Labeling requirements for medical devices
By Dalia Givony
Regulatory requirements for the medical device industry are constantly changing, which can be quite challenging for manufacturers and distributors that need to comply with a variety of country-specific registration requirements.
US Food & Drug Administration (FDA):
High quality labeling is necessary to ensure device performance as well as patient and user safety. As such, the use of FDA recognized labeling standards is highly recommended and can facilitate your approval/clearance process. FDA labeling requirements can be found in 21 C.R.F part 801. You may also refer to ISO 15223-1, an international standard recognized by the FDA for use of symbols on medical device labeling.
Note: The FDA constantly publishes new guidelines which can assist companies to better understand the regulatory requirements, so be sure to reference the most current information available.
EU CE marking:
CE mark is a specific certification demonstrating that a product meets EU health, safety and environmental requirements. In order to apply a CE mark on a medical device, you must demonstrate compliance with the EU Medical Device Directive/Regulation (MDD/MDR) which defines labels as “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".
The MDD/MDR requires that labeling will be provided in plain language that is clearly comprehensible to the end user. ISO 15223-1, EN 1041 harmonized standards, may serve as a reference for labeling requirements.
If you wish to sell a medical device in Israel, you’ll need to demonstrate compliance with the requirements of the Medical Device Division of the Israeli Ministry of Health (AMAR).
Israel does not have its own classification system for medical devices, but it accepts the classification method and the applicable regulatory requirements of the United States, EU, Australia and Canada. As such, products that are FDA approved or EU CE marked should already have the essential parts of the device dossier required to complete the registration process in Israel.
Still, there are some specific requirements related to labeling translation in Israel. For example, the Israel Ministry of Health has different translation requirements for devices intended for professional use and devices intended for home use.
In Israel, when the device is intended for professional use in healthcare facilities, the labeling may be provided in English-only. When the device is intended for home use, labeling must be provided in three languages: Hebrew (Israel’s official language), Arabic and English.
Need help defining labeling requirements for your product?