Clinical Investigation under EU IVDR
Clinical Performance Studies under the IVDR – What’s required, what has changed?
General Background
Regulation (EU) 2017/746 (IVDR) requires that a manufacturer has a clear clinical evidence strategy for each in-vitro diagnostic medical device (IVD).
With this strategy, the manufacturer ensures that sufficient clinical performance data is available to demonstrate that the product works as expected for the target population and target user. Clinical evidence must support the intended purpose as well as any clinical claims the manufacturer issues. Such data usually require conducting performance studies.
Whereas information on the requirements on performance evaluation studies was quite limited under Directive 98/79/EC (which even only provided an indirect definition of performance evaluation studies), Regulation (EU) 2017/746 (the “IVDR”) provides much closer information on obligations for performance evaluation studies.
The requirements for conducting clinical performance studies under the IVDR are laid out in articles 56-77 of the regulation. Further information is provided in ISO standards. The original version of the IVDR still referred to ISO 14155 in recital 66 of the regulation, which is the standard providing guidance on clinical trials with medical devices. The corrigendum, however, includes a reference to the newly developed standard ISO 20916 “In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice”. The development of the new standard is helpful because ISO 20916 differs from ISO 14155 in some aspects, e.g.:
- The potential harms and risks to patient or user which are associated with IVD devices are generally related to erroneous results obtained from the device or else from faulty collection procedures and not so much to the device itself.
Performance studies might not require the use of Case Report Forms (CRFs) in cases that do not record clinical data. Data can be recorded by other means in these cases.
Any study undertaken to establish or confirm the performance of an IVD falls within the scope of the IVDR and must be conducted according to the principles of the Declaration of Helsinki. Other research projects, where IVDs are only used as part of a study but do not target the performance of the IVD itself are not covered by the regulation.
The key steps involved in PMCF under the EU MDR include:
Studies covered by the IVDR can be further divided into
- Interventional Studies (i.e. studies “where the test results may influence patient management decisions and/or may be used to guide treatment” [ISO 20916]) or studies that pose an additional risk to the patient or user and
- Non-interventional studies. These performance evaluation studies may be studies with leftover or archived samples.
Depending on the nature of the study, ISO 20916 further specifies the requirements for study conduct.
Generally, written procedures for all study processes required by ISO 20916 need to be in place. The manufacturer also needs to ensure that a device for a performance study complies with the general safety and performance requirements as defined in the IVDR apart from the aspects covered by the performance study, no matter the lifecycle status of the device. If the Study Sponsor itself is not located in the EU, a legal EU representative needs to be in place.
Furthermore, special requirements regarding vulnerable populations are set out in paragraphs 60-62 of the IVDR, even though issues related to the use of vulnerable subjects might not arise for most IVD studies and should be considered on a case-by-case basis.
Essential steps in clinical performance study conduct are:
Key changes that require the manufacturer´s immediate attention:
Support & Training
Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.
Key points
Key changes that require the manufacturer´s immediate attention:
Our Services
Conducting clinical performance studies can be challenging. AKRA TEAM can help fulfilling the legal obligations in a practical and reasonable way. We can help from the initial strategy to certification by mitigating risk and increasing certification success.
Training
AKRA TEAM can provide training on Good Clinical Practice for both Investigators and Sponsors. Please note that such training is part of the qualification performance study personnel needs to demonstrate.
Process and Templates Development
AKRA TEAM can create required SOPs for performance study processes as well as templates for CPSP and other Trial documents.
Gap Assessment
AKRA TEAM offers to review performance study documentation, especially performance study plan and patient informed consent forms and provide a gap assessment.
Implementation
AKRA TEAM can support in performance study design, protocol development, CRF design, informed consent design. Support can also be provided with trial submission at Competent Authorities and Ethics Committees as well as site initiation, study start-up, and close-out activities.
Continuous update of documentation
AKRA TEAM can help with the handling of CPSP amendments as well as preparation of Interim and Final Study Reports.
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