Understanding the Medical Device Regulation (MDR) Audit Process: A Comprehensive Guide
The Medical Device Regulation (MDR) audit process is a crucial step in ensuring that medical devices meet the highest standards of safety and performance. As of May 2021, all medical device manufacturers, importers, and distributors must comply with the new MDR regulation in Europe, which replaces the previous Directive 93/42/EEC.
The MDR audit process involves an independent third-party auditor evaluating a companys Quality Management System (QMS) to ensure it meets the requirements of Regulation (EU) 2017/745. This regulation aims to improve the safety and performance of medical devices, as well as provide greater transparency in the supply chain.
In this article, we will delve into the MDR audit process, providing a detailed overview of the key steps involved, including preparation, on-site audits, and follow-up activities. We will also examine two critical aspects of the audit process: certification and post-market surveillance.
Preparation for the MDR Audit
Before an auditor arrives at your premises, its essential to be prepared. This involves several preparatory steps:
Review of the QMS: Familiarize yourself with the MDR requirements and review your companys Quality Management System (QMS) to ensure it meets all the necessary standards.
Documentation: Ensure that all relevant documentation is up-to-date, including technical files, user manuals, and labeling instructions.
Employee Training: Provide training for employees involved in the production and maintenance of medical devices on MDR requirements, QMS, and relevant regulatory procedures.
Mock Audits: Conduct mock audits to identify potential issues and improve your companys readiness.
Key Aspects of the Audit Process
The audit process involves several critical steps:
Introduction and Explanation: The auditor will introduce themselves and explain the purpose of the audit, as well as outline the scope of work.
Audit Preparation: Review your companys QMS and documentation to identify areas that need improvement.
On-Site Audit: Conduct a thorough review of all relevant documents and records, including technical files, user manuals, and labeling instructions.
Certification: The auditor will verify if your company meets the MDR requirements for certification.
Certification
Certification is an essential part of the audit process. A Notified Body (NB) must be involved in this step:
Notification: Inform the NB about your intention to apply for MDR certification.
Application: Submit an application for certification, including all required documentation and evidence.
Audit Planning: Work with the NB to plan the audit process, including dates, duration, and scope of work.
Post-Market Surveillance
Post-market surveillance is a critical aspect of the MDR regulation:
Surveillance Plans: Establish a post-market surveillance plan that outlines the actions you will take in case of adverse events or device malfunctions.
Record Keeping: Maintain accurate records of all post-market activities, including adverse event reports and complaints.
QA Section
Here are some additional details about the MDR audit process:
Q: What is a Notified Body (NB)?
A: A Notified Body is an independent third-party auditor that evaluates a companys QMS to ensure it meets the requirements of Regulation (EU) 2017/745.
Q: How do I choose a NB?
A: Choose a NB based on their reputation, experience, and expertise in medical device audits. Research the NBs certification process, fees, and turnaround time for audit reports.
Q: What documents do I need to provide during an MDR audit?
A: Provide all relevant documentation, including technical files, user manuals, labeling instructions, and quality records.
Q: How long does a typical MDR audit last?
A: The duration of an MDR audit can vary depending on the size and complexity of your company. However, it typically lasts between 3-5 days.
Q: What happens if I fail to meet MDR requirements during an audit?
A: If you fail to meet MDR requirements, the auditor will issue a non-conformity report outlining the areas that need improvement. You will have time to address these issues before re-auditing.
Q: How often do I need to conduct post-market surveillance activities?
A: Conduct post-market surveillance activities regularly, including quarterly or annually, depending on your companys specific needs and circumstances.
The MDR audit process can seem daunting, but with proper preparation and understanding of the key steps involved, you can ensure a smooth and successful audit.
