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Global Labelling Requirements

Label, Labelling vs Instructions for Use (IFU)? What are the minimum requirements for labeling? The ISO has published many standards applicable to the medical device industry. Some of them are as below: Standard Number Standard Name ISO 18113   In vitro diagnostic medical devices – Information supplied by the manufacturer (labelling) – Part 1, 2, 3, 4 and 5 ISO 28219 Packaging – Labelling and direct product marking with linear bar code and two-dimensional symbols ISO 15223  ...
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Field Safety Corrective Action (FSCA) – US FDA

What is Medical Device Reporting? Medical Device Reporting (MDR) is one of the FDA’s post-market surveillance techniques for monitoring device performance, detecting potential device-related safety concerns, and contributing to device benefit-risk assessments. What Event Qualifies to be Reported? Who can Report an Adverse Event to FDA? It is considered mandatory for the manufacturers, importers, and device user facilities) of reporters to report any adverse event through form FDA 3500A. T...
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Field Safety Corrective Action (FSCA) – Swiss

What is a Field Safety Corrective Action? Any action performed to reduce the risk of death or serious deterioration in health connected with the use of a medical device is referred to as Field Safety Corrective Action (FSCA). The manufacturer is required to take action to remove or limit the risk of the recognised dangers. If a medical device malfunctions in Switzerland, the manufacturer is required to undertake an FSCA and Swissmedic keeps track of all FSCAs regarding medical equipment sold in...
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EU Requirements for Translations

Under the Medical Devices Directive (MDD), it is required that manufacturers have translations of the technical documents like Instructions for Use. However, this rule wasn’t strictly followed up until MDR was brought in place. The European Union’s language requirements information can be found in Article 41 and Annex 1 (Chapter 3) of the EU MDR. Language requirements: EU Requirements for Translations As per MDR 2017/745, the information provided with medical devices needs to be tr...
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EU MDR – Language Requirements  

October 2021.   The EU MDR 2017/745 brings more safety to the device in the European market. As part of the Safety measure for the largest medical device market in the world EU Union has made measures to make sure the product sold in the EU market is accessible for everyone at the same time is safe and traceable at every stage of the product lifecycle. The new regulation has made measure that a professional user as well as a lay person can understand the correct usage of the devic...
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