Labelling Compliance
Labelling represents one of the most visible and closely scrutinised aspects of medical device and in vitro diagnostic compliance. Under the MDR and IVDR, manufacturers are required to communicate critical information related to device identification, safety, and performance through labels, packaging, and Instructions for Use (IFU). Each element must reflect the device’s intended purpose, correctly convey applicable warnings, and maintain consistency with the technical documentation and regulatory submissions. Errors or omissions in labelling not only create regulatory findings but can also compromise patient safety and trigger costly recalls.
Our Labelling Compliance services provide manufacturers with a comprehensive framework for achieving and maintaining conformity with MDR Annex I, Chapter III, and relevant MDCG and ISO 15223-1 standards. We begin with a detailed assessment of existing labelling materials, comparing content, layout, and symbology against applicable regulatory and linguistic requirements. This review includes verification of the use of harmonised symbols, translation accuracy, and alignment with the declared intended use and performance claims. Each discrepancy is documented and prioritised according to its potential compliance and safety impact.
We then support clients in establishing a structured labelling control process within their quality management system. This includes defining ownership, version control, and approval workflows to ensure that all labelling content undergoes formal review prior to release. Our consultants assist in designing templates for labels and IFUs that standardise formatting and ensure traceability to specific device models and configurations. We also provide guidance on integrating labelling change control with technical documentation updates and UDI assignments to maintain synchronisation across all regulatory systems.
Language and translation management form a critical component of compliance. We help organisations implement multilingual labelling processes that satisfy national language requirements across the European Economic Area. This includes managing translation verification, maintaining consistency between versions, and ensuring that outsourced translation providers operate under qualified supplier agreements.
In addition, we support manufacturers in implementing electronic labelling (eIFU) strategies where permitted, balancing regulatory obligations with sustainability and efficiency objectives. Our team ensures that eIFU systems meet accessibility, traceability, and validation requirements while maintaining compliance with Commission Regulation (EU) No 207/2012 and associated guidance.
For manufacturers updating labelling to meet MDR or IVDR transition requirements, we coordinate content alignment across technical documentation, clinical evaluation reports, and marketing materials. This ensures that all claims and warnings are supported by objective evidence and that labelling content accurately reflects the current device risk profile and intended purpose.
By ensuring that every label and IFU communicates accurate, verified, and regulator-approved information, organisations demonstrate their commitment to safety, transparency, and quality. Our services provide the structure and expertise required to achieve and sustain labelling compliance under the MDR and IVDR.
For further information on how our Labelling Compliance services can strengthen your regulatory documentation and product safety communication, please contact our quality and regulatory affairs team.
