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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, Regulations Cubicdesignz Comments: 0

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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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, Regulations Cubicdesignz Comments: 0

Importance of Human Translations vs Machine Translations

Human translation Human translations produce accurate results because it involves at least one language expert. Translations, with a human touch to them, are precise because of the in-depth knowledge that translators carry Human translations are done by native speakers of a particular language or people certified in language translations . Therefore, it is culturally diverse, nuanced and is of high quality. However, this high-quality product is expensive. Machine translation Machine transla...
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12Jul 2024
EU, Regulations Cubicdesignz Comments: 0

Implant Cards for Europe

The European Union’s Medical Device Regulation (MDR 2017/745) introduces a new requirement for manufacturers producing implant cards for medical devices. As per EU MDR, implantable devices are any devices, other than the active implantable devices, that are partially or completely implanted into the human body or are used to replace an epithelial surface or the surface of the eye, by clinical intervention, and are meant to stay in place after the procedure. The device that is intended to be pa...
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12Jul 2024
EU Cubicdesignz Comments: 0

EU Classification of Medical Devices with Examples

EU Classification of Medical Devices Around the world, the definition of medical devices varies. Still, generally, a medical device is any instrument, equipment, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related product intended by the manufacturer to be used either alone or in combination for various medical purposes. Medical devices range from low-risk products such as thermometers to high-risk devices such as pacemakers. In the European Uni...
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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, IVD Cubicdesignz Comments: 0

MDCG Guidance on Article 110(3) of the IVDR

MDGC Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR aims to provide clarification on the concept of ‘significant changes in the design and intended purpose’. This article applies to manufacturers of devices that comply with Directive 98/79/EC and is placed on the market or put into operation after the transition period ends on May 26, 2022, irrespective of the involvement of notified body under the IVDD. It is important to note that IVDR...
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12Jul 2024
EU, FDA, General Information Cubicdesignz Comments: 0

Corrective And Preventive Action (CAPA)

“Corrective action” is the immediate address of an issue, whereas “Preventive action” is addressed to reduce or stop the recurrence of the same error from happening again. What is a CAPA? Corrective And Preventive Action consists of a system of procedures to help improvise the non-conformances, undesirable outcomes and even field safety corrective actions of an organisation. Corrective And Preventive Action must include the following steps: CAPA is a time-bound activity. Corrective And P...
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