Our services cover the entire life cycle of medical and IVD devices. Please select one of them to review the specific life path and related tasks.
Life path of a medical device
- Exploration of state-of-the-art; a critical summary of the literature of the relevant medical field
- Risk classification of the device
- Design and development in the light of requirements of the state-of-the-art & literature knowledge
- Establishment and maintenance of a quality management system from the very beginning of the design & development throughout the entire life cycle
- Simultaneously outlining the structure of the technical documentation
- Creating a general requirement checklist
After the production of the first prototype:
Tests based on harmonized standards, common specifications, or other, unspecified tests, such as:
- Biocompatibility tests according to ISO 10993-1 requirements
- Application of usability engineering to medical devices according to IEC 62366-1:2015
- Electrical safety tests according to the requirements of the IEC 60601 family of standards, if applicable
- Verification of product-specific standards and their requirements, if applicable
In parallel with the preclinical tests, and based on the results of the tests:
- Compilation of the first draft of the Instruction For Use
- Compilation of the first draft of the Risk Management File
- Identification of relevant and specified clinical outcome parameters
- Clinical development plan from the first human trial to post-marketing clinical follow-up, with creating the following corresponding plans:
- Pilot studies
- Confirmatory studies
- Post-marketing clinical follow-up (PMCF)
Pilot study(-ies):
- Its purpose is to answer questions of which the literature does not provide sufficient information, and to collect preliminary data for confirmatory studies
- For example, a pilot study may collect data to determine the sample number of a confirmatory study
- Based on its results, further planning and development of the device may be required
- It typically has a low patient count, with a short-follow-up model
Confirmatory study(-ies):
- It aims to collect justifying evidence from a clinical environment that demonstrates the device's compliance with the relevant general requirements.
- Based on the pilot study results and/or the Clinical Evaluation Plan, planning a confirmatory study requires, among others, the following steps to verify the clinical outcome parameters:
- Setting up a hypothesis
- Defining primary and secondary endpoints
- Determining the sample number
- Defining inclusion and exclusion criteria
- Accurate description of trial events
- Compilation of a statistical plan
- Defining a monitoring plan
- The results of confirmatory studies are crucial for the demonstration of clinical conformity, and thus for the compilation of the Clinical Evaluation Report.
Tasks related to clinical trials, briefly:
- Compilation of the Clinical Investigation Plan (CIP) based on MDR and ISO 14155
- Compilation of the Investigator’s Brochure (IB) based on MDR and ISO 14155
- Compilation of additional essential documentation for the study
- Conduct feasibility study(-ies) in the participating countries
- Obtaining Regulatory approvals (Competent Authority and Ethics Committee)
- Conducting the clinical trial
- Data collection and evaluation
If all the preclinical and clinical data, Risk Management File, label, Instruction For Use etc., that is, every element of the Technical File is available, then the Clinical Evaluation Report [CER] can be compiled to finalize the technical documentation.
- In the case of most Class I devices, manufacturers must register at Competent Authorities and in EUDAMED, issue the Declaration of Conformity and start the marketing
- At higher risk categories, manufacturers must submit the technical documentation to a Notified Body for a conformity assessment procedure
- After a successful conformity assessment & certification, distribution can be launched
- Post-market surveillance both in the market and in the clinic
- Real-life data collection based on PMS and PMCF plans.
- PMS data:
- Sales data
- Complaints (non-clinical)
- Marketing data
- PMCF data:
- Data on the clinical safety and/or performance of the device from the clinic and the literature
- Data on side effects and complications; vigilance data
- Data affecting the benefit/risk profile
- All PMS and PMCF data require proactive collection and regular processing. Results must be channeled back into the risk management documentation, the clinical evaluation process or even, if necessary, the planning/development phase.
