Marking of Medical Devices

One of the manufacturing processes during which information regarding the safe use of the device and the conformity mark with technical regulations is applied to the products.

The labeling can be applied either as an additional label to an existing one (e.g., during the recognition procedure) or as a separate layout provided by the manufacturer.

The label on a medical device must include the following elements:

1. The name or trademark and the location of the manufacturer. For imported medical devices intended for circulation, the label, external packaging, or instructions for use must also indicate the name and location of the authorized representative if the manufacturer is not a resident of Ukraine.

2. Information necessary for the identification of the medical device, as well as the contents of the packaging.

3. If applicable – the word “Sterile.”

4. If applicable – the batch code (preceded by the word “Batch”) or serial number.

5. If applicable – the expiry date ensuring safe use of the medical device, specifying the year and month.

6. If applicable – a mark indicating that the device is for single use. The manufacturer’s mark for single use must comply with harmonized standards.

7. For custom-made medical devices – the words “medical device made to order.”

8. For medical devices intended for clinical trials – the words “for clinical trials only.”

9. Information about any special storage and/or usage conditions.

10. Information about any special operating instructions.

11. Information about any precautions and/or warnings.

12. The year of manufacture – for active medical devices not covered by point 5. This information may be included in the batch number or serial number.

13. If applicable – information about the method of sterilization.

14. If the medical device contains human blood derivatives as an integral part – the appropriate indication that the device contains human blood derivatives.