The safe operation of a medical device must never come down to guesswork or trial and error. Informative, accurate labeling is required, and every label included with the device has to meet the applicable standards and regulations. When features or hazards are inadequately labeled, misuse can occur and result in harm to the user and a loss of confidence in the device. Good labeling prevents errors and ensures that the user will receive the intended benefits safely.

Medical device labeling is also a key element of manufacturers’ efforts to comply with the standards and regulations instituted by relevant regulatory bodies including the U.S Food and Drug Administration (FDA) and the European Union’s Medical Device Regulation (MDR).

In the US and the EU, the requirements for medical device labeling are detailed and extensive and may be specific to the type of device. Manufacturers should always refer directly to the text of the applicable laws to ensure that they are following the correct procedures and staying compliant.

US FDA Requirements

According to the US FDA, a label is any “display of written, printed, or graphic matter upon the immediate container of any article,” and must be clearly visible even if the “immediate container” has additional packaging. “Label” also includes anything printed on a product container or wrapper, or anything that accompanies the article when it is put up for sale. US courts have found that, by this definition, advertising, posters, brochures, instruction booklets, inserts, and any similar materials are also considered labels for regulatory purposes.

Labeling regulations pertaining to medical devices are found in the following Parts of 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 – 21CFR Part 830

Good Manufacturing Practices – 21 CFR Part 820

General Electronic Products – 21 CFR Part 1010

FDA-compliant labels must include the following information:

• The name and location of the business
• Intended device use
• Adequate instructions for the ordinary person to use the item safely
• Exemptions
• The label cannot include any false or misleading statements and the statements must be displayed prominently in an appropriate location.

Additionally, the FDA requires medical device manufacturers to use Unique Device Identification labels. UDI allows for the tracking of specific devices, and the required elements must be both printed and machine-legible.

EU MDR Requirements

The EU’s regulations are contained in Annex I, Chapter III of the EU MDR.

• Labelling Where devices, parts thereof or materials used, contain substances in a concentration above 0,1 % weight by weight (w/w), as referred to in Section 10.4.1 of EU MDR regulation, the presence of those substances shall be labelled on the device itself, and/or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances.
• If the intended use of such devices includes treatment of children or treatment of pregnant or breastfeeding women or treatment of other patient groups considered particularly vulnerable to such substances and/or materials, information on residual risks for those patient groups and, if applicable, on appropriate precautionary measures shall be given in the instructions for use.
• The labelling of the device shall distinguish between identical or similar devices placed on the market in both a sterile and a non-sterile condition additional to the symbol used to indicate that devices are sterile.

General requirements the label shall bear all of the following particulars:

(a) The name or trade name of the device;

(b) The details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device;

(c) The name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business;

(d) If the manufacturer has its registered place of business outside the Union, the name of the authorized representative, and address of the registered place of business of the authorized representative;

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

(f) Where applicable, information labeled in accordance with Section 10.4.5 of MDR;

(g) The lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, as appropriate;

(h) The UDI carrier referred to in Article 27(4) and Part C of Annex VII of MDR;

(i) An unambiguous indication of the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant;

(j) Where there is no indication of the date until when it may be used safely, the date of manufacture;

(k) An indication of any special storage and/or handling condition that applies;

(l) If the device is supplied sterile, an indication of its sterile state and the sterilization method;

(m) Warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person;

(n) If the device is intended for single use, an indication of that fact;

(o) If the device is a single-use device that has been reprocessed, an indication of that fact, the number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles;

(p) If the device is custom-made, the words ‘custom-made device’;

(q) An indication that the device is a medical device;

(r) In the case of combination devices that are intended to be introduced into the human body, the overall qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action;

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