- PMS data:
- Regular planned review and update of documents based on PMS and PMCF activities and ongoing changes in state-of-the-art is legal requirement
- Schedule depends on device risk category and the corresponding medical field
- Regardless of the termination of the device distribution, the manufacturer is obliged to maintain the technical documentation for years (length of time depends on the risk category)
- Terminated distribution aside, responsible manufacturer behavior entails continued monitoring of the devices still in use
Life path of an in vitro diagnostic device (according to the IVDR)
- Exploration of state-of-the-art, critical summary of the literature of the relevant medical field
- Risk classification of the device
- Design and development in the light of requirements of the state-of-the-art & literature knowledge
- Establishment and maintenance of a quality management system from the very beginning of the design & development throughout the entire life cycle
- Simultaneously outlining the structure of the technical documentation
- Creating a general requirement checklist
After the production of the first prototype:
Tests based on harmonized standards, common specifications, or other unspecified tests, such as:
- Sterility tests
- Maintenance tests
- Physical, chemical, analytical, etc. studies that do NOT involve human related tests (therefore not human clinical trials, nor tests with human samples)
In parallel with the preclinical tests, and based on the results of these tests:
- Compilation of the first draft of the Instruction For Use
- Compilation of the first draft of the Risk Management File
- Identification of relevant and specified outcome parameters
- Outline of the different development phases including the sequence and means of determination of the scientific validity, the analytical and clinical performance, including an indication of milestones and a description of potential acceptance criteria:
- Pilot study
- Confirmatory study
- Post-market performance follow-up (PMPF)
Pilot study(-ies):
- Its purpose is to answer questions of which the literature does not provide sufficient information, and to collect preliminary data for confirmatory studies
- For example, a pilot study may collect data to determine the sample number of a confirmatory study
- Based on its results, further planning and development of the device may be required
- It typically has a low patient count
Confirmatory study(-ies):
- It aims to collect justifying evidence from a clinical environment that demonstrates the device's compliance with the relevant general requirements.
- Based on the pilot study results and/or the Performance Evaluation Plan, planning a confirmatory study requires, among others, the following steps to verify the clinical outcome parameters:
- Setting up a hypothesis
- Defining primary and secondary endpoints
- Determining the sample number
- Defining inclusion and exclusion criteria
- Accurate description of trial events
- Compilation of a statistical plan
- The results of confirmatory studies are crucial for the demonstration of clinical conformity, and thus for the compilation of the Performance Evaluation Report.
Tasks related to clinical trials, briefly:
- Compilation of the Performance Study Plan (PSP) based on IVDR and ISO 14155
- Compilation of the Investigator’s Brochure (IB) based on IVDR and ISO 14155
- Compilation of additional essential documentation for the study
- Conduct feasibility study(-ies) in the participating countries
- Official approval (application form)
- Conducting the clinical performance study
- Data collection and evaluation
If all the preclinical and clinical data, Risk Management File, label, Instruction For Use etc., that is, every element of the Technical File is available, then the Performance Evaluation Report [PER] can be compiled to finalize the technical documentation.
- In the case of most Class A devices, manufacturers must register at Competent Authorities and in EUDAMED, issue the Declaration of Conformity and start the marketing
- At higher risk categories, manufacturers must submit the technical documentation to a Notified Body for a conformity assessment procedure
- After a successful conformity assessment & certification, distribution can be launched
- Post-market surveillance both in the market and in the clinic
- Real-life data collection based on PMS and PMPF plans.
- PMS data:
- Sales data
- Complaints (non-clinical)
- Marketing data
- PMPF data:
- Data on the clinical safety and/or performance of the device from the clinic and the literature
- Data on adverse events; vigilance data
- Data affecting the benefit/risk profile
- All PMS and PMPF data require proactive collection and regular processing. Results must be channeled back into the risk management documentation, the clinical evaluation process or even, if necessary, the planning/development phase.
- PMS data:
- Regular planned review and update of documents based on PMS and PMPF activities and ongoing changes in state-of-the-art is legal requirement
- Schedule depends on device risk category and the corresponding medical field
- Regardless of the termination of the device distribution, the manufacturer is obliged to maintain the technical documentation for years (length of time depends on the risk category)
- Terminated distribution aside, responsible manufacturer behavior entails continued monitoring of the devices still in use