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Cubicdesignz

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Author: Cubicdesignz
Page 11
05Feb 2024
News Cubicdesignz Comments: 0

Symbols used in Labelling

There are multiple symbols used in labelling, but what are the harmonised standards that are internationally accredited. ISO 15223-1: 2021 – Medical Device Symbols released in July 2021 provides standardised symbols recognised by the international community. European union has harmonised this under the MDR and has allowed a transition period of March 2022. However, FDA still hasn’t approved this but the previous version ISO 15223-1:2016 is approved by FDA. Some symbols that are not standardi...
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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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05Feb 2024
EU, Regulations Cubicdesignz Comments: 0

EU Declaration of Conformity

The Declaration of conformity (DoC) is one of the key documents within technical documentation. Technical documentation is necessary for manufacturers as this is a detailed record that provides essential information on the design, manufacture, and operation. EU Declaration of Conformity is signed by the manufacturer to declare that the products comply with the EU requirements. By signing it, the manufacturer takes full responsibility for the product’s compliance with the applica...
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05Feb 2024
Regulations Cubicdesignz Comments: 0

UK Declaration of Conformity

After Britain leaving the EU, there have been many changes in the regulations regarding medical devices. An example of this is the UK’s Declaration of Conformity. UK Declaration of Conformity (DoC) is a technical document that products with UKCA marking should possess. The information needed on the Declaration of Conformity (DoC) is largely the same as what was required on an EU Declaration of Conformity. According to UK’s guidance on UKCA marking, manufacturers are recommended to keep...
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05Feb 2024
Authorised Representatives Cubicdesignz Comments: 0

Switzerland Medical Device Regulations

Switzerland Market Situation Switzerland Market Situation – Downside Switzerland- Medical Device Regulations Medical devices are regulated by: the Swiss Agency for Therapeutic Product Manufacturers Outside Swiss – Proxy to the foreign manufacturer – Responsible for product safety – Liable for product defects – contact person for Swiss authorities – can be a legal entity or a natural person – must have access to PRRC Roles of Swiss AR’s PRRC Liability of a Swiss AR Manufacturer Re...
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Swiss Authorized Representative
05Feb 2024
Authorised Representatives Cubicdesignz Comments: 0

Labelling Requirements – Swiss Authorized Representative

Labelling Requirements – Swiss Authorized Representative Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices (Art. 2 point 13 MDR). Timeline for Information on Indication of CH-REP “on the device” or “in the accompanying document.” The provision for indication of CH-REP comes into effect on 26 May 2021 and is timeline based, applicable to devices of all classes (Class I, IIa, IIb, III)....
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05Feb 2024
Registrations Cubicdesignz Comments: 0

Medical Device Registration in Romania

Ministry of Health     Ministry of Health Regulatory Authority      National Agency for Medicines and Medical Devices of Romania (NAMMD) Medical Device Regulation          EU MDR 2017/745 EU IVDR 2017/746 Official Language     Romanian Classification of Medical Devices  Class I, IIa, IIb and III Registration Process 1. Determine the device classification 2. Appoint an Authorized Representative and Notified Body 3. The medical devices must be registered in the NAMMD da...
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05Feb 2024
Registrations Cubicdesignz Comments: 0

Labelling Requirements – Swiss Authorized Representative

Labelling Requirements – Swiss Authorized Representative Written, printed, or graphic information appears either on the device itself or on the packaging of each unit or the packaging of multiple devices (Art. 2 point 13 MDR). Timeline for Information on Indication of CH-REP “on the device” or “in the accompanying document.” The provision for indication of CH-REP comes into effect on 26 May 2021 and is timeline based, applicable to devices of all classes (Class I, IIa, IIb, III)....
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05Feb 2024
Registrations Cubicdesignz Comments: 0

Labelling Requirements

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05Feb 2024
Registrations Cubicdesignz Comments: 0

“Professional use” Test Kit – Procedure for registration in UK 

“Professional use” Test Kit – Procedure for registration in UK  Novel Corona Virus Disease 2019 (COVID-19) is a different variety of disease that has never been seen in humans before, impacting being a pandemic, and affecting the world since the year 2020. One of the most difficult aspects of coronavirus is the ambiguity of not knowing who has been infected or whether it is safe to resume normal activities. Testing of high quality might assist provide assurance. However, no good thing...
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