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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.

Checklist 1: Determine Clinical Evaluation Requirements with this Basic Checklist

Checklist 2: Ensure your clinical investigations comply with GCP, a requirement in addition to MDR compliance

Some of the key provisions of the Medical Device Regulations (MDR) include:

Post-market surveillance
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).

Checklist 3: Understand the risk-based approach to a QMS for your clinical trials

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.

Checklist 4: Guidance towards preparation of post market surveillance for medical devices (Part A)

Checklist 5: Guidance towards preparation of post market surveillance for medical device (Part B)

Checklist 6: Check if your PMS is aligned with the latest regulatory requirements for IVDR devices

Checklist 7: Post-Market Surveillance (PMS) plan for medical device manufacturer under EU MDR

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.

Checklist 8: Ensure Complete Reporting on Post Market Clinical Follow-up [PMCF] – A REPORTING TEMPLATE

Checklist 9: How to effectively plan for Post Market Clinical Follow-up [PMCF] – A PLANNING TEMPLATE

Checklist 10: A READY-TO-USE TEMPLATE to report the Post Market Performance Follow-Up [PMPF] – IVD Devices

Checklist 11: Plan Your Readiness for Post-Market Performance Follow-Up [PMPF] – IVD Devices

In addition, improve clinical performance evaluation of IVD Devices with the following three checklists.

Checklist 12: Planning template for Clinical Performance Study for IVD Devices

Checklist 13: Planning framework for Clinical Performance Study for IVD Devices

Checklist 14: Generate a performance evaluation report IVD Devices

Vigilance
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

Checklist 17: A Reporting Template for IVD Device’s Clinical Performance Study

Checklist 18: Template to Evaluate Impact of Changes in Critical Raw Material on Medical Device or Supplier Change Notification

Digitize your clinical compliance with ComplianceQuest’s checklists, guidance documents, frameworks, and templates. Request a demo.

Watch this space for more such checklists and templates.

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