Understanding updates on medical device labelling
As new regulatory requirements demand understanding and action from global manufacturers, the healthcare sector seeks to foster collaboration and explore consistency throughout global supply chains. By Natasha Spencer-Jolliffe.
M edical device labels aim to inform patients and healthcare providers, on how to use and maintain instruments, as well as communicating safety or associated risks.
As device and diagnostic manufacturers worldwide develop new products to improve patients’ quality of life, labels and instructions-for-use (IFUs) are becoming essential in developing trust between healthcare practitioners and providing consumer confidence.
Quality and compliance are continuing priorities in medical device labelling as the industry looks to adopt new procedures and systems to ensure standardisation, consistency, and reliability.
Labels protected under law
In Europe, the EU Medical Devices Regulation has been applicable in EU Member States and Northern Ireland since 26th May 2021 and the In Vitro Diagnostic Medical Devices Regulation since 26th May 2022. Rather than substantial changes to the regulation, updates refer to transitional provisions allowing for a progressive rollout.
In the UK, secondary legislation was enacted in January 2021, making several amendments to how devices are placed on the market and introducing a new route to market and product marking, known as the UK Conformity Assessed (UKCA) marking, replacing the CE marking and striving to strengthen the registration process.
To date, medical devices with a UKCA marking have been able to be placed in the UK market. However, as it currently stands, this will only be possible until 30th June 2023. Despite the upcoming expiration date, subject to Parliamentary approval, the UK government intends to introduce measures before 30th June 2023 to ensure CE-marked devices can enter the UK market following specific timelines.
Updates are taking hold in other markets. On 1st March 2023, the Brazilian Health Regulatory Agency (ANVISA) implemented a new medical device regulation RDC 751/2022, which strives to consolidate and align information on classifying risk, labelling and instruction requirements.
Regulations do not mean standardisation
Despite these laws governing medical device labelling, individual countries are asserting requests for variations based on factors such as environmental considerations and updates other markets have implemented.
In Italy, for example, ahead of environmental labelling requirements that came into force on 1st January 2023, the Ministry of Ecological Transition expressed uncertainty over the timeline for adopting environmental labelling requirements for medical equipment packaging.
In addition, updates to EU regulations have had ripple effects beyond the continent. In Malaysia, the Asia-Pacific country’s Medical Device Authority (MDA) published further guidance in November 2022 on medical device labelling and handling of authorised products’ change notifications to progress its labelling direction and reflect EU changes to labelling requirements.
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Even in countries with existing regulatory governance, research recommendations encourage the relevant authorities to revisit and mould medical device labelling to ensure it protects consumers and reduces the risk of harm to consumer health.
In a January 2023 commentary piece in the Nature Medicine journal, researchers stated that the US Food & Drug Administration (FDA) should “address health misinformation through existing and new regulatory approaches, including modernising product labelling, investing in infodemic surveillance and addressing the roles of the internet and social media”.
Also, in findings pertaining to the EU market, researchers highlighted the importance of EU legislation to demand disclosure and labelling of the composition of medical devices after adverse skin reactions were reported following their use. The researchers advocated for complete and accurate ingredient labelling.
Standards and guidance
Standardised rules and guidance, such as the International Organization for Standardisation (ISO) and GS1 Standards, give companies a unified way to individually identify, accurately detail and automatically share information about their products via barcodes and identification keys.
Updated in 2022, ISO 18113-1 covers in vitro diagnostic medical devices, including information supplied by the manufacturer (labelling). Part 1 covers terms, definitions and general requirements, while part 2 focuses on professional use. ISO 15223-1:2016 is specific to medical devices and relates to symbols for labels, labelling and information.
Certain countries, such as China and Japan, have specific standards for their labelling requirements. General standards also govern medical device labelling, namely the FDA's Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labelling and Principles of Labelling for Medical Devices and IVD Medical Devices.
Legislative changes in the medical devices industry mean manufacturers may need to revisit their products, processes, and packaging to meet new regulatory updates. However, these must also continue to optimise operations and create convenient label data collection methods.
One area in medical device labelling that has evolved is e-labelling, with Asia and Australia tipped as the leading markets. Convenience and real-time data insights are key drivers in technological developments. With e-labelling, patients and healthcare practitioners can access information clearly and online or via an app in a customised format to suit the individual’s needs.
Human factors engineering is a growing concept amid the rise of at-home medical devices. With labelling contributing significantly to the safety and overall user experience, efforts to optimise packaging via labels have a captive audience. The healthcare industry anticipates that 2D barcodes with unique serialisation, UV identification codes, holograms, and hidden text in security or magnetic ink to protect against counterfeiting will become prominent in labelling.
Companies implement processes and systems to ensure the accuracy of the labelling information they put on their medical devices. US global medical device company, Arthrex, has developed a Global Enterprise Labelling System (GELS) to provide a simple approach to manage batch and centralise master product data relating to finished good labelling in the healthcare sector.
The upcoming Medical Device and Diagnostic Labelling Conference will focus on how manufacturers can utilise efficient methods to label their products while staying current with international requirements. At the forefront of the 13th annual conference will be understanding how manufacturers can quickly integrate new provisions with European standards, optimising localisation strategies and enhancing processes using labelling systems.