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EU MDR

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EU, EU MDR September 25, 2025 Cubicdesignz

MDCG 2022-16 Guidance for Authorised Representatives (AR)

Article 11 of the Regulation (EU) 2017/745 on medical devices (MDR) and EU Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) outlines the obligations and responsibilities for the Authorised Representatives (AR). Authorised Representatives (AR) – MDCG 2022-16 Guidance Key points are taken for Authorised Representatives in accordance with the guidance:...
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16Sep 2025
EU, EU MDR, Regulations Cubicdesignz

Article 61 Clinical Evaluation in the EU MDR

Article 61 Clinical Evaluation The MDR reinforces the clinical data and evaluation process (article 61 and Annex XIV), and the manufacturer must confirm the device’s conformity to fundamental health and safety requirements using reliable clinical data and evaluation. The clinical evaluation establishes the device’s safety and capacity to fulfil its intended function. It also evaluates adverse side effects and determines whether the benefit-risk ratio is acceptable. Manufacturers must...
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15Sep 2025
EU, EU MDR admin

Manual on Borderline and Classification of Medical Devices

New guidelines on how to distinguish between medical devices and medical products under the Medical Devices Regulation have been published by a working group of the European Commission (MDR). The new recommendations from the European Medical Device Coordination Group (MDCG) cover “borderline products” that are difficult to classify as either medical devices subject to the MDR requirements or medical products for human use subject to the requirements of Directive 2001/83/EC (MPD) for CE...
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02Sep 2025
EU, EU MDR, General Information, IVD Cubicdesignz

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

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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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30May 2025
EU MDR, Regulations Cubicdesignz

EU MDR Unveiled: What You Need to Know About Medical Device Regulation in Europe

Introduction about Medical Device Regulation in Europe Introducing the Medical Device Regulation in Europe addresses several challenges. It aims to enhance medical device regulation in Europe to ensure a higher level of safety and effectiveness. The need for the MDR arises from various factors, including shortcomings identified in the previous regulatory framework (Medical Device Directives) and the evolving landscape of medical technologies. Rapid technological advancements in the field of medi...
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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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10Mar 2025
FDA, EU, EU MDR, Regulations, USA Cubicdesignz

Software As a Medical Device and Its Clinical Evaluation

As technology advances across all healthcare fields, Software plays a significant role in all products. It is widely integrated into digital platforms serving both medical and non-medical purposes. Medical device software is one of three types of Software related to medical devices. The other two types of medical device software include Software that is an integral part of the medical device (medical device software) and Software used in manufacturing or maintaining the medical device. Software...
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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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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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