Medical device labelling is essential for conveying vital information related to the medical device. The labels guide users, thereby play a pivotal role in patient safety. Medical devices are one of the pillars of the healthcare industry. Regulatory guidelines are in place to monitor the quality, efficacy, and safety of the devices. Medical device labelling is one of the guidelines which the regulatory body uses to ensure regulatory compliance and healthcare efficacy. CDSCO, the apex regulatory body in India, functions under the purview of Medical Devices Rules, 2017 (MDR). The MDR has outlined the labelling requirements for medical devices in India. The MDR medical device labelling requirements ensure proper usage, facilitate effective healthcare delivery, and enhance patient safety. This blog will shed light on medical device labelling requirements in India.

Essential parameters of MDR labelling requirements for medical devices

Medical device manufacturers need to provide labels that are informative and universally recognizable, thereby contribute to improved patient outcomes. MDR medical device labelling requirements regulate the labelling of medical devices intended for Indian market. The following factors form the basis of medical device labelling requirements in India:

1. Information on intended use: User friendly information to help users identify the device and understand its intended use.
2. Identifying information: The device’s name, batch number, or serial number for identification need to be presented clearly.
3. Manufacturer/Importer details: Manufacturer’s/Importer’s name, address, and manufacturing facility details.
4. Manufacturing/Import license number: The manufacturing/import license number for the medical device needs to be mentioned.
5. Quantity and Metrics: Net quantity should be mentioned using the metric system. The volume, weight, or unit should be mentioned as applicable.
6. Batch or lot number: For traceability, batch or lot number should be distinctly indicated.
7. Manufacturing and expiry date: Information on month and year of manufacture and shelf life or expiry date needs to be mentioned.
8. Sterile state and sterilization method: The device’s sterile state and sterilization method need to be indicated.
9. Sterilization information and details: For sterile devices, sterilization date and recommended shelf life should be mentioned.
10. Special storage conditions: Special storage or handling conditions need to be indicated.
11. Medicinal or biological substance: If the device contains medicinal or biological substance, the medical device label should clearly state the same.
12. Single-use indication: For devices intended for single use, this should be clearly specified on the label.
13. Warnings: Any specific warning the user should be cautioned about.
14. Free sample indication: If the device is a free sample to be provided to healthcare professionals, then this should be clearly specified.
15. Clinical evaluation medical devices: Medical devices manufactured for clinical investigation, testing, evaluation, or training purposes must have labels indicating the same. The product’s name, batch or lot number, manufacturing and expiry date, and storage conditions should be specified on the medical device label. Additionally, manufacturer’s details and information should be mentioned.

MDR medical device labelling requirements have been prepared keeping in mind the role medical devices play in the healthcare sector. Clear and easily understandable medical device labelling will help both healthcare professionals and patients. MDR medical device labelling requirements facilitate easy comprehension of intended use and communication of vital information associated with the device.

The need for labelling requirements for medical devices

Medical devices are used to diagnose, monitor, and treat patients. Thus, proper identification, correct usage, and patient safety are vital for effective healthcare delivery using the medical device.  Medical device labelling conveys device related information to patients and healthcare professionals. Medical device labelling improves user understanding, effective use of the device, and patient safety. Labelling requirements for medical devices provide guidelines to manufacturers on how to properly label their products. The guidelines are focused on patient safety and effective and efficient healthcare delivery.

Labelling requirements for medical devices facilitate effective communication between manufacturers and patients and healthcare providers. Medical device labelling conveys critical information about the device, such as its purpose, usage instructions, any warnings, and manufacturer details. Labelling requirements for medical devices ensure accurate and comprehensive medical device labelling. The primary goal of medical device labelling is proper identification, handling, and administration of medical devices. Additionally, proper medical device labelling demonstrates the manufacturer’s commitment to improved patient outcome and safety.

MDR medical device labelling requirements ensure proper labelling of medical devices before they enter the Indian market. Specific guidelines have been provided for manufacturers to help them with the medical device labelling requirements in India. The MDR medical device labelling requirements are aimed at protecting the public health and safeguarding the Indian healthcare sector.

MDR medical device labelling requirements

Medical device labelling requirements in India are governed by MDR. Prior to marketing medical devices in India, proper labelling according to MDR labelling requirements for medical devices is mandatory. The labelling has to be done using indelible ink. The labelling should be present on the label and shelf pack or on the outer cover of the medical device. Additionally, the label should be present on the outer covering in which the medical device is packed.

The guidelines also state that “Instructions for Use” should be provided in addition to the medical device label. Per MDR medical device labelling requirements, symbols accepted by the Bureau of Indian Standards (BIS) or International Organisation for Standardisation (ISO) may be used instead of text. However, the manufacturer should bear in mind that use of symbols should not compromise device safety. Not all symbols will be easily understood by users. Hence, manufacturers should avoid using symbols that may not be easily clear to users.

MDR labelling requirements for medical devices need the following details to be printed on the label:

• The name of the device
• Details of the medical device and its intended use
• Manufacturer’s details (name and address)
• Manufacturing licence number preceded by the words “Manufacturing Licence Number” or “Mfg. Lic. No.” or “M. L” for devices manufactured in India and “Import License number” or “Imp. Lic. No.” or “I. L” for devices imported into India.
• For imported devices: In case the import licence number, name and address of the importer, address of the actual manufacturing facility, and the date of manufacture are not clearly printed on the product, the details should be added with the help of stickers.
• Net quantity and number:  The volume, weight, and number of units should be mentioned. The quantity should be expressed in the metric system.
• Manufacturing and expiry (or shell life) month and year. In case of sterile products, the date of sterilization should be mentioned.
• If the device contains medicinal or biological substance, it should be clearly mentioned.
• Batch or lot number with the term “Lot No.” or “Lot” or “Batch No.” or “B. No.” preceding it should be mentioned.
• In case of sterile products, the sterilisation method and state should be specified.
• Any necessary special storage or handling requirements should be mentioned.
• A device intended for single use should be clearly specified on the label.
• Any warning or precaution needed should be clearly mentioned.
• For devices intended as samples, “Physician’s Sample—Not to be sold” should be clearly mentioned on the label.

Companies planning to launch their product in India need to pay close attention to medical device labelling requirements in India. Proper medical device labelling shows the manufacturer’s commitment to patient safety and regulatory compliance. Labelling requirements for medical devices are aimed at helping patients and healthcare professionals take informed decision. Thus, compliance with this regulatory requirement is mandatory. For all your medical device regulatory needs, Pharmadocx Consultants is your go to partner.