Medical Device Labelling Requirements

effective operation of a medical device must never rely on guesswork. Clear, accurate, and compliant labeling is essential, and every label associated with a device must meet the relevant regulatory standards. When important information or hazards are not properly identified, improper use may occur, potentially causing harm and diminishing trust in the device. Proper labeling helps prevent misuse and ensures that users benefit from the device as intended.

Labeling also plays a critical role in ensuring manufacturers meet regulatory obligations established by authorities such as the U.S. Food and Drug Administration (FDA) and the European Union’s Medical Device Regulation (MDR).

In both the U.S. and the EU, medical device labeling requirements are extensive and may differ by device type. Manufacturers should always consult the original legal texts to confirm compliance.

US FDA Requirements

The FDA defines a label as any “display of written, printed, or graphic matter upon the immediate container of any article,” and it must remain visible even if additional packaging is used. This definition also covers any printed material on a wrapper or anything accompanying the product when sold. U.S. courts have interpreted this broadly to include advertising, brochures, inserts, posters, instruction manuals, and similar materials.

Key FDA labeling regulations for medical devices appear in Title 21 of the Code of Federal Regulations (CFR):

• General Device Labeling – 21 CFR Part 801 
• Use of Symbols – 21 CFR Part 801.15 
• In Vitro Diagnostic Products – 21 CFR Part 809 
• Investigational Device Exemptions – 21 CFR Part 812 
• Unique Device Identification – 21 CFR Part 830 
• Good Manufacturing Practices – 21 CFR Part 820 
• General Electronic Products – 21 CFR Part 1010

FDA-compliant labels must include:

• Manufacturer’s name and location 
• Intended use of the device 
• Instructions sufficient for an ordinary user to operate the device safely 
• Applicable exemptions 
• No false or misleading information, with statements clearly and prominently displayed

Additionally, the FDA requires the use of a Unique Device Identifier (UDI), which allows for individual device tracking. The UDI must be presented in both readable and machine-scannable formats.

EU MDR Requirements

EU labeling requirements are outlined in Annex I, Chapter III of the MDR.

When a device, or any of its components or materials, contains a substance in concentrations above 0.1% weight by weight (as described in Section 10.4.1 of the MDR), the presence of such substances must be indicated either on the device itself, on unit packaging, or on sales packaging. If the device is intended for use with children, pregnant or breastfeeding women, or other vulnerable groups, the instructions for use must include information on residual risks and appropriate precautions.

Labels must also clearly distinguish between devices marketed in sterile and non-sterile conditions, along with the relevant sterilization symbols.

General EU MDR labeling requirements

The label must contain all of the following:

(a) Device name or trade name 

(b) Details needed for the user to identify the device, packaging contents, and intended purpose if not obvious 

(c) Manufacturer’s name, registered trade name, or trademark, and business address 

(d) If the manufacturer is based outside the EU, the authorized representative’s name and address 

(e) Where applicable, an indication that the device contains or incorporates certain materials 

(f) Any information required under Section 10.4.5 of the MDR 

(g) Lot number or serial number, identified with the words LOT NUMBER or SERIAL NUMBER or the corresponding symbol 

(h) UDI carrier as described in Article 27(4) and Annex VII, Part C 

(i) Expiration date, expressed at least by year and month, when relevant 

(j) If no expiration date applies, the date of manufacture 

(k) Special storage or handling conditions 

(l) Sterile state and sterilization method, if supplied sterile 

(m) Warnings or precautions requiring immediate attention 

(n) Indication if the device is intended for single use 

(o) Indication if a single-use device has been reprocessed, including number of reprocessing cycles and limits, if applicable 

(p) The words “custom-made device,” if relevant 

(q) Confirmation that the item is a medical device 

(r) For combination devices intended for introduction into the human body, qualitative composition and quantitative details of the main active constituents 

(s) Serial number for active implantable devices, and serial or lot number for other implantable devicesfor other implantable devices, the serial number or the lot number.