With regard to the quality management system, point 8 of Article 10 of the EU MDR IVDR Regulation clearly requires that the manufacturer ensure that the necessary processes are in place for the production of the product range to comply with the requirements of this regulation.
If the manufacturer has applied for or is preparing to apply for an MDR IVDR certificate, then mastering the requirements of the quality management system under the MDR IVDR regulation is a must-do homework.
In this issue, based on the experience of system establishment, operation and on-site audit, the author refines the completed MDR IVDR system upgrade cases, and sorts out the key requirements of the quality management system under the MDR and IVDR regulations.
For an accurate and smooth transition to the MDR IVDR Regulation, it is important to ensure that the manufacturer's quality management personnel are fully aware of the quality system processes and procedures, with a focus on the following:
First, a QMS is established in accordance with the applicable requirements of EN ISO13485:2016;
Second, review the applicable MDR IVDR regulations and identify deficiencies in QMS procedures and records.
2.1 The MDR IVDR regulations introduce a number of new management requirements for manufacturers' quality systems:
Regulatory compliance strategy, including: compliance assessment procedures, compliance with significant changes to the devices covered by the system;
Identify the applicable general safety and performance requirements GSPR and explore the process for meeting the foregoing;
the responsibilities of managers;
Resource management, including: selection and control of contractors and subcontractors;
Establish a risk management process in compliance with the MDR IVDR;
Performance evaluation process for compliance with MDR IVDR regulations, including post-market performance tracking PMPF;
Product realization process, including planning, design, development, production, service;
Assign UDI to devices in accordance with MDR IVDR regulations and ensure consistency and validity of information;
establishing, implementing and maintaining a post-market surveillance system (PMS) in accordance with MDR IVDR regulations;
communication with stakeholders such as administrations, Notified Bodies, economic operators, customers, etc.;
Critical incident reporting and on-site safety corrective action processes in alert situations;
management of corrective and preventive actions and verification of their effectiveness;
2.2 The MDR IVDR confirms the need to minimize risk while taking into account the "state-of-the-art" status of the device, i.e., manufacturers need to determine that the device meets the "state-of-the-art" requirements and provide evidence of that as part of their technical documentation.
2.3 Post-market surveillance procedures and activities are also important QMS requirements for MDR IVDR, and the key to compliance with this requirement is that manufacturers have a feedback loop system in place to control and collect user feedback for traceability and updating of risk management documentation to enable effective monitoring of device performance.
Post-market surveillance PMS requirements are one of the biggest changes to the MDR IVDR regulations.
Manufacturers should establish a PMS plan and update it with risk management documents, technical documentation, performance evaluation reports, etc. (PMS plans and PMS reports are also required for all Class A devices).
The following areas need to be supplemented or updated based on post-market surveillance data:
a.Updating the benefit-risk and identifying and improving the risk management described in Chapter 1 of Annex 1;
b.update design and manufacturing information, instructions for use, and labeling;
c.update performance assessments;
d.update security and performance summaries;
e.identify the need for preventive corrective or on-site safety corrective actions;
f.identify and improve device availability, performance, and safety;
g.Provide a basis for post-market surveillance of other devices;
h.Trend reports.