · 1 language version
- Published
- October 12, 2023
- Effective
- October 13, 2023
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In vitro diagnostikas medicīnisko ierīču noteikumi (In Vitro Diagnostic Medical Device Regulations)
Ministru kabineta 2023. gada 10. oktobra noteikumi Nr. 582, adopted 10 October 2023, in force since 13 October 2023, published in Latvijas Vēstnesis 198 of 12 October 2023. The IVD counterpart to Regulation No. 461 and issued under the same two authorising provisions — Article 34(2), points 2, 3, 4 and 5 of the Medical Treatment Law and Article 7(1) and (2) of the Conformity Assessment Law. In eight chapters: general provisions; the notification procedure for in vitro diagnostic medical devices; the rights and duties of State administrative institutions; the procedure for entering information on IVD manufacturers, their devices and distributors into LATMED; authorisation to place an IVD on the market; distribution, use and operation; accidents and the vigilance system; and concluding provisions — with three annexes: the notification form to the Zāļu valsts aģentūra, the incident signal report for health-care institutions, and the report for a person who uses a device independently or on a health-care practitioner’s instruction. Consolidated gazette text, currently in force.
Ministru kabineta noteikumi Nr. 582 is the official identifier ZVA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.