ISO 13485 Certification in Oman According to the definitions in the European Union’s then the Medical Device Regulation, “label” means any written, printed, or graphic information will be appearing either on the both device itself, or on the packaging of each unit or on the packaging of multiple devices. The purpose of the labelling process is to identify a medical device and its manufacturer, and to communicate with essential information on safety, use, and performance. It is intended for users of medical devices, both professionals and consumers, and for relevant third parties.
ISO 13485 Consultant Services in Oman Although we all are aware, the MDR brings many challenges for medical device manufacturers. One of them is labelling, with new requirements that ask for many kinds of information to be indicated on the labels of medical devices.
Labelling the requirement under the new MDR
ISO 13485 Consultant in Oman Compared to the MDD 93/42/EEC, there is a need given for much more information on the labels under the EU MDR, because of the certain device safety and clinical effectiveness data is required to be shared transparently with all our users (both medical staff and patients or end users). All requirements regarding the information have been supplied with the medical devices are covered in Chapter III of Annex I, General safety and performance requirements, in EU MDR.
How to get ISO 13485 Certification in Oman There are two possible problems which they are trying to comply with the EU MDR labelling with all requirements. One of our all necessary symbols and information has been covered. The other one is the size of the label. As there will be many more symbols and data has been required, the big challenge for everyone is being how to fit it all on the label. During label design, keep the following thing in mind that the medium, format, content, legibility, and location of the label and its instructions must match up with the technical knowledge, experience, education, or training of the intended user(s). Furthermore, instructions for use must be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.
EU MDR CHECKLIST OF MANDATORY DOCUMENTS
1) UDI number. So far, under the MDD, it was mandatory to include a lot number and/or a serial number on the label. The EU MDR introduces the term “UDI number,” which may requires much more space on the label. Besides that, every active implantable device must have its own unique serial number, while other implantable devices will require a serial or lot number.
2) Warnings and Precautions. There is a request in Chapter III of Annex I, section 23.2, that all the warnings relating to a device must be printed on the label. However, it is also stated that this information can be kept to a minimum, in which case more detailed information shall appear in the instructions for use, taking into account the intended users. The choice of which warnings need to be included is left to the manufacturer, but the best way is to use those warnings that request immediate attention.
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