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17Oct 2024
EU, EU MDR, Registrations Cubicdesignz

MDCG Guidance for Manufacturers of Class I Medical Devices

A medical device’s intended use and inherent risks must be considered when determining its MDR classification. Class I devices pose less risk to patients and end users, as under the previous MDD. The new Regulation EU MDR 2017/745 has added extended rules, leading some devices to fall under Class IIa, IIb, or even III.  This document is intended to guide Class I medical device manufacturers (excluding custom-made devices) that sell products bearing their name or trademark on the Union mar...
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16Oct 2024
EU, Registrations, Regulations Cubicdesignz

Requirements of Technical Documentation EU MDR

Technical documentation should contain details of the medical device in a clear, organized, readily searchable and unambiguous manner. It should be provided with all medical devices irrespective of the device class and to be kept updated throughout the product life cycle. Technical documentation is to be prepared according to the requirements given in Annex II of EU MDR 2017/745. Requirements of Technical Documentation as per Annex II 1. Device description and specification, including varia...
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16Oct 2024
Registrations, EU, EU MDR Cubicdesignz

MDCG Guidance for Manufacturers of Class I Medical Devices

A medical device’s intended use and inherent risks must be considered when determining its MDR classification. Class I devices pose less risk to patients and end users, as under the previous MDD. The new Regulation EU MDR 2017/745 has added extended rules, leading some devices to fall under Class IIa, IIb, or even III.  This document is intended to guide Class I medical device manufacturers (excluding custom-made devices) that sell products bearing their name or trademark on the Union mar...
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14Oct 2024
EU, FDA, General Information, Regulations, Swiss, USA admin

Nomenclature of Medical Devices

Medical device nomenclatures are those products used to prevent, diagnose, treat, and monitor the many diseases known to humankind. Medical devices and medicines play an equally important role in treating human beings. To learn more about medical devices, read our article on the definition of a medical device. This article discusses the nomenclature of medical devices and examples of these. What is the Nomenclature of Medical Devices? To simply put it, the nomenclature is the naming of a me...
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11Oct 2024
EU, Brazil, General Information, India, Swiss, UK, USA Cubicdesignz

Testing Standard Requirements around the World

Medical device testing standard- an overview Medical device testing is a crucial step in manufacturing a product. This mandatory process ensures that the medical device is safe and effective. Testing of medical devices proves that the product complies with the standards and regulations of a country. Moreover, it also sheds light on any product defects. This article discusses the testing requirements and the applicable standards. Medical device testing applies to all medical devices, in-vitro dia...
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11Oct 2024
EU, Regulations, Swiss, UK Cubicdesignz

Top 7 Guidance On Class I Medical Devices

The EU MDR 2017/745 imposes more stringent requirements for Class I devices. Under the new regulations, Manufacturers must righty classify a medical device and provide technical documentation following the device class. The risk class under MDD could change under MDR. In some cases, medical devices could be up classified from Class I medical devices to Class II a/b medical devices or Class III medical devices. Please read our article on the classification of medical devices to understa...
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Windsor Framework
23Sep 2024
EU, General Information admin

What Manufacturers and Wholesalers Should Know About MHRA Compliance and the Windsor Framework?

This essential guidance is tailored for manufacturers and wholesale dealers authorized by the Medicines and Healthcare products Regulatory Agency (MHRA). It serves as a comprehensive resource for Qualified Persons (QPs), Responsible Persons (RPs), and Responsible Persons for Import (RPis) to effectively implement the Windsor Framework’s new arrangements for human medicines. Key Responsibilities for Marketing Authorization Holders (MAHs) Marketing Authorization Holders must communicate any chan...
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20Sep 2024
EU, Blogs, Regulations Cubicdesignz

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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29Aug 2024
EU, Brazil, FDA, General Information, IVD, Regulations, Swiss, UK, USA admin

Global ISO Requirements

What is ISO? ISO – International Organization for Standardization, is the international, non-governmental body for drafting and establishing technical and non-technical standards. These standards are developed by different committees within the International Organization for Standardization. Having around 165 member states, with one representative from each, International Organization for Standardization is a global entity catering to the needs of industry requirements. Are ISO standards impor...
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26Aug 2024
EU, Regulations Cubicdesignz

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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