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Medicinal Products for Human
30Sep 2024
Blogs, General Information admin Comments: 0

Labelling and Packaging of Medicinal Products for Human use following Agreement of the Windsor Framework

1. Overview This guidance aims to outline the labelling and packaging requirements for medicinal products intended for human use, following the agreement of the Windsor Framework. It should be used alongside the existing guidance for wholesale dealers and manufacturers. The Windsor Framework establishes long-term arrangements for the distribution of medicines in Northern Ireland. It ensures that medicines can be approved and licensed throughout the UK by the Medicines and Healthcare products Reg...
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Global Labelling Requirements
05Feb 2024
EU, Blogs, FDA, General Information, Regulations, UK, USA admin Comments: 0

Global Labelling Requirements

Label, Labelling vs Instructions for Use (IFU)? 1. A Label is the written, printed, or graphic information that goes on the packaging of the medical device. 2. Instructions For Use (IFUs) or Package Insert is the essential information accompanying the medical device for its safe and effective use by the user. It can be a single to multiple-page document. 3. Labelling is the content that goes on the Label or IFUs. What are the minimum requirements for labeling? The ISO has published many standard...
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FSCA
05Feb 2024
Regulations, Blogs, Swiss admin Comments: 0

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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05Feb 2024
EU, Blogs, Regulations Cubicdesignz Comments: 0

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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05Feb 2024
Blogs, EU, Regulations Cubicdesignz Comments: 0

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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