In the plastic manufacturing industry, we must be aware that health products and plastic packaging for the pharmaceutical sector are of special care, since it is in a continuous state of progress and change in processes.
That is why Triana, a pioneer in this sector with more than 50 years of experience, has adapted to the new reality for conformity labeling and the new European directives for medical devices (MDR) are a letter of presentation of quality in their production processes.
In this post we are going to explain what it consists of and its importance, to understand what requirements a manufacturer of these devices must have.
What are MDRs?
The acronym MDR refers to the term Medical Device Regulation, these products have a special requirement regarding their manufacturing regulation and they have been affected by the new regulations that have come into force.
From May 26, 2021, the new EU regulation, the Medical Device Regulation (MDR) 2017/745, will replace the existing regulation until now.
Within these modifications in manufacturing, special attention will be paid to the determining aspects of the labeling of these products, and we must bear in mind that MDRs are effects of special care and treatment in their labeling, since we are dealing with the manufacture of medical products. that influence the life and well-being of people.
The importance of Labeling in MDRs and its adaptation to the new European measures.
Now the manufacturers of these products, in addition to meeting the various requirements that are demanded by the new regulation, must provide in their manufacture all the necessary information that identifies the manufacturer, and all the safety, performance and production process procedures that are relevant to follow the traceability of the product in a clear and orderly manner.
The labeling will also have a series of specifications on which the manufacturer echoes regarding the implementation of this information in the product, being able to find it in the surface areas, on the packaging or in the leaflets or instructions for use that accompany the MDR produced.
LABEL requirements for MDR products for adaptation to new EU guidelines
Labels that comply with the new regulation of Medical Devices Regulation 2017/745 must include the following information:
- Product nomenclature
- Clear specification of the batch or serial number that identifies the product.
- Detail of the device, packaging, and its purpose.
- Information about the manufacturer and his contact, and companies that are located outside the EU must provide the information of the marketing company or authorized representative in European territory.
- Follow the requirements in terms of labeling specifications of the chemical, physical and biological properties of the materials, attending in this point to their labeling specifications specified in point 10 of ANNEX I – General safety and performance requirements.
- Identify the UDI carrier mentioned in part C of Annex VII of the MDR.
- Specify clearly and without any doubt the deadlines for using the device or if it is not relevant to report the date of manufacture.
- Indicate if the product is for single use clearly, as well as if it is a product specially manufactured for research or has been made to measure.
- Storage, indicate any element that may be affected by its handling.
- Sterilization: for those MDIs that are transported, supplied, or presented in sterile format, it must be indicated which sterilization method has been used, the process and the state of sterilization, if applicable.
- Any rule of use or precaution that must be observed or that has special attention for the user should be noted on the label.
Only those companies capable of being certified and complying with the labeling requirements, as well as the correct completion of the user manuals, will be qualified to produce MDR and will be able to be marketed in the territory of the EU.
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