Class I Medical Device Manufacturers Need an established QMS Under the New MDR

By Sofie Petersson

Senior Quality and Regulatory Advisor and Acting Quality and Regulatory Manager, Management Representative and PRRC in Medical Device Industry.

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While Class I devices are typically considered low-risk and allow self-certification without involving a notified body, the Medical Device Regulation (MDR) has introduced some new but mainly clearer requirements that manufacturers need to be aware of. These changes aim to ensure the safety and efficacy of all medical devices across the EU market, regardless of their risk classification.

Under the new MDR, Class I medical device manufacturers in the EU are required to demonstrate compliance with the regulation, which includes having a Quality Management System (QMS) in place. Read on to find out more about these requirements and how they impact your business.

What are the most important regulations in MDR for Class I devices?

Under the previous Medical Device Directive (MDD), Class I devices had requirements regarding QMS and technical documentation, however the requirements have since been clarified and new requirements introduced with the MDR, which replaced the old MDD in May 2021. The most important regulations include the need for Class I manufacturers to:

Establish, document, implement and maintain a QMS in line with the requirements of the MDR
Prepare technical documentation for the device
Conduct and document clinical evaluation
Implement a post-market surveillance system
Report serious incidents and field safety corrective actions

Why Class I medical device manufacturers need a QMS

Class I devices are typically considered low-risk, but the MDR requires their manufacturers to have a QMS in accordance with their role stated on their declaration of conformity.

A QMS is a formal system that documents processes, procedures and responsibilities for achieving quality policies and objectives. For medical devices, a QMS helps ensure that devices are safe and effective and meet all applicable regulatory requirements.

Implementing a QMS helps you:

Ensure the safety and performance of your devices
Identify, address and control potential risks and issues before they become problems
Demonstrate compliance with regulatory authorities
Continuously improve your products and processes

MDR Article 10 states all these general obligations of medical device manufacturers and more specific the section 9 spells out a clear list of what the quality management system (QMS) shall contain.

CE marking: More than just a label

Class I medical device companies typically manufacture products with the lowest risk profile such as non-invasive tools, simple aids, and even weighted duvets marketed for medical use. Using the CE mark on these products signifies that they meet the EU regulation (MDR) for medical devices. This is crucial for legal compliance and gaining access to the broader EU market, including state healthcare systems.

A misconception among Class I device manufacturers is that CE marking is a simple matter of labelling. In reality, obtaining a CE mark, especially under the MDR, involves demonstrating compliance with the regulation’s safety and performance requirements. This process includes having a QMS in place, conducting a clinical evaluation and ensuring that all necessary technical documentation is in order.

The benefits of an eQMS

Having a QMS is not just a legal requirement under the MDR. It’s also a good business practice that can help you ensure the safety and effectiveness of your devices, which ultimately protects your patients and your reputation.

An eQMS, like MedQdoc, offers a streamlined, digital approach to managing quality processes. For Class I companies, this means an accessible, efficient way to maintain compliance with MDR requirements without the overhead of a more complex QMS.

With MedQdoc, Class I manufacturers can:

Access pre-built templates and workflows that are specifically designed for medical devices and the MDR
Easily create and manage their clinical evaluation reports, risk management files and other required technical documentation
Collaborate within a team and share information securely in the cloud
Grow and evolve their business using a QMS that scales with them

MedQdoc also provides a range of other features that can help all medical device manufacturers manage their QMS more effectively, such as:

Document control and version management
Training management
CAPA management
Change management
Risk management
Complaint handling and vigilance reporting
Supplier management

Non-compliance can have serious consequences

Compliance with the MDR’s requirements for Class I devices, including the need for a QMS, is not optional. As a manufacturer of Class I medical devices sold in the EU, you are legally obligated to comply with the MDR, even if you don’t need to involve a notified body. Non-compliance can result in serious consequences, such as product recalls, legal action, substantial fines and damage to your reputation.

Competent authorities in Europe are aware that Class I companies have a history of not being in compliance with MDD and have since the introduction of MDR started to audit Class I manufacturers more frequently.

Implementing a QMS is critical in ensuring compliance with the MDR and protecting your business. An eQMS like MedQDoc can streamline this process, making it easier and more efficient to manage your quality processes and maintain compliance with the regulation. See how MedQdoc can help you meet regulatory requirements while saving you time and money by booking a demo with us today.