What are the labeling requirements for medical devices?

What are the labeling requirements for medical devices?

There is a very clear requirement that labeling must clearly identify the manufacturer of the device, including their name and place of business. If the device is manufactured for or distributed by another company, this must be shown on the label with a designation such as “manufactured for” or “distributed by.”

What is MDR Labelling?

According to the definitions in the European Union’s Medical Device Regulation (MDR) (Article 2) “label” means any 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.

Is ISO 15223 harmonized?

Will ISO 15223:2020 and ISO 20417:2020 be harmonized? A. It is expected that both standards will be harmonized to both Regulations.

What is the symbol for single patient use?

synonymous terms for “do not reuse” are “single use” or “use only once”. This wording can be replaced by the symbol: Figure: 1, Symbol for “Do Not Reuse”, taken from EN980: Graphical Symbols for Use in the Labelling of Medical Devices.

Are there special labeling requirements for investigational devices?

Yes. Under § 812.5 an investigational device or its immediate package must bear a label with the following information: the name and place of business of the manufacturer, packer, or distributor; the quantity of contents, if appropriate; and.

What does Rx only mean on medical devices?

FDA is also revising its prescription device labeling regulations to allow the use of the symbol statement “Rx only” or “℞ only” in the labeling for prescription devices.

What is Catalogue number in medical device?

ISO 7000 – 2493, Catalogue number. Function/description : To identify the manufacturer’s catalogue number, for example on a medical device or the corresponding packaging. The catalogue number shall be placed adjacent to the symbol.

Is ISO 13485 a harmonized standard?

The updated version of the EU quality system standard EN ISO 13485, which is relevant for the whole of the medtech industry, is now formally recognized as a “harmonized” standard in the context of the EU’s Medical Device Regulation.

Is EN 980 obsolete?

EN 980:2008 pertaining to symbols used in medical device labels no longer applies. EN ISO 15223-1:2016 replaces EN 980:2008 beginning January 1, 2018. EN ISO 11137:2015 for sterilization of healthcare products beginning January 1, 2018 (IVDD only)

What does the symbol 2 mean?

In math, the squared symbol (2) is an arithmetic operator that signifies multiplying a number by itself. The “square” of a number is the product of the number and itself. Multiplying a number by itself is called “squaring” the number.

What does the hourglass symbol mean on medical supplies?

This hourglass means our product has an expiration date of 3 years from its production date and that it must not be used after said date. Date of manufacture. Indicates the month and year of production and from when the expiration date must be counted.

What does CFL stand for in FDA?

consistent with the FDA-required labeling
FDA uses the acronym “CFL” as shorthand for the phrase “consistent with the FDA-required labeling.” In the draft guidance, FDA had stated that “{i}f a firm’s communication is consistent with the FDA-required labeling, that communication alone is not viewed by FDA as providing evidence of a new intended use.” (

What types of products require pi?

PI applies to all restricted medicines, and any other medicines for which a PI is required. Restricted medicines include: all medicines in Schedules 4 and 8 of the Poisons Standard regulated as prescription medicines.

What is the difference between PMA and 510 K?

A PMA is more in-depth than a 510k – it is used to prove that a new device is safe and effective for the end user and typically requires clinical trials with human participants along with laboratory testing.

What are the exemptions from labeling for Ivds?

Exemptions from Labeling Requirements – A product that is being shipped or delivered for product testing prior to full commercial marketing that is prominently labeled: “For Investigational Use Only. The performance characteristics of this product have not been established.”

What does pom stand for in medical terms?

A treatment that must be prescribed by a doctor and is not licensed for sale to the general public. A prescription medication is a licensed medicine that is regulated by law to necessitate a medical prescription before it can be obtained.

What is Gtin in medical device?

Global Trade Item Numbers (GTINs). GTINs are the device identifier portions of the UDIs. Each device is assigned a GTIN, just as each device is assigned a catalog number, and that GTIN will appear in a barcode on its packaging down to the unit of use level. Global Location Numbers (GLNs).

Is Gtin the same as Udi Di?

a Device Identifier (DI): a fixed code specific to a version or model of a device. It is also the identifier used to access the UDI Database. The GS1 Global Trade Item Number (GTIN) enables this aspect of the UDI.