In-house Production of IVD Medical Devices

Health institutions manufac­turing and using their own IVD/LDT now have increased obligations under the IVDR

With the enforce­ment of the EU IVDR (Regulation (EU) 2017/746), health institutions such as medical laboratories must now also comply with compre­hensive and complex legal require­ments for their in-house IVD medical devices (IH-IVD), often also referred to as laboratory developed tests (LDT). These include the require­ments of ISO 15189 for the quality management system.  

Many institutions wonder why they are suddenly faced with such an exten­sive and complex additional burden, especially since their tests have been in reliable use for a long time. Conflic­ting information adds to the uncer­tainty about what specific steps need to be taken now. Where do you start?   

Added to this is an acute lack of resources: too many other tasks, combined with limited budgets and specialist staff, lead to fears of overwork. And as if that were not enough, many institu­tions are under pressure for not having made sufficient prepara­tions for the upcoming changes.  

Failure to meet the requirements can have serious consequences: In addition to problems with insurance and possible fines, the respon­sible authorities can, in the worst case, remove previously used in-house IVD medical devices from the market and prohibit further use.  

We have made it our task to provide clarity and show health institutions how to meet these challenges. As a partner on their side, we support them in effectively and efficiently complying with the regulations. 

Your all-in-one solution for IVDR compliance: From now on, you can easily face up­coming visits from the authorities

Our team of experts has developed a holistic solution specifically for health institutions. This solution enables them to build up the necessary know­ledge to indepen­dently and efficiently implement the extensive and com­plex require­ments of the IVDR for their devices using suitable templates.

We proceed as follows:

1. Our team first gets an overview of your situation and gets to know your institution and devices in detail.
   
   We identify the relevant regulatory require­ments for you and then define a custo­mized plan for acquiring knowledge and practical implemen­tation.

2. Our experts then start the process of creating your complete and compliant in-house IVD file together with you.
   
   In a series of seminars and workshops (on-site or remote), you will get to know the compo­nents of the in-house IVD file step by step. At the same time, you will practice implemen­ting what you have learned using your own devices as examples.
   
   To do this, you will receive our high-quality and tried-and-tested templates, which you can also use for other in-house IVD medical devices in the future. Our team of experts will regularly review your work and provide you with feedback in follow-up meetings.

3. In the next step, we establish a compliant quality manage­ment system and create audit-proof process descriptions.
   
   In a joint meeting, you will first learn about the specific require­ments for a quality management system (QMS) for IVD medical devices. Based on this, we create a project plan for implemen­ting or expanding your QMS.
   
   We will show you how to efficiently imple­ment the required processes in your company in a series of workshops. Depen­ding on the required process, you will receive suitable templates with which you can work.
   
   ​​​​​​​After creating or adapting your process descriptions, our experienced auditors will conduct an internal audit with you and eliminate any potential non-conformities.