Clinical Investigation
What’s required for the most suitable clinical investigation strategy?
Clinical investigations under the EU Medical Device Regulation (EU MDR) refer to the process of conducting clinical investigations to collect data on the safety and performance of medical devices before they are placed on the market. This may also include significant changes and initial CE marking under EU MDR where clinical investigation data is deemed necessary to address gaps in clinical evidence. These investigations are an important part of the EU regulatory process and are required for certain classes of medical devices to ensure that they meet relevant safety and performance standards.
With the EU MDR clinical investigations are more important than ever. Especially since conformity assessment based on equivalence is often no longer possible, medical device manufacturers must collect clinical data on their own device(s) in order to achieve successful conformity assessment.
For class III devices and implantable devices data should generally be sourced from clinical investigations that have been carried out under the responsibility of a sponsor. This also applies to lower class devices that have a new intended use or incorporate new technologies that raise safety or other concerns. EU MDR requires that clinical investigations be conducted for devices that raise safety concerns or have a high degree of innovation, regardless of their classification.
Before conducting a clinical investigation, the sponsor of the study must obtain approval from the relevant Competent Authority in the EU member state where the investigation is to take place. The sponsor must also obtain ethical approval from an Ethics Committee, which is responsible for reviewing the study protocol to ensure that it is ethically sound and that the rights and safety of study participants are protected.
Clinical investigations under the EU MDR must be conducted in accordance with Good Clinical Practice (GCP) guidelines, which provide a set of international standards for the design, conduct, and reporting of clinical trials. The guidelines aim to ensure that clinical trials are conducted in a way that protects the rights, safety, and well-being of study participants, and that the data generated is reliable and can be used to support regulatory decision-making.
Once a clinical investigation has been completed, the sponsor must prepare a clinical investigation report (CIR), which summarizes the results of the study and provides conclusions on the safety and performance of the medical device. The CIR is then submitted to the Competent Authority for review as part of the conformity assessment process.
Planning and conducting a clinical investigation accordingly are often resource intensive and dependent on the applicable type of Clinical investigations different requirements have to be addressed (See flowchart). Akra Team can support you in your effort to design and plan a clinical investigation reasonably.
Key Points:
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Align your clinical investigation strategy with your marketing strategy: What are the product claims you plan to make and which data support them?
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Generate enough data to get your stakeholders trust in the safety and performance of your device.
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Make sure to consider your risk management data when planning your clinical investigation outcome parameters.
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Consider reimbursement requirements within your market and regulatory requirements of other potential target markets.
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Confirm that your QMS system is covering your clinical investigation, even if some activities are outsourced.
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Apply country specific requirements for clinical investigation application and documentation.
Our Service
Process and Templates Development
Gap Assessment / Guidance
Implementation