The new IVDR regulation not only poses challenges to the suppliers of the IVD-labels instruments but also to their contract manufacturers. One of the questions that often comes up is: Do we, the contract manufacturers, have to hand over the complete documentation including all the drawings to legal manufacturers (our customers) and thus give away the internal know-how? The platform has been developed by the contract manufacturer after all and made some adaptions – we call it “customization” – to the customer. So, let’s take a look at the IVDR regulation to get an idea what scope of documentation has to be handed over by a contract manufacturer to its customer.
The IVDR expects the legal manufacturer to have access to “Technical Documentation” (TD). The structure and content of TD is defined in the IVDR in Annexes II and III (page 97).
However, Annex II, for example chapter 3.1, states that the TD must contain information ensuring the understanding of the design stages applied to the device. This includes:
“(b) for instruments, a description of major subsystems, analytical technology such as operating principles and control mechanisms, dedicated computer hardware and software
(c) for instruments and software, an overview of the entire system
(d) for software, a description of the data interpretation methodology, namely the algorithm.”
Thus, for example, a description of the essential subsystems is required, but not a complete specification or technical drawings. The same goes for the overview of the overall system. Also for software, a sufficient description of the methodology is required, but not detailed description of the algorithms, i.e. the formulas.
This is what you find in chapter 3.2 when it comes down to production of devices:
“Information to allow the manufacturing processes such as production, assembly, final product testing, and packaging of the finished device to be understood. More detailed information shall be provided for the audit of the quality management system or other applicable conformity assessment procedures.”
Here too, a clear presentation of the manufacturing process is required, but not the working instructions behind it. It is explicitly stated that detailed information should be submitted for the audit if required. An audit of the manufacturer by a Notified Body would then also include the option of auditing suppliers. In this respect, it could be sufficient that the information remains with the contract manufacturer as a supplier of the manufacturer.
Looking at Annex II, one will notice that the TD predominantly requires “descriptions” and “overviews” for the technical information.
Currently, the common interpretation of the IVDR is that a manufacturer (a Private Label Manufacturer) must keep and maintain the Technical Documentation. There is no experience and no legal interpretation of this regulation yet. In this case, the interpretation is up to the Notified Bodies.
Therefore, we recommend each customer to seek consultation of its Notified Body at a very early stage of a project and to clarify what documentation is to be expected.
What are your experiences yet concerning this topic or how do you handle this? Tell us your thoughts and leave a comment.