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EU MDR

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Tag: EU MDR
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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20Mar 2025
EU MDR, EU Cubicdesignz

Technical Documentation Requirements MDD Vs MDR

Check out the difference between MDD vs MDR MDD vs MDR MDD A MDD Technical documentation must include: MDR All Technical documentation requirements of MDD must be presented for the MDR alongside the below additional list: Device Description and Specifications Information to be supplied by the manufacturer Design and Manufacturing Information General Safety and Performance Requirements Benefit-Risk Analysis and Risk Management The benefit-risk analysis, the solutions adopted, and the results of t...
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24Feb 2025
Registrations Cubicdesignz

Iraq Medical Device Registration: KIMADIA Guidelines and Requirements

Navigating Medical Device Registration with Iraq’s Regulatory Authority: KIMADIA Guidelines and Requirements  Regulatory Authority State Company for Marketing Drugs and Medical Appliances (KIMADIA)  “Kimadia” refers to the Iraqi State Company for Marketing Drugs and Medical Appliances. It is a governmental organization responsible for procuring and distributing pharmaceuticals and medical supplies within Iraq, including through tenders and procurement processes.  When “Kim...
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Regulatory Recap
09Jan 2025
News admin

Medical Device Regulatory Recap 2024 by OMC Medical Limited

In 2024, OMC Medical Limited achieved remarkable milestones while adapting to significant regulatory developments, reinforcing its global presence. Regulatory Recap 2024 Key Changes That Impacted Business Gaining Valuable Insights for Future Compliance Achievements This year solidified OMC’s position as a leader in medical device regulatory solutions. Read below to get more detailed information Regulatory News Recap 2024...
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28Oct 2024
EU MDR, Regulations Cubicdesignz

Regulation (EU) 2017/746 (IVDR): MDR IVDR Amendment Jan. 2023 

Introduction Recent amendments to Regulation (EU) 2017/745, also known as the Medical Devices Regulation (MDR), have introduced significant changes to the timelines and conditions for placing certain medical devices on the market or putting them into service. This comprehensive analysis explores the key points of these amendments, focusing on the intricate timeline considerations.  Paragraph 3 Amendments Paragraph 3 has undergone crucial revisions, introducing new provisions (3a to 3g) that...
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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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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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19Jul 2024
EU, EU MDR, General Information, IVD Cubicdesignz

Strategic Approach to Compliance: Mastering the Quality Management System (QMS) in EU MDR

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News July 13, 2024 Cubicdesignz

October Newsletter

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 14 October 2021 To prevent disruption in the supply of these essential healthcare products, the European Commission has proposed a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation introducing substantial changes in the regulatory framework for in vitro diagnostic medical devices, such...
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12Jul 2024
EU MDR, FDA Cubicdesignz

Mastering Medical Device Audits: A Roadmap to Preparedness and Compliance Excellence

Facing a medical device audit can be daunting, but with meticulous preparation and strategic responses, companies can turn this challenge into an opportunity for building a robust quality system. Tips for Mastering Medical Device Audits This article provides a detailed roadmap for mastering medical device audits, covering essential steps from internal audits to adeptly handling regulatory findings. 1. Demystifying Audits Understanding the fundamental concepts behind medical device audits is cruc...
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