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EU MDR

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

Ensuring Compliance and Quality: The Role of CE Marking in Safeguarding Patient Safety

The CE marking signifies a medical device’s adherence to stringent European Union (EU) safety regulations. This compliance process, known as CE marking compliance for patient safety, is critical in ensuring the quality and effectiveness of medical devices. By mandating rigorous assessments, it directly impacts patient safety. Manufacturers must demonstrate their devices meet essential safety and performance requirements, minimizing risks associated with malfunction, biocompatibility issues...
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12Jul 2024
EU, General Information Cubicdesignz Comments: 0

Directive (EU) 2019/904 on the reduction of the Impact of certain Plastic Products on the Environment

Introduction Directive 2019/904 aims to mitigate the environmental and health impacts of specific plastic products, particularly in aquatic environments, while fostering the transition towards a circular economy through innovative and sustainable practices. It encompasses single-use plastic items outlined in the Annex and products made from oxo-degradable plastic and plastic-containing fishing gear. Member States are mandated to implement measures to significantly reduce the consumption of singl...
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05Feb 2024
EU, Regulations admin Comments: 0

EU MDR – Article 117

EU MDR – Article 117 – The French Poly Implant Prostheses (PIP) breast implant controversy prompted medical rules to be revised and formed new Medical Devices and In-Vitro Devices Regulations to safeguard public health. As per the European Medicines Agency (EMA) definition, a medicinal device is a substance or combination of substances intended to treat, prevent or diagnose a disease, or restore, correct or modify physiological functions by exerting a pharmacological immunological...
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05Feb 2024
EU, Regulations, Swiss, UK, USA Cubicdesignz Comments: 0

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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05Feb 2024
EU, Regulations Cubicdesignz Comments: 0

Regulatory Pathway for Clinical Investigation in the EU

Regulatory Pathway for Clinical investigation creates a set of clinical data that is crucial to understanding the effectiveness of a medical device. Clinical Investigation is done for previously CE marked devices or for research medical devices. Clinical Investigation is governed by a clinical investigation plan with an objective, methodology, and record keeping. Top 5 Steps involved in Clinical Investigation Step 1 Appointment of a Representative- Appoint a legal representative....
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05Feb 2024
EU, Regulations Cubicdesignz Comments: 0

Annex XVI – EU MDR

What is an Annex XVI product? Annex XVI products are those for which a manufacturer claims only an aesthetic or another non-medical purpose but are like medical devices in terms of functioning and risk profile. These categories of products were added in the new Regulation to establish production and surveillance standards for these previously unregulated products to protect users’ health and safety. LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE REFERRED TO IN ARTICLE 1(2) When...
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05Feb 2024
EU, Registrations, Regulations Cubicdesignz Comments: 0

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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