EU MDR Labeling – Are You Prepared?
Definitions to Know
Written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices.
Instructions for Use
The information provided by the manufacturer to inform the user of a device’s intended purpose and proper use and of any precautions to be taken, for example: websites, GUDID, EUDAMED, marketing materials.
Published information regarding the identification, use, specifications, manufacture or limitations of a medical device.
Did you know? The word information appears 362 times in the regulation, more than any other word including risk.
Prohibited Acts (Article 7)
Ensure you do not mislead the user or the patient about the device’s intended purpose, safety and performance by:
- Attributing functions and properties to the device which the device does not have.
- Failing to inform the user or the patient of a likely risk.
Economic Operators (Articles 13, 16)
- Indicate company name and the address. Do not obscure the label provided by the manufacturer.
- If a distributor or importer modifies a device, be sure to indicate the activity carried out together with its name, trade name or trademark and the address of the distributor or importer.
Labeling / IFU Accompanying the Device (Articles 18, 21)
You need to provide instructions for use (IFU) along with your device. The IFU should include:
- Cleaning and disinfection procedures.
- Packaging and validated method of re-sterilization.
- Information on appropriate processes for reuse.
- Maximum number of reuses.
- Signs of material degradation.
- Procedures for safe disposal of devices after use.
- For devices intended for use by lay persons, note the circumstances in which the user should consult a health care professional.
Content of the Device Labels (Articles 20, 22, 27)
On your label you will need to indicate:
- If the device contains or incorporates a medicinal substance, a human blood or plasma derivative, or tissues or cells.
- Hazardous substance information.
- If the device is sterile, indication of its sterile state and the sterilization method.