The regulations governing medical device and in vitro device manufacturing industries are aimed at improving product quality, patient safety, and process improvements. In an ever-changing regulatory environment, keeping track of the changes and modifying processes to remain compliant can be a challenge.
A recent, impactful change is that of the European Union’s Medical Device Regulations and In Vitro Device Regulations. The new regulations aim to better align the EU legislation with rapid technological advances, changes in medical science, and progress in law-making. Enabling lifecycle management and continuous evaluation of medical device products, the new regulations aim to improve clinical safety as well as create fair market access for manufacturers from around the world.
The various checklists highlighted in this post, will certainly help you streamline the overall regulatory and compliance process. The first two checklists (below) offer a quick guide to get started.
Some of the key provisions of the Medical Device Regulations (MDR) include:
Manufacturers have to create post-market surveillance (PMS) system plan for each of their products based on the risk class and the type of device. In addition to its implementation, the PMS has to be documented, maintained, updated and integrated with the Quality Management System (QMS).
The PMS system provides manufacturers with records and analyses data on the quality,
performance, and safety of the device throughout its entire lifetime.
ComplianceQuest provides an in-depth checklist that can help medical device manufacturers establish a systematic ongoing procedure to collect, review and analyze the experiences gained from devices already placed in the market in the post-production phase. Further, it helps in evaluating whether there is sufficient evidence to confirm compliance with relevant general safety and performance requirements when the device is being used according to the manufacturer’s instructions for use or generally recognized modalities of use.
Manufacturers also need to incorporate a post-market clinical follow-up plan (PMCF) and post-market performance follow-up (PMPF) for medical and in vitro devices. Here are some checklists related to those.
In addition, improve clinical performance evaluation of IVD Devices with the following three checklists.
Checklist 14: Generate a performance evaluation report IVD Devices
The new regulations require centralized recording and evaluation of device recalls or reporting of events by competent authorities. These are called serious incidents and may cause the death of a patient or user or serious deterioration. Manufacturers are also required to report such events without delay. Additionally, it is critical that medical devices manufacturers notify any changes related to critical raw materials used or when a supplier is changed.
Checklist 15: Vigilance Reporting and Monitoring
Checklist 16: Comprehensive Guide for Establishing a Vigilance System
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Watch this space for more such checklists and templates.