In a tweet dated January 16, 2024, we presented the "Key Points in the Process of Applying for CE Marking for In Vitro Diagnostic Products", and in this section of preparation of technical documents, we describe the main structure of technical documents. In a tweet on March 1, 2024, we introduced how the first part of the IVDR technical document should be prepared, and in this article we continue with the second part: a complete set of labels and instructions.
According to Section 2 of the Technical Documentation of Annex II of the IVDR Regulation, the technical documentation shall contain:
01
Tags (IVDR Appendix I, 20.1, 20.2, 20.3)
1. Classification of labels
1) There are many types of IVD products, and when preparing the technical documents, the labels related to the products need to be provided to the notified body for review.
Common labels usually include: minimum package labels, sales package labels, shipping package labels, sterile packaging labels, etc.
Example:
Solid-phase reagent IVD (colloidal gold/fluorescent immunochromatography): aluminum foil bag, bag sticker, kit, box sticker
*Note that the foil pouch itself and the box itself are also labels, and their design should be provided together
Liquid reagents, IVDs (chemiluminescence reagents, biochemical reagents, etc.): reagent bottle stickers, calibration quality control bottle stickers, kits, box stickers
2) When submitting the technical documents, in order to facilitate understanding, the Notified Body recommends that the manufacturer provide a draft of the packaging design (where all labels can be displayed) and the specifications of the labels (layout dimensions, etc.)
Examples: Box design and label design
2. Requirements for the content of the label
When preparing the IVDR technical file, the manufacturer should prepare the label content according to the category and characteristics of the product and according to the requirements of the following standards.
02
说明书(IVDR 附录I 20.1 20.4)
When preparing the instructions for IVD products, it is necessary to comply with the relevant requirements of Annex I 20.1 and 20.4 of the IVDR, and prepare them against the requirements of the relevant standards in the above table. At the same time, special attention should be paid to the following:
1. It is necessary to ensure that the contents of the specification are consistent with those in other technical documents, in particular the product name, intended use, restrictions and other safety-related information (e.g. safety and warnings) and other relevant information in the technical documents (e.g. risk management, performance evaluation, usability, etc.)
2. It is necessary to ensure that the relevant standards or general specifications are applied in the specifications (e.g. ISO 18113 series standards, EN60601 series standards, ISO 15223-1, etc.)
3. The language version of the specification must be determined in accordance with the requirements of IVDR 10(10) and the target market, with at least an English version of the specification required for initial submission.
4. The results of the performance indicators listed in the specification should be supported by the corresponding technical documents, for example, the results of the interference study should be correlated with the research data in the technical documents.
5. CE marking is required as required by Annex V of the IVDR. Special care should be taken to avoid the following common mistakes.
mistake
That's right
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