CLINICAL INVESTIGATIONS FOR MEDICAL DEVICES (MDR)

Designing and conducting clinical studies to demonstrate safety, performance, and clinical benefit

Certification of a medical device, according to Regulation (EU) 2017/745, is supported by appropriate clinical data that can confirm or demonstrate its safety, performance or efficacy. Each device has its own pathway: there is no "one-size-fits-all prescription." By designing a pre-market clinical investigation or by designing a proactive post-market surveillance plan, you can collect clinical data, actual use data, feedback, reports, and manage complaints/noncompliance in a structured way.

The study design must be methodologically sound, statistically justified, and consistent with:

Annex XV MDR
ISO 14155
Clinical Evaluation Plan (CEP)
Risk Management
Claim and intended use of the device

FTR Advisor supports in defining clinical strategy, methodological design, conducting and reporting of pre-market and PMCF prospective clinical trials.

When is a clinical study required?

A clinical investigation may be required in the following cases:

Class III and implantable devices
Inability to demonstrate clinical equivalence
Innovative devices or devices with new technologies
New indications for use
Need to collect new or more data
Confirm benefit/risk profile
Verify real-world performance
Collect data on specific subpopulations

Our methodological approach

1. Defining the clinical strategy

Analysis of clinical rationale, intended use, and claims
Check for consistency with defined endpoints with clinical benefits
Rational justification of sample size

2. Documentary design

Drafting and structuring of:

Clinical Investigation Design Gantt.
Synopsis
Clinical Investigation Plan (CIP)
Investigator's Brochure
e-Case Report Form (e-CRF)
Monitoring Plan
Documentation for Ethics Committee
Documentation for Competent Authority

Each document is developed consistent with CEP, GSPR and Risk Management.

3. Study initiation and conduct.

Coordination with clinical centers
Monitoring and supervision
Management of deviations and adverse events
Quality control of collected data

The goal is to ensure data integrity and regulatory compliance.

4. Statistical analysis and reporting

Statistical analysis according to predefined plan
Clinical Investigation Report (CIR)
Integration of results into the ERC