The new In Vitro Diagnostic Regulation (IVDR) is mandatory as of May 26th, 2022.
This regulation attempts to harmonise the EU IVDR on medical devices for in vitro diagnosis with the EU MDRd on medical devices.
The EU IVDR regulates, among other things, performance studies whose purpose is to collect scientific data with the goal of proving the conformity of the devices. This is not confined to the authorisation phase but it extends throughout the life cycle of the device.
According to the new IVDR all medical devices for in vitro diagnosis will undergo a performance evaluation independent of their classification.
Therefore, as a general rule, clinical tests must derive for performance studies and those studies must comply with the norms indicated in the EU IVDR.
The new regulation forces all performance studies used in the performance evaluation of medical devices for in vitro diagnosis to be performed in compliance with ISO 14155.
According to ISO 14155, any tool used in the process of capture and management of clinical data (EDC, eCRF, form tools, etc.) must follow the coming aspects:
- The electronic data capture system must be validated, which means that the entire validation process and system proofs must be documented, as well as the security and access measures, the maintenance plan, backup copies, contingency system recovery plans.
- The system must ensure the traceability, integrity, trustworthiness, consistency and logic of the introduced data.
- It guarantees that changes in data are documented and that introduced data can not be deleted, which is to be equipped with an audit system that allows the audit of all changes performed in the data.
- The system must be equipped with a system that prevents unauthorized access to the data, both for personnel with access to the system and for personnel external to the system.
- The system must have a list of authorized personnel, the level of access of each one of them and log of the changes in such a list which allows the audit of changes in the access to the system at any given time during research.
- It preserves the blinding (if any) in the processes of randomization.
- The system allows data monitoring in a simple and efficient way.
These requirements indicated in the ISO norm can be reviewed by the notified bodies in charge of the approval of the CE marking of the medical device for in vitro diagnosis, and if found not compliant it can result in a non-conformity of the clinical evaluation by the notified body.
What medical devices are obliged to go through the evaluation of a notified body?
According to the In Vitro Diagnostic Regulation (IVDR), devices can be classified in four groups: A, B, C and D. The classification of these devices is based on the risk it presents for patients in case of a device malfunction. Class A corresponds to devices having less risk and Class D to devices with greater risk.
All medical devices grouped in classes B, C or D are obliged to obtain approval by a notified body. The notified body will be in charge of auditing the performed evaluation and to ensure compliance with the norm requirements.
ShareCRF allows you to comply with the regulation.
If you need to collect clinical data for performance studies of an in vitro diagnostic medical device, ShareCRF allows you to comply with ISO 14155 among many other international clinical research norms like: GCP, 21 CRF 11, Annex 11, etc.
ShareCRF simplifies and reduces the time necessary to obtain the CE marking for medical devices for in vitro diagnosis while allowing you to perform post-market clinical follow-ups (PMCF) in a simple and easy way.
Request a free demo with no commitments and discover how ShareCRF can help you.