Labelling and Instructions for Use Review
Practical RA provides regulatory review of labelling and Instructions for Use to support compliance with EU MDR and IVDR requirements.
Why Labelling Matters
Labelling and Instructions for Use are the primary means by which manufacturers communicate safe and effective use of a device to users. Under the EU MDR and IVDR, labelling requirements are detailed and closely scrutinised by regulators and Notified Bodies. Labelling must accurately reflect the intended purpose, clinical performance, residual risks, and regulatory status of the device.
A common regulatory issue is misalignment between labelling and supporting documentation. Claims made on labels or in IFUs must be supported by clinical evidence and consistent with the intended use defined in the technical documentation. Where claims exceed the available evidence, or where warnings and precautions do not reflect known risks, regulatory findings are likely.
The MDR and IVDR also introduce specific requirements for symbols, language, and regulatory information. Devices supplied in the EU must meet language requirements of the Member States where they are made available, and symbols must be used in accordance with recognised standards where applicable. In addition, UDI-related information must be correctly presented for devices subject to these requirements.
Labelling must also be maintained throughout the device lifecycle. Changes to device design, risk profile, or post-market findings may necessitate updates to IFUs or packaging. Regulators expect manufacturers to demonstrate control over labelling changes and to assess their regulatory impact.
From a practical perspective, labelling is often one of the first elements reviewed during regulatory assessment. Clear, compliant labelling supports efficient review and reduces the likelihood of questions or non-conformities.
How Practical RA Can Support
Practical RA provides labelling and IFU review services, including:
- Review of labels and IFUs against MDR and IVDR requirements
- Consistency checks with intended use and technical documentation
- Verification of warnings, precautions, and claims
- Review of symbols, language requirements, and regulatory information
- Support for labelling updates following regulatory or post-market changes
Our focus is on producing documentation that is clear, consistent, and defensible from a regulatory review perspective.
