Medical device labelling
Medical device manufacturers obligations
Manufacturers of medical devices are responsible for all aspects of the device, including the design, production, packaging and labelling such as instructions of use. With differing regulatory and compliance requirements globally, manufacturers must work to meet specific product, labelling and safety needs.
Medical device labelling includes the written content or graphics accompanying or attached to a medical device. This also includes any of the device's containers and wrappers. This labelling provides important information related to the identification of the device or product, any technical descriptions or instructions.
With differing requirements between regions, the list of labelling requirements may include, but aren't limited to:
General information of the manufacturer, such as the name and address of where the device was produced.
Safety information can include warnings that could relate to the device, whether the product was custom-made and should only be used for the intended patient, etc.
Product information can include specific handling and storage requirements, the intended purpose and user of the device, operating instructions, inclusions of methods used to sterilise the device (if applicable), if the device is only single use, batch code or serial number, any expiry dates, etc.
Medical Device Labelling Standards
The international Standard ISO 15223 series sets out recommended practices for symbols to be used with medical device labels, labelling and other information to be supplied with the medical device. This is a two-part series, including:
Part 1: General Requirements
ISO 15223-1:2016 specifies the requirements for symbols used for medical device labelling. Its purpose is to state the essential information needed to use the device safely and efficiently. This Standard also includes symbols that meet the requirements stated within the document and can be applied to a wide range of medical devices.
Part 2: Symbol development, selection and validation
ISO 15223-2:2010(R2016) sets out the process for developing, selecting and validating symbols for inclusion in ISO 15223-1, where this Standard helps ensure the symbols are easily understood by the intended target groups.
Medical Device Labelling across the globe
As medical device labelling requirements can differ greatly between countries and regions, deciding where a product or device will be marketed and sold is essential throughout the earlier stages of development. This can help avoid different labels for each market where all inclusions can be made onto the single label, while still meeting set requirements for general, product & safety information.
European labelling requirements
As the new EU Medical Device Regulations (MDR) are set to switch in May 2021, labelling requirements are due to become stricter to improve product safety. The MDR changes will require medical device manufacturers to supply and document more information to meet the new compliance measures.
American labelling requirements
The U.S. Food & Drug Administration (FDA) develops and sets the labelling requirements for all medical devices used in America. The FDA state that medical device labelling must meet the Good Manufacturing Practice (GMP) requirements.
Australian labelling requirements
The Therapeutic Goods Administration as part of the Australian Government Department of Health handle Australian regulatory guidelines for medical devices. They state that all medical devices developed and sold in Australia need to meet the Essential Principles requirements for labelling and instructions.
Standards play a crucial role in guiding labelling requirements within the medical device industry. They assist with improving development & production efficiencies, meeting compliance needs and ensuring the correct product & safety information is included.
Understanding ISO 14971:2019
The medical device risk management Standard
The third edition of ISO 14971:2019 was published in December 2019 and provides a thorough process for manufacturers within the medical device industry to assess, monitor, and control risks in the creation and use of a medical device.
Medical Devices Regulatory Obligations
Staying compliant in the medical device industry
Continuing to meet your regulatory obligations means ensuring that your organisation is always using up-to-date and current Standards. i2i can help those in the MedDev space to stay compliant past the short-term focus on the EU MDR 2021 deadline.
Standards for Face Masks
Personal protective equipment (PPE) Standards
Standards play an important role in determining the effectiveness of personal protective equipment (PPE). PPE includes clothing and other equipment with the intention to protect someone from risks of injury or illness.