Table of Contents
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.
What is private label in medical device?
A Private Label Manufacturer (PLM) purchases a finished (or component parts of a) medical device from the Original Equipment Manufacturer (OEM), which he then places on the market under his own name or trade mark (brand label).
Why is medical device labeling important?
Medical device labeling is essential to assure safe and effective use of many, but not all, devices. It informs patients or their lay caregivers about proper use, risks, and benefits of the device in language they can understand[4].
What are labeling requirements?
The Fair Packaging and Labeling Act (FPLA or Act), enacted in 1967, directs the Federal Trade Commission and the Food and Drug Administration to issue regulations requiring that all “consumer commodities” be labeled to disclose net contents, identity of commodity, and name and place of business of the product’s …
Why labels and labeling is critical for medical devices?
Medical device labelling is a critical part of the medical device manufacturing process. Accurate labelling of medical devices is vital to ensuring market access, and the safe and proper use of medical devices by patients and care givers.
What is an EC rep?
What is an Authorised Representative (EC REP)? Essentially, an EC REP plays an intrinsic part in post-market surveillance, including vigilance. The Authorised Representative (AR) is your link to European authorities, and they must maintain physical presence in Europe.
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.
What is OEM in PLM?
OEM, PLM – what does it all mean? An Original Equipment Manufacturer (“OEM”) is a company that produces finished products for a PLM, undergoes a conformity assessment, but usually does not act as a manufacturer in the sense of medical device law.
What is an OBL agreement?
The term Own Brand Labeling (OBL) refers to the particular procedure that a medical devices manufacturer should follow when marketing devices bearing a CE marking in its own name (“me too” device).
What does patient label mean?
Patient Labels can be generated for a number of reasons. Some examples are: The practice has moved to a new location and all patients need to be notified via mail. A provider is leaving the practice and patients that see that provider need to be notified via mail.
What is the difference between label and Labelling?
Labeled and labelled are both correct spellings. Labeled is the preferred spelling in American English. Labelled is the preferred spelling in British English.
What does it mean to label someone?
Labelling or using a label is describing someone or something in a word or short phrase. For example, the label “criminal” may be used to describe someone who has broken a law. Labelling theory is a theory in sociology which ascribes labelling of people to control and identification of deviant behaviour.