Clinical Evaluation and Clinical Investigations (Ch. 12) Flashcards
What is a clinical evaluation?
Clinical Evaluation:
A methodologically sound ongoing procedure to collect, appraise, and analyze clinical data pertaining to a medical device, and to analyze whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s IFU
Per both MDD and MDR, what classes of devices is a clinical evaluation required for?
All Classes!
What is the definition of clinical data?
Clinical Data (per MDR):
Information concerning safety or performance that is generated from the use of a device and is sourced from:
- a clinical investigation of the device concerned
- a clinical investigation reported in scientific literature for an equivalent device
- reports in scientific literature on clinical experience
- clinically relevant information from post-market surveillance (PMCF)
What is the definition of clinical evidence?
Clinical evidence:
- The clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefits
What is the definition of clinical performance?
Clinical performance:
- The ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients (when used as intended by the manufacturer)
What is the definition of clinical benefit?
Clinical benefit:
- The positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome, including outcomes related to diagnosis, or a positive impact on patient management or public health
How do clinical evidence, clinical evaluation, and clinical data relate?
Clinical evidence: Composed of evaluation + data for devices, information supports safety/performance of device
Clinical evaluation: Systematic process to collect and analyze clinical data, determines clinical benefits, benefit-risk ration
Clinical data: clinical investigations, clinical literature, comparison to equivalent devices, review of PMS
What is MEDDEV 2.7/1 rev 4?
MEDDEV 2.7/1 rev 4:
Guidelines on Medical Devices: Clinical Evaluations
- the de facto standards for clinical evaluations and supporting processes
What is the structure of MDR Annex XIV?
MDR Annex XIV: Clinical Evaluation and PMCF
Part A: Clinical Evaluation
Part B: Post-Market Clinical Follow-Up (PMCF)
What are the main factors to be considered when planning a clinical evaluation?
The clinical evaluation should be proportionate to the nature, classification, intended purpose, risks of the device, and the manufacturer’s claims
What is a device equivalence?
Using an equivalent device’s clinical data - technical, biological, and clinical characteristics can be used to demonstrate equivalence
MDR: The two manufacturers must have a contract in place that allows full access to the marketed device’s technical documentation on a continual basis
What do clinical investigations establish/verify?
- Suitable for purpose / intended use
- Clinical benefits claimed
- Clinical safety / identify side-effects
- Benefits-risks
Generally, clinical investigations are performed for what types of devices?
Class III and Class II implantables
exceptions: device is modified from previous, equivalent to another marketed device
What types of adverse events occurring during a clinical investigation must be reported?
- Any serious adverse event that has a casual relationship with the investigational device
- Any device deficiency that might have led to a serious adverse event (near-miss)
How often is a clinical evaluation updated?
Occurs throughout the lifecycle of a medical device as an ongoing process - defined by manufacturer
What is Post-Market Clinical Follow-Up (PMCF)?
PMCF: a continuous process that updates a manufacturer’s clinical evaluation
What is the purpose of PMCF?
To confirm the safety and performance of a device throughout its expected lifetime
To ensure continued acceptability of identified risks and detect emerging risks
What is included in the PMCF plan?
Documented, proactive, organized methods and procedures to collect clinical data based on the use of a CE-marked device corresponding to a particular design supporting safety and performance
What is the purpose of a PMCF study?
To answer specific questions relating to clinical safety and performance of a device (when used accordance with its approved labeling)
What data sources can be used for the PMCF?
Patient registries, Vigilance reporting, Patient monitoring, Usability, Customer surveys, Feedback, Complaints
What is a summary of the process for performing a clinical evaluation?
- Clinical evaluation plan
- Identify data that can be used (develop a search protocol)
- Evaluate clinical data
- Analyze clinical data
- Clinical evaluation report
What are the qualifications needed for the clinical evaluation reviewer?
Must have 10+ years of experience, a declaration of interest and CV needs to be provided
What needs to be considered when setting up a clinical strategy?
- Standards / clinical requirements / regulations
- Select clinical data sources
- Determine quality of current data
- Determine how to set up clinical investigation, PMCF study, or registry
- NB input
What is ISO 14155?
ISO 14155:2020 - Clinical Investigation of Medical Devices for Human Subjects - Good Clinical Practices (GCP)
What part of the MDR addresses clinical investigations?
MDR Annex XV
What is a CRO?
CRO: Clinical Research Organization
What does EC stand for?
EC: Ethics Committee
What are the basics for a clinical investigation?
- Clinical Investigation Protocol (CIP)
- Site agreements
- CRO and vendor agreements
- Investigator’s brochure (IB)
- Ethics Committee (EC) approval
- CA Application
- Informed Consent Form
- Case Report Form (CRFs)
- Electronic Data Capture System (EDC)
- Clinical Investigation Report (CIR)
