The Significance Of Labelling Medical Devices

By Author: Ruben Marcus
Total Articles: 18
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Just like the norms set up for pharmaceutical label printing, the FDA also demands compliance with respect to labelling medical devices. This norm pertains to restorative, diagnostic, cosmetic and therapeutic devices for the benefit of assuring safety and efficiency during use by a patient, caregiver, medical or paramedical professional. The idea is to communicate safety and performance related information as well as identify individual devices to users of the medical equipment in question.

In addition to the FDA, a number of governments such as those in the European Economic Area (EEA) also demand the CE marking on medical devices to facilitate effective quality management and compliance to certain derivatives.

Permissible Label Printing Formats

Written, graphic or printed matter which helps identify the device, elaborate its technical details and offers instructions of use; and is attached to the medical device, its packaging, containers, wrappers or simply accompanies it, is permitted under the FDA norms of labelling medical devices ...
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Typically, pharmaceutical label printing can be done on Medical devices and can be supplied in various different formats such as patient brochures, leaflets, user manuals as well as video based instructions as long as it offers the prescribed information with the exception of professional counselling to patients and lay caregivers.

This labelling must also be affixed with devices that are intended to be operated solely by medical professionals; by professionals and patients as well as devices that are typically operated only by patients and lay caregivers.

Significance of Medical Device Labelling

CE Marking of medical devices and other such labelling norms intend to promote assurance in safety and effective use of medical devices. Manufacturers must provide comprehensive information to ensure that the device is utilized as intended.

1. The labels offer vital information to patients, caregivers and professionals about the benefits and risks of the devices being used and also offer details with respect to its functions, care and maintenance.

2. It provides information with respect to how it interacts with the human body, and its core purpose in the entire patient care regimen.

3. The label also offers instructions with respect to the area or place in which it can be used and information pertaining to safety and disposal instructions.

With more patients opting to operate complex medical devices in the comforts of their homes, it has become even more crucial for manufacturers to communicate detailed instructions with respect to safety and efficiency in utility, maintenance and disposal.