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30May 2025
EU MDR, Swiss, UK Cubicdesignz

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

Introduction and Guide to Market Access in Europe, Switzerland, and the UK 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 o...
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Global Labelling Requirements
30May 2025
EU, Blogs, FDA, General Information, Regulations, UK, USA admin

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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2024 UK post-market surveillance (PMS) amendments
24Apr 2025
Trending Now, Blogs, Medical Device, UK OMC Medical Limited

What the 2024 UK Medical Device PMS Amendments Mean for Manufacturers?  

In a significant move towards improving patient safety and product oversight, the UK has introduced new post-market surveillance (PMS) requirements under the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024. These regulations, effective from 16 June 2025, amend the UK Medical Devices Regulations 2002 by adding a new Part 4A, which outlines comprehensive PMS requirements for medical devices, including in vitro diagnostic (IVD) devices and active...
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10Mar 2025
EU, Regulations, Swiss, UK Cubicdesignz

SaMD Devices Classification

SaMD is software intended for one or more medical purposes that perform these without being part of a hardware medical device. Medical device software is meant to be used, alone or in combination, for a purpose specified in the definition of a “medical device” in the MDR or IVDR, regardless of whether the software is independent or driving or influencing the use of a device. You can read more on the SaMD Regulation here. To be qualified as medical device software, the product must first...
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UKCA vs CE Marking
03Mar 2025
Trending Now, Blogs, UK admin

UKCA vs. CE Marking: What’s the Difference and Which One Do You Need?

In today’s global marketplace, ensuring product compliance is essential for manufacturers looking to sell in different regions. If you are marketing products in the United Kingdom (UK) or the European Union (EU), understanding the differences between UKCA and CE marking is crucial. While both markings serve as indicators of product conformity, they apply to different regulatory frameworks.  Let’s begin,  What is CE Marking?  CE marking (Conformité Européenne) is a certificat...
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UK Medical Device Registration Process
14Feb 2025
Medical Device, Trending Now, UK admin

UK Medical Device Registration: Everything You Need to Know  When it comes to introducing your medical device to the UK market, compliance with the Medicines and Healthcare Products Regulatory Agency (MHRA) is a must. The MHRA is responsible for ensuring that all medical devices in the UK meet the highest standards of safety and efficacy.  In this guide, we’ll walk you through everything you need to know about the United kingdom Medical Device Registration process, from the initial c...
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UK Responsible Person
29Jan 2025
UK, Trending Now admin

Responsibilities of UK Responsible Person (UKRP) 

To place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are required to appoint a UK Responsible Person.  The UK Responsible Person must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person. Importers and distributors are not required to appoint a UK Responsible Person.  Obligations of UK Responsible Person (UKRP) 1. Declaration of Conformity and Technical Documentation Verif...
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18Oct 2024
EU, Regulations, Swiss, UK, USA Cubicdesignz

Summary of Safety and Clinical Performance (SSCP)

Summary of Safety and Clinical Performance (SSCP) acts as a vital document that allows the public to access information quickly. The information in the SSCP can be sourced entirely from the technical file. The technical file consists of the Post Market Surveillance (PMS), risk assessment, post-market clinical follow-up (PMCF) plans and reports. The SSCP document is required for high-risk devices only-this includes Class III and all implantable devices. Manufacturers of custom-made or investigati...
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18Oct 2024
EU, Regulations, UK Cubicdesignz

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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18Oct 2024
EU, General Information, Regulations, UK Cubicdesignz

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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