ISO 14155:2020 and EU AR for CT
ISO 14155:2020 and EU AR for Clinical Trials.
Medical device clinical trials are essential to the regulatory process for obtaining approval to market a medical device in the European Union (EU). The ISO 14155:2020 standard guides on the
- design,
- conduct,
- recording, and
- reporting of clinical investigations carried out in humans to assess the safety or performance of medical devices.
Medical device manufacturers looking to manage and perform a clinical trial in the EU must follow ISO 14155:2020 in addition to the regulatory requirements set out by Medical Devices Regulation (MDR) and the MEDDEV guidance documents.
While there are many aspects related to a clinical trial, one of the essential requirements for Non-EU Medical Device Manufacturers is the mandatory appointment of an EU Authorised Representative.
The European Union Authorised Representative (EU AR) is critical in managing and performing medical device clinical trials in the EU. As the name suggests, the EU AR is the manufacturer's representative to the European Commission, which ensures compliance with all applicable regulations.
Our Non-EU clients enjoy a relaxed journey in the EU as experts at Med-Di-Dia burn the midnight oil to ensure complete compliance with regulatory requirements. Cut to the chase and appoint us as your EU AR!
Once you appoint an EU Authorised Representative, you can relax for a while and focus on other aspects of the clinical trial, as the EU AR will be responsible for the following:
- Finalizing and Approving the Clinical Investigation Plan (CIP): Every Clinical Trial follows a pre-planned strategy and finalizes the Clinical Investigation Plan. The EU AR will begin immediately by reviewing and approving the CIP, which outlines the clinical trial's objectives, methodology, and design.
- Liaise with Ethics committee and competent authority interactions: All clinical trials are subject to approval from the ethics committee and competent authority. Liaising with these bodies can be tedious, as communications with incomplete supporting documents can affect the approval process. The EU AR will efficiently liaise with the ethics committee and competent authority, reducing the risk of dismissal from a clinical trial.
- Identification of investigational sites: Once the CIP is final and approved, the EU AR will responsibly identify appropriate areas with sufficient resources to conduct the study.
- Informed consent process: A clinical trial must undergo a series of consent approvals. EU AR's role is to ensure that the "informed consent process" is carried out appropriately. It includes liaising with the participants and clinical studies team to get informed consent signed by the participants after receiving detailed information about the trial.
- Monitoring the clinical trial: Hiring a dedicated resource in the EU to monitor the trials could prove to be an expensive commitment of resources. With an EU AR, this can be easily outsourced at a nominal cost. The EU AR monitors the trial and ensures compliance with the CIP, ethical principles, and all other applicable regulations.
- Adverse event reporting: Not all clinical trials align with the expected outcome. Some of the trials could have adverse events, and being a Non-EU company, reporting and liaising with such incidents could be challenging. Here, the EU AR steps in as a super savior as it is the responsibility of the EUAR to ensure that adverse events are reported to the competent authority and ethics committee within the required timelines.
Data analysis and reporting: Once the trial is completed, the EU AR is responsible for reviewing and approving the data collected during the trial and ensuring that it is analyzed and reported per the CIP, ISO 14155:2020, and applicable regulations.
An EU AR not only represents your company to the EU Commission but becomes a Risk Partner in helping you reduce exposure to adverse event reporting, constantly contacting the ethics committee and competent authority, and getting informed consent from the participants.
In conclusion, managing and performing medical device clinical trials in the EU requires strict adherence to ISO 14155:2020 and all other applicable regulations. The EU AR plays a critical role in ensuring compliance with these regulations and should be involved in all process steps, from CIP development to data analysis and reporting. Companies should work closely with their EU AR to ensure all regulatory requirements are met, and the clinical trial follows applicable regulations.
Contact our experts and get end-to-end support by appointing Med-Di-Dia as your EU Authorised Representative for Clinical Trials.
Send us an email - mdd@mddltd.com or click on this link to fill an Interest Form - https://mailchi.mp/b74ad5c0e5ff/eu-ar-landing-page
We are here to be your regulatory risk partners for Medical Devices, Diagnostics and Digital Health!
