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UK Cosmetics Requirements
26Sep 2024
Cosmetics, Registrations, UK admin Comments: 0

UK Cosmetics Requirements and Registration Process

The UK has specific regulations governing the safety, labelling, and marketing of cosmetic products. Post-Brexit, the UK has its own regulatory framework separate from the EU. UK Cosmetics Requirements & Registration Process This is an overview of the requirements and the registration process for cosmetics in the UK. 1. Regulatory Authority The main regulatory body overseeing cosmetic products in the UK is the Office for Product Safety and Standards (OPSS), which operates under the Departmen...
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Human Medicines
20Sep 2024
General Information, UK admin Comments: 0

UK-Wide Licensing for Human Medicines

1. Overview  This guideline gives information on how the Windsor Framework will be implemented in the UK regarding the licensing of medications for human use.   The Medicines and Healthcare Products Regulatory Agency (MHRA) will license medications throughout the United Kingdom starting on January 1, 2025.   The Human Medicines Regulations 2012 legislation, as amended by the Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024, and other pertinent...
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13Jul 2024
UK, 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 in...
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12Jul 2024
EU MDR, Swiss, UK Cubicdesignz Comments: 0

Navigating Medical Device Regulations: A Comprehensive Guide to Market Access in Europe, Switzerland, and the UK

Introduction and Guide to Market Access In the intricate landscape of medical device regulations, successfully bringing products to market requires a thorough understanding of the varying requirements in different regions. This market access guide provides comprehensive insights into the European Union (EU), Switzerland, and the United Kingdom (UK) regulations, shedding light on crucial aspects such as Authorized Representatives, Importers, and other economic operators.  Crafting your Marke...
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12Jul 2024
EU, Regulations, Swiss, UK Cubicdesignz Comments: 0

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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12Jul 2024
EU, Brazil, General Information, India, Swiss, UK, USA Cubicdesignz Comments: 0

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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05Feb 2024
EU, Brazil, FDA, General Information, IVD, Regulations, Swiss, UK, USA admin Comments: 0

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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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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05Feb 2024
EU, General Information, Regulations, UK Cubicdesignz Comments: 0

Exceptional Use Medical Devices in the EU and UK

Medical devices conforming with the medical device regulations must have a conformity marking. Medical devices that do not conform may still be placed in the market, provided they apply through the exceptional use devices pathway. This article discusses the exceptional use requirements to be satisfied to gain access to EU and UK markets. In the UK, the UKCA marking displays that the device conforms to UK Medical Device Regulations 2002. Without UKCA marking, the devices can only be placed in the...
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05Feb 2024
EU, Regulations, UK Cubicdesignz Comments: 0

7 SaMD Device Regulation (UK & Europe)

Under both the EU MDR and the EU IVDR, the MDCG rules specify the conditions for a product to qualify as medical device software (MDSW). An MDSW product can enter the market in one of the ways:   1. As a standalone medical device or   2. As a component of another medical device regulation.  The former demands a lengthy regulatory process that includes a conformity assessment to determine whether the medical device meets EU MDR requirements. However, that rule does not apply to products in...
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