As we step into the month of February, we at Patient Guard are delighted to extend our warmest greetings to you. We hope this newsletter finds you well and thriving in your respective endeavors. As always, we are committed to keeping you informed about the latest developments in the ever-evolving landscape of medical device regulatory affairs and quality assurance.
As we enter the new year, we begin planning for the upcoming year, contemplating the Regulatory and Quality Assurance requirements for Medical Devices and IVDs. In this newsletter, we provide updates from regulatory authorities and standards organizations, aiding in your planning for compliance activities.
The MHRA has unveiled a roadmap for future UK regulatory implementation, offering insights into their thought process on Medical Device and IVD Regulatory activities. The guidance outlines extended timeframes for accepting CE marked medical devices and IVDs in the UK market.
In the EU, it’s crucial to note the deadline for Manufacturers placing CE mark certified Medical Devices on the market. Those not yet transitioning to the EU MDR 2017/745 must have a contract with an EU-approved Notified Body for recertification by May 2024.
As we draw 2023 to a close, we can reflect on the year gone by and look forward to a new year. What can we expect to see in 2024 from a Medical Device and IVD Regulatory perspective?
The EU deadline for ensuring Manufacturers that place CE mark certified Medical Devices on the market that have not yet transitioned to the EU MDR 2017/745 have in place a contract with an EU approved Notified Body for recertification – May 2024
We are hoping to see draft regulation from the UK government on what the new UK medical device regulations will involve, which is expected to be in place by 2025.
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.
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 devices has transformed the way healthcare is delivered, offering more precise diagnostics, improved treatments, and enhanced patient outcomes. In this blog, we will explore the biggest medical device companies in
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.