Labelling & IFU

Labelling and instructions for use sit at the intersection of regulatory compliance and real-world device use — and they are inspected more closely under MDR than many manufacturers expect. The requirements are spread across Annex I Chapter III (Sections 23 and 24), Annex I itself, and the UDI rules in Annex VI and Article 27. Getting labelling wrong is not a minor paperwork issue: non-conforming labels are a basis for market withdrawal, and IFU gaps are a frequent audit finding that can block certification.

One thing that catches teams off guard is how detailed the mandatory label content requirements are under Section 23.2. It is not a short list. Name and address of the manufacturer, device name or trade name, basic UDI-DI, lot number, manufacturing date, expiry date where relevant, sterility indicators, warnings and precautions, intended purpose where not obvious — and the list extends further for implantable devices, devices with a measuring function, and devices containing or incorporating medicinal substances. Many manufacturers discover in pre-audit review that their labels meet MDD practice but not MDR's expanded list.

Instructions for use are required for all devices unless the device can be used safely and as intended without them — which is a narrow exception. The IFU content requirements in Section 23.4 are extensive and include the full intended purpose, contra-indications, installation and maintenance instructions, and details of any residual risks the user needs to be aware of. One area that trips up a lot of teams: the IFU needs to clearly describe what a serious incident looks like and instruct the user on how to report it. Most MDD-era IFUs don't include this, and it is now a hard requirement.

Symbols on labels must either appear in a recognised standard — ISO 15223 is the primary one — or be explained in the IFU. Using a symbol that is not in a harmonised standard without explanation is a labelling non-conformity. Electronic IFU (eIFU) is permitted under Regulation (EU) 207/2012 for certain device categories, subject to specific conditions: the user must be able to opt out and receive a paper copy, and the manufacturer must maintain eIFU availability throughout the device lifetime. Some manufacturers have switched to eIFU without fully meeting these conditions.

Language requirements are where multi-country distribution often creates problems. MDR requires labelling in the official language(s) of the EU member states in which the device is made available. There is no single EU-wide language requirement — you need the language of each country you sell in. Managing label variants across markets, keeping translation files aligned when the source label changes, and validating that translated content retains the meaning of the original — these are operational challenges that go beyond regulatory text. Resources in this category work through label content requirements, IFU structure, symbol management, eIFU conditions, language obligations, and how labelling connects to UDI assignment and EUDAMED label data registration.