Medical device labeling is essential in the MedTech industry, ensuring the safe and effective use of products for patients, healthcare providers and regulatory agencies. Adhering to evolving regulatory requirements is critical, as standards are continually updated and have strict criteria.

The European standard EN 1041:2008+A1:2013, which outlined manufacturer-supplied information, was recently replaced by EN ISO 20417:2021. This revised standard broadens the scope of labeling requirements, specifying general requirements for identification, labels, packaging, marking and accompanying information for medical devices and accessories. EN ISO 20417:2021 aligns with the latest EU Medical Device Regulations and international standards, enhancing the clarity and comprehensiveness of information to support safe and effective device use. Following are the few important highlights of these new standards.

• Expanded scope: The new standard encompasses a broader range of medical devices and accessories, specifying requirements for identification, labels, packaging, marking and accompanying information without prescribing language or supply means. It supersedes EN 1041:2008+A1:2013 to comply with updated EU regulations.
• Harmonization and inclusivity: EN ISO 20417:2021 harmonizes with international standards and includes provisions for electronic documentation, such as electronic instructions for use (eIFU), emphasizing accessibility, legibility and comprehensibility to ensure user-friendly information.
• Updated terminology: The revision introduces numerous new and modified terms and definitions related to medical device labeling and information, including accessory, accompanying information, commercial product identifiers and safety signs, while deleting outdated terms.
• Enhanced labeling requirements: The standard details minimum label requirements, including manufacturer identification, safety signs, durability, legibility and packaging information, with new clauses on residual risk, unique device identifiers and type of use or reuse.
• Annex updates: Several new annexes provide guidance aligned with current EU Medical Device Regulations, including references to essential principles, safety and performance requirements, test methods for legibility and durability and terminology indexes, replacing and expanding previous annexes.
• Manufacturer information formats: The standard recognizes multiple formats for supplying medical device information to ensure safe and effective use, supporting both traditional and electronic means.
• Industry expertise: HCLTech offers comprehensive medical device labeling solutions, including regulatory compliance support, translation, design and development of IFUs and eIFUs and automation technologies to facilitate adherence to evolving labeling requirements.

Our latest whitepapers presents comprehensive overview of the updates and enhancements made to the requirements for information supplied by medical device manufacturers. The whitepaper serves as a guide for medical device manufacturers to understand and comply with the latest regulatory requirements, ensuring the safe and effective use of their products. Download it now.