When conducted under the MDR, they must also comply with any applicable common specification, defined in Article 2(71) of the MDR as a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
Pre-market clinical investigations are usually conducted to produce clinical data to support clinical performance and/or safety in the context of CE marking.
Our seasoned physicians and clinical research professionals assist you in the planning, management and evaluation of clinical trials. They can help you design robust protocols by advising on study goals, eligibility criteria, study evaluation and design options, and writing MDR-compliant protocol synopses.
Protocols are designed to enable timely patient recruitment and provide robust answers to scientific questions. You will benefit from strong clinical study oversight, which is key to a successful, timely and cost-effective medical device development process.
Experienced physicians and clinical researchers guide your trial from protocol design to final report.
All protocols and documentation are designed to meet MDR requirements from the outset.
Efficient trial management and timely patient recruitment reduce overall development costs.
Our team works closely with you to develop a trial design that answers your scientific questions while meeting all regulatory requirements. We consider:
Comprehensive protocol design aligned with MDR requirements
Identification and engagement of qualified clinical sites
Ongoing monitoring and quality assurance throughout the trial
Comprehensive clinical trial report ready for regulatory submission
Our team has extensive experience with the EU Medical Device Regulation (MDR) and ensures that all aspects of your pre-market clinical investigation comply with current requirements.
We stay updated on regulatory changes and guidance to ensure your trial remains compliant throughout its duration.
Years of experience managing successful pre-market clinical trials
Physicians, clinical researchers, and regulatory specialists
Advanced EDC platform for efficient data management
Strong partnerships with clinical sites across Europe
Our proprietary EDC platform streamlines data collection and management throughout your clinical trial.
Monitor trial progress with live data visualization and reporting
21 CFR Part 11, GDPR, and MDR compliant data management
Seamless workflow integration with existing clinical systems
A pre-market clinical investigation is a study conducted on a medical device that is not yet CE marked. It is designed to generate clinical data to support the safety and performance claims required for regulatory approval under the MDR.
The duration varies depending on the device, study design, and patient recruitment. On average, pre-market clinical trials take 12-18 months from protocol approval to final report submission.
Pre-market trials must comply with MDR requirements including proper protocol design, ethics committee approval, informed consent procedures, adverse event reporting, and comprehensive documentation of all trial activities.
We leverage our extensive network of clinical sites and use AI-powered tools within the Milo Healthcare platform to identify and recruit eligible patients efficiently, reducing recruitment timelines and costs.
You will receive a comprehensive Clinical Investigation Report (CIR) that includes all study data, statistical analysis, safety assessments, and conclusions. This report is designed to support your regulatory submission for CE marking.
