The new European Union Medical Device Regulation is mandatory as of May 26th, 2021.
Such regulation dictates, among other things, the process to be followed for medical devices to acquire the CE marking, besides the obligations of medical devices manufacturers once the CE for their device has been obtained. According to the Medical Device Regulation (MDR), all medical devices must be clinically assessed, independent of its classification.
The goal of this clinical evaluation is to prove the safety and performance, and also the positive risk-benefit ratio of a medical device. This is accomplished by performing a critical and objective evaluation of the clinical data.
Clinical data upon which the analysis is performed can be obtained in two ways:
- Clinical research performed on the medical device in question
- Through available public data, such as data published in scientific literature or data from comparable medical devices.
In this article we will focus on the first one: clinical research, and what things are important to consider when collecting clinical data in such research via an electronic data capturing (EDC) system.
The new regulation compels that all clinical research used in the clinical evaluation of the medical device, whether pre-market or post-market clinical follow-ups (PMCF), must 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 consider the following 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, 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 Medical Device Regulation, there are 4 classes in which a medical device can be classified; I, IIa, IIb and III. This classification is performed based on the potential risk each device presents for the person using it, being class I assigned to devices with less risk and class III to those with greater risk.
All medical devices classified as class IIa, IIb or III are obliged to obtain approval from a notified body, that means that it is required that a certified third party audits the evaluation process they have undergone. Devices class I can self evaluate with no need of obtaining approval from a notified body, although there are some exceptions that compel certain class I medical devices to be approved by a notified body.
ShareCRF allows you to comply with the regulation.
If you need to collect clinical data that will help in the process of clinical evaluation of your medical device, ShareCRF allows you to comply with ISO 14155 among many other international clinical research regulations: GCP, 21 CRF Part 11, Annex 11, etc.
ShareCRF simplifies and reduces the time necessary to obtain the CE marking for medical devices 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.