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[Postponement] The European Union recently announced the extension of the IVDR transition period. The IVDD certificate is different according to the IVDR classification, and the maximum extension can be until May 25, 2027.
Release time:
2021-11-29
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The specific deadlines for various types of products are as follows: For products (Self-testing, List B, List A) originally issued by the notifying agency, the latest use period is 2025.5.26.
The specific deadlines for various types of products are as follows:
For products (Self-testing, List B, List A) originally issued by the notifying agency, the latest use period is 2025.5.26.
Products classified in the others category under the original IVDD directive, if they are classified as category D in the IVDR, must obtain the IVDR certificate by 2025.5.26 at the latest. Such as COVID-19 diagnostic reagents.
Products classified in the others category under the original IVDD directive, if they are classified as category C in the IVDR, must obtain the IVDR certificate by 2026.5.26 at the latest. Such as genetic screening, tumor screening, etc.
Products classified in the category of others under the original IVDD directive, if they are classified as category B in the IVDR, must obtain the IVDR certificate by 2027.5.26 at the latest. For example, influenza virus, etc.
For products classified as others under the original IVDD directive, if they are classified as Class A sterilization in the IVDR, they must obtain the IVDR certificate by 2027.5.26 at the latest.
The classification as Class A under the IVDR is not in the extended scope, and it still needs to meet the requirements of (EU) 2017/746 with Self-declaration on May 26, 2022.
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