Why Industry 4.0 Needs Quality 4.0 for EU MDR?

Why Industry 4.0 Needs Quality 4.0 for EU MDR?

Author Stefan Horneborg

“Don´t hesitate, innovate!”
“Regulation: Don´t hesitate, innovate!” was the slogan at this year’s MedtecSUMMIT in Germany and specialists gave their input for the new EU MDR regulation and how to overcome this new regulation.
Because Industry 4.0 is already a practice which is under implementation in all industries and digitalization drives more innovation into the market, in several areas technology like 3D printing, advanced robotics, Wearables, augmented reality (AR), and virtual reality (VR), The Internet of Things (IoT), The Industry Internet of Things (IIoT), Artificial intelligence is the new standard and leads to Smart Manufacturing!
Now the industry needs to connect, integrate, and align the 4.0 with Quality 4.0 which is core for the EU MDR regulation where still MedDevice Manufacturer struggling to have a QMS in place which fulfills the new regulation. Of course, there is a relationship between EN ISO 13485:2016 (Medical devices. Quality management systems. Requirements for regulatory purposes) and European Medical Devices Regulation (EU MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). This relationship can be evaluated in the Guidance CEN/TR 17223:2018.

What you need to know!
But what you need to know about the change of the medical devices legislation and how you can prepare for this is not that complicated.
There are several steps that you should process, assess, analyze, review, implement, execute, and monitor!
So, you need to consider organizational challenges, and the management needs to be aware and to understand the importance of the business implications of the MDR! Make clear assessments on the products, internal resources of the organization, and budgeting! Review of the changes needed to the existing technical documents (Technical files) and you should review and upgrade or change your existing quality management system (QMS). This means your QMS should have a strong document control area to meet standards and processes for medical devices under the new regulation and you need to build new regulatory requirements into the QMS and identify/hire a responsible person for regulatory compliance within your organization (EU MDR Article 15) who is adequately qualified and trained and document the training and certificates in your QMS in your Training Management space!
According to Article 10 of the EU MDR, you now need to have the Risk Management system/process which can be part of a quality management system, for example, one that is based on ISO 13485:2016, but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019.
A completely new feature of the Regulation is the system of unique device identifiers (UDIs) (Article 27) which will enhance the traceability (Article 25) of MD’s. You need to have a system in your QMS which will let you track the UDI’s in any lifecycle stage! Product manufacturers shall keep the technical documentation available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the Union market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the Union market.
Management of changes is another important piece in the regulation. Because you should ensure that, as part of your Quality Management System, the label printing process is verified and validated, and the equipment is used and maintained in accordance with the relevant procedures. Changes to validated processes need to be assessed for the impact a device labeling, the software used in implementing the UDI system, should be in a validated state in accordance with relevant procedures, so validation/verification is important here as well!
Of course, you should as well investigate existing purchase activities and their controls to identify materials and equipment which may have an impact on the compliance of the UDI system. You need to investigate to identify parts, materials, equipment that are placed as a device Articles 16(1), 17(2), 22(4), or 23(2) MDR, which means there should be a Supplier Management system as well in your QMS!
There are lots of other records which need to be linked to the UDI. So, you must ensure for example that the UDI is Linked between the UDI and a Complaint record or to the service records which means your QMS should provide a Complaint Management as well.

Another big point is the process Documentation, which means you should have reporting capabilities in your QMS for different Methods like Control charts, flowcharts graphical, or written instructions.
The best practice here is to have a Dashboard report available to extract all needed documentation available!

As a recommendation to get in line with the EU MDR regulation and upcoming new regulations you should use the process approach which is key for an effective QMS! If you are already in line with ISOP 13485 there is less work for the EU MDR compliance!
This means you need to break down the company into processes and determine their sequence, interaction, inputs, and outputs.
ISO 13485 covers already lots of requirements from the EU MDR regulation. For example, The requirements for Risk Management in the EU MDR QMS requirements are covered by clause 7.3 in ISO 13485, and requirements for CAPA (with verification of effectiveness) are covered by clauses 8.5.2 and 8.5.3. This shows that ISO 13485 helps you already a lot with covering the regulations from the EU MDR!
With Intellects QMS you will be able to cover the EU MDR and all needed ISO regulations and you will be ready for future regulations!

You can contact our team or request a free demo.

What’s Next?
Now that you have learned about the Reason Why Industry 4.0 Needs Quality 4.0 for EU MDR, learn about the benefits of ISO 14001.