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Blogs from Patient Guard
Embark on a journey of comprehensive insights and updates within the dynamic landscape of the Medical Device and In Vitro Diagnostic (IVD) industry through Patient Guard’s cutting-edge blogs. Our commitment extends to providing invaluable content that delves into the intricate realms of Medical Device Regulation and IVD Regulation, with a sharp focus on navigating the regulatory landscapes of the United Kingdom (UK), the European Union (EU), and the United States (US).
At Patient Guard, we are not just a source of information; we are your ultimate partner in understanding and maneuvering through the complexities of Medical Device and IVD regulatory requirements, as well as Quality Assurance. Our blogs serve as a beacon, illuminating the latest updates and insights crucial for professionals and organizations operating in these highly regulated sectors.
To elevate your understanding and empower your knowledge, Patient Guard offers complimentary consultations. Reach out to us today, and discover how our expertise can assist you in achieving compliance for your medical devices and IVD products. Our team is dedicated to providing personalized guidance tailored to your specific needs, ensuring a seamless journey toward regulatory adherence.
In addition to our enlightening blog content, we invite you to explore our enriching YouTube channel and LinkedIn page. Here, industry updates and valuable insights come to life through engaging multimedia formats. Furthermore, our sister website, QMSREGS.com, stands as a comprehensive resource, offering a diverse range of training courses and Medical Device and IVD templates. This integrated approach ensures that your regulatory needs are not only met but exceeded.
Patient Guard is not just a repository of information; we are your ally in navigating the ever-evolving landscape of Medical Device and IVD regulations. Join us on this educational journey, where compliance meets excellence.
Commercialising your medical device or IVD first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market strategies.
Depending on where you plan to sell your device(s), successful registration may involve a substantial effort to meet premarket technical and clinical submission requirements or leveraging your existing registrations and approvals to gain faster access to new markets.
Planning for the design and development of a medical device is a requirement of regulatory systems. All manufacturers of Medical Devices are required to maintain a Quality Management System, in the USA this is determined under the CFR Title 21 part 820. Within the European Union, it is placed within demonstrating certificated compliance with international standard EN ISO 13485. The USA has recently indicated that they will also use the ISO 13485 standard for the requirements of manufacturers being compliant for QMS purposes.
The CE marking of medical devices and in vitro diagnostic devices (IVDs) is a requirement of EU regulations (EU 2017/745 for medical devices and EU 2017/746 for IVDs) to lawfully place medical devices on the EU market. Manufacturers must affix the CE mark on the medical device or IVD itself and on the primary packaging (or just on the packaging if affixing to the device itself it not possible). The CE mark should also be placed on any instructions for use and any labelling. The use of the CE mark identifies that a medical device or IVD conforms to EU regulatory requirements and is a symbol that a device meets safety standards.
A medical device technical file is a concise set of documents created by a manufacturer to explain the performance and safety of a particular Medical Device in a clear, well-organized, easily searchable, and unambiguous manner.
In order to prove compliance with the general safety and performance criteria of the legislation, the manufacturer must have – and keep up-to-date – this technical documentation, regardless of medical device class.
Post-market surveillance (PMS) is a pivotal aspect that governs the continued monitoring and assessment of medical devices after they have entered the market. Across the EU, UK, and USA, distinct regulatory frameworks shape PMS protocols, fostering safety, and innovation simultaneously.
Standards relating to medical devices are continually being updated and reviewed to ensure that they follow the most up to date thinking on safety and performance relating to the standards specific subject matter. Following medical device standards is a way of demonstrating that medical devices placed on the world market are safe effective and state of the art. All medical device regulations worldwide require manufacturers of medical devices to apply safety standards relevant to their medical devices.
The EU Commission has recently announced that the transition period for completing and implementing EUDAMED has been extended again. The previous target for full functionality was the second quarter of 2024. The new target date for this is now the second quarter of 2027.
The EU Authorised Representative – Medical Devices, how the role has changed since the introduction of the MDR & IVDR
The EU Authorised Representative role for medical devices has existing since before the introduction of the Medical Device and In Vitro Diagnostic Regulations (EU MDR 2017/745 and EU IVDR 2017/746) were introduced in 2017 and was a requirement of their predecessors the medical device directives.
Since the MDR and IVDR Regulations were introduced the role of the EU Authorised Representative has become wider in scope and responsibilities.
Manufacturers who are not registered businesses in the UK but wish to place medical devices or In Vitro Diagnostics (IVDs) on the UK market, are not allowed to do so without having in place an agreement with a UK registered organisation. This organisation is the UK Responsible Person, and represents and registers the manufacturers medical devices and IVDs with the Medicines & Healthcare products Regulatory Agency (MHRA).
