ISO 13485 & MDR INTEGRATED DOCUMENTATION TOOLKIT

As a medical device manufacturer, if you are implementing an ISO 13485:2016 Quality Management System (QMS), you may wonder how the new European Union Medical Device Regulations (EU MDR) affect you, and how your QMS can help with meeting these new requirements. This article will help to explain the relationship between these two requirements.

EU MDR vs. ISO 13485

It is important to note the difference between these two frameworks. The EU MDR is a regulation released by the European Union that dictates what needs to be done by a company that wants to manufacture or import medical devices into the European Union. This regulation includes information on how medical devices need to be marked and certified, along with updates on what information needs to be submitted to the updated Eudamed database, which stores the regulatory information for each medical device. In short, the EU MDR tells you what you need to do to produce medical devices for the European Union market.

ISO 13485, on the other hand, is an internationally recognized standard for creating a QMS for medical device companies anywhere in the world. ISO 13485 requirements can be used by any organization that needs to demonstrate that it produces medical devices and provides related services that consistently meet customer and regulatory requirements. Where the EU MDR applies to companies that sell medical devices in the European Union, ISO 13485 applies to any company throughout the world.

EU MDR Quality Management System

Throughout the EU MDR regulation it is stated that manufacturers need to have a Quality Management System in place. This QMS needs to ensure that all medical devices are covered by the QMS rules, that the devices are used under the appropriate QMS processes, and that a post-market surveillance system is set up and used.

This management system needs to be audited by a notified body, an organization that is designated by an EU member state to do assessments of higher-class medical devices, in order to certify the medical devices that are created using the QMS processes. In order for a medical device to be certified, and have an indicating CE mark, the company must have a QMS in place.

MDR QMS requirements

In article 10 of the EU MDR, the regulation states what needs to be included in a QMS at a minimum. At the very least, the QMS needs to address the aspects in the table below, which are all covered in the ISO 13485 standard. The table shows the EU MDR requirements, and the ISO 13485 clauses that meet each requirement:

Is ISO 13485 mandatory for MDR?

The short answer is no, ISO 13485 is not mandatory for EU MDR compliance. However, the EU MDR regulation requires that you have a QMS in place, even though it does not identify ISO 13485 directly. To assist companies in understanding all of the standards that are applicable for medical devices in the EU, the EU has created a list of harmonized standards, and the ISO 13485:2016 standard is the only QMS standard referenced on this list – therefore, most companies use ISO 13485 to implement their QMS.

What is important to note is that the EU MDR regulation is not trying to replace ISO 13485 as a QMS requirements document. The EU MDR regulation includes certain processes for medical devices that need to be in place, but the ISO 13485 standard is intended to be an all-encompassing set of inter-related requirements that form the internationally recognized best practices for a company that creates medical devices. By using the ISO 13485 requirements to create your QMS, you can ensure that you have a world-class system for your medical devices, but also a system according to the approved QMS standard by the EU.

MDR impact on QMS

So, how does the EU MDR impact a QMS implemented using the ISO 13485 requirements? For the most part, additional records will need to be maintained to meet the EU MDR requirements. For instance, ISO 13485 requires you to maintain a medical device file (clause 4.2.3), which has a minimum list of information to include. However, for the EU MDR regulations, this documentation will need to include all of the information that is stipulated in Annex II of the EU MDR for the medical device technical file. The EU MDR also requires the additional records of post-market surveillance and clinical evaluation. However, the processes you have in place for creating, updating, and maintaining this documentation will largely remain unchanged.

So, to conclude: you need a QMS in order to be compliant with the EU MDR regulations, and, although ISO 13485 is not directly referenced in the EU MDR regulation, this is the only QMS standard listed in the EU list of harmonized standards; therefore, it is indirectly the only reasonable way to implement a QMS according to the MDR. Since ISO 13485 provides a whole system that is devoted to helping you make your quality processes better, this is an additional benefit on top of becoming MDR compliant.