Hi friends!!!
In our previous blog, we have discussed about the following topics.
EU MDR Timeline, Annex, Chapter
EU MDR Post Market Surveillance
EU MDR Technical Documentation - Part 1
EU MDR Technical Documentation - Part 2
EU MDR General Safety and Performance Requirement
EU MDR 2017/745 is live now. And it the most trending topic in Medical Device Regulatory Affairs field. Most of the medical device companies are in EU MDR Transition to make sure that they can sell their products in Europe.
Therefore, it is important for Medical Device QA/RA Professionals to know in detail about EU MDR 2017/745 requirements for Information on the Label.
Let’s discuss in detail about the Information to be present on the Label as per EU MDR 2017/745.
INFORMATION ON THE LABEL
In EU MDR 2017/745, Annex 1, Chapter III, Section 23.2 talks about the requirements for Information on the Label.
The label shall bear all
of the following particulars:
1. The name or trade name of the device.
2. The details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device.
3. The name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business.
4. If the manufacturer has its registered place of business outside the Union, the name of the authorized representative and address of the registered place of business of the authorized representative.
5. Where applicable, an indication that the device contains or incorporates: — a medicinal substance, including a human blood or plasma derivative, or — tissues or cells, or their derivatives, of human origin, or — tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012.
6. where applicable, information labelled in accordance with Section 10.4.5.
7. The lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, as appropriate.
8. The UDI carrier referred to in Article 27(4) and Part C of Annex VII.
9. An unambiguous indication of the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant.
10. Where there is no indication of the date until when it may be used safely, the date of manufacture. This date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable.
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11. An indication of any special storage and/or handling condition that applies.
12. If the device is supplied sterile, an indication of its sterile state and the sterilization method.
13. Warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users.
14. If the device is intended for single use, an indication of that fact. A manufacturer's indication of single use shall be consistent across the Union.
15. If the device is a single-use device that has been reprocessed, an indication of that fact, the number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles.
16. If the device is custom-made, the words ‘custom-made device.
17. An indication that the device is a medical device. If the device is intended for clinical investigation only, the words ‘exclusively for clinical investigation.
18. In the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, the overall qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action.
19. For active implantable
devices, the serial number, and for other implantable devices, the serial
number or the lot number.
Now I hope you have acquired some knowledge about EU MDR 2017/745 requirements for Information on the Label. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.
NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.
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