Navigating the EU 2017/746 In Vitro Diagnostic Regulations: A Comprehensive Guide for Compliance and Patient Safety
In the ever-evolving landscape of healthcare, in vitro diagnostic (IVD) devices are indispensable tools, providing invaluable insights into patients’ health conditions. With the introduction of Regulation (EU) 2017/746, commonly known as IVDR, the European Union has implemented stringent regulations to ensure the safety, efficacy, and quality of these diagnostic instruments. As of May 26, 2022, this regulation has ushered in a new era, shaping the practices of manufacturers, healthcare professionals, and patients as they navigate the complexities of this comprehensive regulatory framework.
In the realm of healthcare, ensuring the safety and efficacy of medical devices is paramount. Patients rely on these devices for diagnosis, treatment, and improved quality of life. Biological evaluation plays a pivotal role in determining the biological safety of these devices. Governed by international standards, most notably the ISO 10993 series, biological evaluation involves a thorough assessment of a device’s interaction with living tissues. This blog delves into the importance of biological evaluation, highlighting the critical biological endpoints outlined in ISO 10993, the significance of a robust biological evaluation plan, and the crucial role of qualified experts in this process.
In the ever-evolving landscape of healthcare technology, medical device software plays a pivotal role in patient care. To ensure the reliability, safety, and effectiveness of these software-driven devices, regulatory standards are in place. One such crucial standard is the IEC 62304. In this blog, we will delve into the intricacies of IEC 62304, exploring its significance, key concepts, and its impact on the development of medical device software.
In the ever-evolving landscape of healthcare, the development and deployment of cutting-edge medical devices have become indispensable. With advancements in technology, the need for stringent regulatory and quality assurance services has never been more crucial. In this dynamic environment, medical device consultancy plays a pivotal role, guiding innovators through the complex web of regulations, ensuring compliance, and facilitating the delivery of safe and effective devices to patients worldwide.
In the fast-paced world of medical device manufacturing, regulatory standards are the bedrock of patient safety and product quality. Recently, the European Union has taken a significant step by extending Article 120 of the EU Regulation 2017/745 and EU Regulation 2017/746. This move has been made to address the mounting backlog of CE mark certifications and re-certifications within notified bodies, the entities responsible for ensuring that medical devices meet stringent quality and safety requirements before they reach the market. In this blog post, we’ll delve into the implications of this extension for medical device manufacturers and emphasize the critical importance of continued compliance.
In today’s fast-paced and highly competitive business environment, ensuring the quality of your Medical Device products and services is paramount. Professional Quality Assurance (QA) support is the unsung hero that can help your business thrive. Whether you’re a start-up or an established enterprise, effective QA support can make a significant impact on the quality of your Management System and Devices. In this blog post, we’ll explore how professional QA support can benefit your business.
In the realm of healthcare, artificial intelligence (AI) is not just a buzzword; it’s a transformative force that is reshaping the landscape of medicine and medical technology. Over the past decade, we have witnessed remarkable advancements in AI, and its impact on the medical device industry is nothing short of revolutionary. As we step into the next five years, the synergy between AI and medical devices is poised to usher in a new era of healthcare innovation, efficiency, and patient outcomes.
In the world of medical devices, ensuring both safety and compliance with industry standards is paramount. One such crucial standard is ISO 14971, a guideline that outlines the application of risk management to medical devices. In this blog post, we will delve into the significance of ISO 14971 in medical device compliance and explore how tools like Patient Guard can aid in achieving and maintaining compliance with this essential standard.
In an era marked by unprecedented advancements in healthcare technology, the medical device industry stands as a beacon of innovation. The development of cutting-edge medical
In today’s rapidly evolving healthcare landscape, ensuring the safety and effectiveness of medical devices is of paramount importance. To address this, the European Union (EU)
A vital starting point and manual for the clinical evaluation of your medical device is the Clinical Evaluation Plan, or CEP. Find out more about this important document’s needs.
Medical Device Start-up – is not applying a regulatory strategy early on costing more in the long run?
Starting a medical device company can be a stressful time, what with design and development activities, finding funding, ensuring you don’t run out of capital etc.
One very important area that is often not considered early enough is the regulatory side. Many medical device startup companies think that the regulatory activities don’t begin until the device has been developed and they often don’t realise the cost involved in ensuring that the medical device meets the safety requirements of the medical device regulations globally
Medical devices are essential pieces of equipment, and there are a lot of them out there on the market. In this blog, we’re looking at
We publish a monthly news letter with news updates relating to the Medical Device and IVD Industry. This includes general regulatory and Quality Assurance news updates in the USA, EU and the UK. It also includes updates to any regulations, MDCG guidance documents, MHRA guidance documents and FDA guidance documents. Importantly it also includes any updates to Medical Device and IVD related ISO standards.
Subscribing to our news letter is easy, all you have to do is scroll down the page to the subscribe to our newsletter section and enter your name and email. The newsletter is issued at the beginning of each month.
Keeping up to date with the latest standards and guidance is important as a medical device manufacturer to ensure that your medical devices remain in compliance.