Labeling is not just a simple piece of paper with dumping information, usually people will be least bothered to read it and sometimes tear it off. The term labeling has lot of importance and when it comes to medical device labeling; it assists patients or their lay caregivers in operation, handling,benefits, risks, as well as maintenance. It also educate in the way interacts with the body to accomplish its purpose; its place and purpose in the patient care regimen; and any safety or disposal issues. Adequate directions for operating the devices are needed to make devices safe and effective. By keeping all such necessities, medical device manufacturers prepare it with utmost care thoughit’s a difficult issue. Labeling is a critical component of the device and provides comprehensive requirements for marking and labeling. The standard requires all information for safe installation, use, storage, servicing, and maintenance of the device to be provided to the user. For safety-significant items and for effective use of the device, the standard requires that markings be placed directly on the device. For instance, a prefilled syringe allowing a patient to administer a measured dose of medication at home could help treat or prevent a specific disease when used correctly. If used incorrectly, a number of adverse effects may occur, such as injury from improper handling of the needle or an incomplete dose of medication. To avoid such scenarios, it’s good to follow some Do’s and Don’ts of medical device labeling.
It is better to understand different regulations that need to be followed before creating medical device label and releasing to the general public. Manufacturer should identify if the medical device is being used by a qualified medical technicians or as a home use device.The label contents differ depending on the end users.Medical device labels include information provided with the device and some of these include warnings, symbols, installation instructions, user manuals, point of sale displays, UDI and maintenance instructions. Most of the jurisdictions follow medical device labeling, and three common jurisdictions relevant requirements are:
- Canada: Guidance for the Labeling of Medical Devices
- EU: EU Medical Device Regulation (MDR) 2017/745
- USA: FDA CFR 21 Part 801
Additionally electrical medical devices have labeling requirements defined in IEC 60601-1 clause 7. Though there is minor alteration in jurisdiction requirements in locations, global instructions have following do’s and don’ts in creating medical labels.
- Include contact information for the device manufacturer or the distributor. In case if the medical device is not manufactured in the country, provide contact information for the local representative.
- The label should identify the device contents, model number, batch/serial number and date of manufacture.
- Label should indicate the intended use of the device and state if any contra indications are required to follow.
- The label should also state all possible side effects that can be experienced from the use of the device.
- Ensure that the label is listed with all the contents to be found in the packaging box.
- Ensure that the label contains general warnings and precautions such as hazards associated with the use or disposal of the device, any risks to the environment or society from the disposal of equipment and its accessories.
- Clear instructions on how to correctly handle and use the device.
- Cautions and warnings should be clearly stated which may result from the risk management process.
- Materials used for labeling should remain legible during the entire lifespan of the device and should be able to withstand cleaning fluids to be used on the device.
- Make certain that the label uses symbols required by the law. See ISO 15223 and 60878 for symbols. Devices sold in the USA require explanatory notes with the symbols.
- The label can also add first aid procedures that can be undertaken in case one sustains an injury in the process of using the device.
- Senior research expert should review the labeling before the device is submitting for clearance.
- Do not make statements on the label which contradicts the intended use or that have not been approved, supported by data.
- Do not include any marketing statements or text to show that the device has been approved by a certain government body.
- Do not refer to any ISO certification number if your device has not been permitted by the registrar.
- Don’t include any text stating or implying Health Canada, FDA approval or endorsement of the device.
- Do not make any changes on the contents of a label once it is cleared by the regulatory.
- Without any written permission do not use the certifying body (e.g. CSA, ETL, UL) artwork on the product label.
As a final thought, manufacturers of medical devices are advised to plan their label designs in device design planning. This helps manufacturer to make changes when it need to be and not necessary to wait until last minute to design labels. Also make sure that a thorough research on the regulations has been done before submitting medical label for clearance.