The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) 2017/745 has introduced a number of Quality Management System (QMS) requirements for In Vitro Diagnostic (IVD) manufacturers. Most of the self-declared IVDs have now been reclassified. As a result, roughly 80% of all IVDs in the European market will now require a conformity assessment performed by a Notified Body for the device to be granted access to the market. This conformity assessment will include a review of the Technical File as well as the QMS.

While QMS has always been a part of the IVD industry, the new IVDR will require IVD manufacturers to maintain a classical representation of a QMS system if they wish to retain their CE-Mark. Read NAMSA’s previous blog, “EU IVDR: Understanding the New QMS Requirements,” to learn about the four systems that comprise an effective QMS.

Establishing a strong QMS can be a daunting task, especially for small- and medium-sized companies who have limited resources to support the QMS requirements:

 EU IVD Regulations 2017/745 Article 10(8) Requirements include, but is not limited to:

• Design changes
• Process verification/validation
• Production process controls
• Regulatory compliance
• Risk management
• Performance evaluation
• Post-Market Surveillance

For a QMS to maintain compliancy, the corresponding design and manufacture of IVD Devices should abide by the guidelines provided in EN ISO 13485:2016. Many different elements are defined within this standard to meet compliance; however, in opposition to popular opinion, conformity to this standard can be met with minimal effort and with no need to include additional resources to maintain compliance. With a thorough understanding of the requirements, it is possible to create a system which is simple, easily maintainable and adds great value to the company.

It is important to note that the implementation of this standard is proportional to the risk seen for the device—this will be based on risk classification of Class A through Class D for IVDs. This means, as long as requirements are met from the standard, the manufacturer decides how the provisions can be implemented within the company for which an auditor must accept.

NAMSA recommends sticking to three basic approaches while implementing a QMS standard in accordance with the new directive.

1. Apply the standard/directive to your company, not vice-versa.

• ISO 13485:2016 has several requirements that introduce a change in the working practice. However, these changes should be kept to a minimum. We have seen companies create additional measures to stay compliant and this often creates new workflows, creating additional workload for existing resources.

2. Allow the procedures to describe what it is meant for, perform a well-documented gap analysis to address the differences and implement simple measures to stay compliant.

• You will be surprised how much of what you already do in the company can be used as evidence to meet compliance to EN ISO 13485:2016. For example, if you train your staff members, perform staff appraisals from time to time and keep evidence documented in a systematic manner, you are already completing one major clause within the standard.

3. Create simple and manageable working practices.

• It is widely understood amongst auditors that the main areas to find non-compliance is not in meeting the requirements but the ability of the company to meet the requirements set within their own procedures.

In conclusion, abiding by the requirements of the new QMS is an area of considerable concern; however, overstretching the organisations capabilities or organisational setup while attempting to shoe horn a “compliant” system in to the fabric of the company is the basis for continuing non-compliance, over use of company time and inefficiency within the company. The approach presented above can be invaluable for small- and medium-sized IVD manufacturers where resources are tight.

Understanding how to meet the requirements and also keeping in mind the fabric of the organisation is a delicate balance and can be easily achieved with expert understanding of the standard and how to navigate the requirements.