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EU MDR

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Tag: EU MDR
13Jul 2024
Registrations Cubicdesignz Comments: 0

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 “Kimadia...
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News July 13, 2024 Cubicdesignz Comments: 0

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 Comments: 0

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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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 MDR, Regulations Cubicdesignz Comments: 0

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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12Jul 2024
EU MDR, General Information Cubicdesignz Comments: 0

The Role of Notified Bodies in Assessing Clinical Evaluation Reports (CERs) under EU MDR

Clinical evaluation is a continuous procedure that happens at every stage of a medical device’s life cycle. It is typically carried out initially in the course of developing a medical device to determine what data must be produced to gain access to the market. The first CE-marking must include a clinical evaluation, and it must be regularly updated going forward. Clinical evaluation is essential and significant because it guarantees that assessments of the device’s performance and sa...
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12Jul 2024
EU, EU MDR Cubicdesignz Comments: 0

EU Notified Body

A notified body is an independent organisation designated by an EU country to assess the conformity of products before being placed on the market. Under EU MDR 2017/745, the notified body is also called a conformity assessment body.   A conformity assessment body (CAB) or a notified body is responsible for carrying out the conformity assessment procedure mentioned in the applicable Regulation. What does a notified body do? A notified body assesses whether the product conforms to the require...
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12Jul 2024
EU MDR, EU Cubicdesignz Comments: 0

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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12Jul 2024
EU, EU MDR, General Information, IVD Cubicdesignz Comments: 0

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

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12Jul 2024
EU, EU MDR Cubicdesignz Comments: 0

Staying Vigilant: Best Practices for Post-Market Surveillance under EU MDR

As medical device manufacturers navigate the landscape of post-market surveillance (PMS) under the European Medical Device Regulation (EU MDR), maintaining vigilance and adherence to best practices is crucial. Effective PMS not only ensures ongoing product safety and efficacy but also facilitates compliance with regulatory requirements. Top 7 Key Strategies for optimizing Post-Market Surveillance Here, we outline key strategies for optimizing post-market surveillance in alignment with EU MDR sta...
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