New guidance on technical documentation for IVDs
The European Association for Medical devices of Notified Bodies (Team-NB) has issued a new guidance document on best practices for the submission of technical documentation under the EU In Vitro Diagnostic Medical Device Regulations (IVDR). As Team-NB does not constitute or represent the regulatory authorities, their guidance is not legally compulsory. However, this guidance is likely to help manufacturers to minimise issues with technical documentation during IVDR conformity assessment and therefore speed up the process.
The preparation of technical documentation is a requirement for all in vitro diagnostic devices under the IVDR. For Class B, C and D devices, this technical documentation will be reviewed by an EU notified body as part of the conformity assessment process. Ultimately, the technical documentation should provide sufficient evidence that the device complies with all of the requirements of the IVDR.
Team-NB’s guidance aims to “develop a unified approach on the expectations of technical documentation submissions from manufacturers”. To this end, it provides useful tips on preparing the documentation and advice on common pitfalls to avoid. For example, Team-NB recommends that manufacturers contact their chosen notified body to clarify language requirements for the submission and states that the most common causes for delay are insufficient information and poor organisation.
The guidance then goes on to provide advice on the specific on different types of information that should be included in the technical documentation. This ranges from the instructions for use and performance evaluation report to copies of any subcontractors’ ISO 13485 certificates. In particular, it provides detailed information on the information required for product validation and verification for IVDs, such as accuracy and analytical specificity. There are also specific sections relating to software and cybersecurity requirements.
Ultimately it is the responsibility of manufacturers to read through the regulations and determine exactly what documentation should be submitted for their device Class and type. Nevertheless, Team-NB’s guidance provides a useful starting point for manufacturers looking to tackle this aspect of their regulatory compliance.
How we can help
Regtik, our healthcare regulatory explorer tool, can help you navigate the legal maze by walking your product through a series of simple questions designed to determine whether it qualifies as a medical device and, if so, what class it falls under. It is able to provide results for various jurisdictions (the US, EU, UK and Australia) in one single assessment and can be used multiple times on different versions of your product.
If you are interested in learning more about Regtik or would like to request a demo, please contact any member of our team or register your interest below.
