Invitro Diagnostics

Use Kickfile’s systems to become IVDR ready today.

The IVDR May 2022 transition deadline may seem far away, but there is no time to lose. The new regulation brings IVD devices closer to the stringent requirements for other medical devices. While the new regulation should in the end be a positive step forward for the industry, most IVD manufacturers still have a lot of work ahead of them to ensure a smooth transition.

Kickfile have developed systems that can be used to facilitate compliance in two of the areas that will greatly impact many IVD companies and demand attention, namely the following:

More data –you will need to carefully evaluate your existing clinical and performance data. The IVDR will require you to compile a performance evaluation report for each device, and possible also conduct clinical performance studies to collect data.
PMS –there will be a lot more focus on vigilance by regulators. You will need to show that you have a continuous process improvement cycle in place that links to your risk management processes. This includes implementation of a PMPF.

These are the service needed for Invitro diagnostics:

Performance Evaluation

The requirement for a pre-market performance evaluation is already implied by the current in vitro diagnostics directive (IVDD). However, the new EU In Vitro Diagnostics Regulation (IVDR 2017/746) includes explicitly stated requirements clarifying that manufacturers of all IVDs, regardless of classification, shall plan, conduct and document a performance evaluation in accordance with the IVDR. Let Kickfile’s system guide you through the requirements and provide you with a compliant document structure.

Performance evaluation means an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device. According to the IVDR, clinical evidence must support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan.

Whether you are developing a new IVD medical device or need to update your performance evaluation Kickfile’s system provides you with the tools that you need to ensure compliance with IVDR.

Performance Study

The new In Vitro Diagnostics Regulation (IVDR 2017/746) contains considerable detail on the planning and reporting of clinical performance studies. Let Kickfile’s systems provide you with the tools you need to ensure that you have compliant systems in place for your study.

The purpose of clinical performance studies is to establish or confirm aspects of device performance which cannot be determined by analytical performance studies, literature and/or previous experience gained by routine diagnostic testing. This information is used to demonstrate compliance with the relevant general safety and performance requirements with respect to clinical performance. When clinical performance studies are conducted, the data obtained shall be used in the performance evaluation process and be part of the clinical evidence for the device.

The IVDR includes requirements applying to performance studies, including but not limited to; requirements for studies which obtaining specimens poses a particular risk for the subject, requirements for reporting adverse event occurring in a performance study, requirements for performance studies involving vulnerable subjects.

Post-Market Surveillance and Post-Market Clinical Follow-up

The new Medical Device Regulation (MDR 2017/745) places greater emphasis on PMS and PMCF. Whereof the latter shall be understood to be a continuous process that updates the clinical evaluation and shall be addressed in the PMS plan. It is important to note, however, that the requirement for PMCF under the MDR does not necessarily means that clinical investigations will be required in all cases to collect clinical data. Under the MDR, the definition is much broader and related to all type of clinical information.

Kickfile’s system can be used for creating PMS and PMCF plans, reports and other necessary documentation as well as for updating your clinical evaluation documentation.

Post-Market Surveillance and Post-Market Performance Follow-up

The new In Vitro Diagnostics Regulation (IVDR 2017/746) places greater emphasis on PMS and PMPF. Whereof the latter shall be understood to be a continuous process that updates the performance evaluation and shall be addressed in the PMS plan. It is important to note, however, that the requirement for PMPF under the IVDR does not necessarily means that post-market clinical performance studies will be required in all cases to collect safety, performance and scientific data.

Kickfile’s system can be used for creating PMS and PMCF plans, reports and other necessary documentation as well as for updating your performance evaluation documentation.

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