Patient information management (IFU, Labelling and Cartons)
A ‘Label’ is the identity of the product. It is through the label and contents of the label that an end user identifies the product and could be the first point of information. Different regulations enlist various requirements for labelling. Our experts can support this entire process and ensure that your product/innovation has the correct label with all required information.
Many manufacturers ask our experts –
What are the labelling requirements for medical devices?
As we all know, the label represents the printed, written, and graphic information that appears on the medical device itself or its packaging. To avoid problems, manufacturers must ensure their product labels contain the following elements:
- Product name
- Product’s lot number or serial number
- All details needed for a user to identify the device, the contents of its packaging and the intended purpose of the device
- Contact details of the manufacturer
- In the case of non-EU based manufacturers, the name and address of their authorised representative
- The UDI carrier referred to in Part C of Annex VII of the EU MDR (2017/745)
- An indication of any special storage or handling conditions
- A clear indication of the time limit for using the device safely, or where this is not applicable – the date of manufacture
- If the product is supplied in a sterile condition, an indication of its sterile state and method of sterilisation
- An indication if the product is for single use
- An indication if the device is custom-made or intended for clinical investigation only
- Other warnings and precautions to be taken that need to be brought to the user’s immediate attention
Why is this label a big deal?
Well, a small error on the label can lead to a product recall. Protect your product with the correct labelling practices designed by our experts!
Apart from labelling, manufacturers also need to comply with IFU requirements.
What is IFU?
IFU stands for “Instructions for Use” and every medical device must have one and it must be accessible to the end-users of the product.
Medical device manufacturers must comply with several requirements regarding the information provided with their devices. Each medical device must be accompanied by the information required to identify the device and its manufacturer and any safety and performance information relevant to the user.
Any misprint, misinformation or missing element can lead to a product recall.
Our experts provide you with comprehensive labelling, IFU and other regulatory affairs solutions.
Contact us for a FREE 30 Minute Consultation by dropping an email at firstname.lastname@example.org
Med-Di-Dia – Your Regulatory Risk Partners for Medical Devices, Diagnostics and Digital Health!