Medical Device Clinical Trials and Regulation
Clinical trials for medical devices differ substantially from pharmaceutical drug trials in both methodology and legal regulation. This category encompasses everything from simple bandages to complex implants and diagnostic equipment. In Georgia, the medical device market is developing actively, though legislation is still in the process of harmonization with EU regulations (MDR). This creates certain legal vacuums and uncertainties for manufacturers. Clinical evaluation is essential to confirm a device's safety and performance, which subsequently becomes the basis for its registration.
Legal.ge offers specialized legal services for medical device manufacturers and researchers. Our lawyers will assist you in correct device classification, obtaining trial permits, and interacting with the regulator to ensure the lawful and safe testing of your innovation.
What Does Medical Device Trials Service Cover?
Our service is tailored to the specifics of medical technologies and includes:
- Device Classification: Legal assistance in determining the device's risk class (I, IIa, IIb, III), which dictates the strictness of regulation.
- Permit Documentation: Preparing the clinical trial application, legal review of the Technical File and risk analysis document.
- ISO 14155 Standard: Consultation on compliance with the Good Clinical Practice (GCP for devices) standard for medical devices.
- Ethical Approval: Resolving specific ethical issues, especially for implantable devices (e.g., what happens after the trial ends).
- Software as a Medical Device (SaMD): Regulating trials for digital health apps and AI-based diagnostic systems.
- Post-Market Clinical Follow-up (PMCF): Legal assurance of plans for clinical surveillance after market access.
Common Situations and Scenarios
One scenario involves testing a new surgical implant. The manufacturer wants to confirm its durability. Unlike drugs, placebo controls are often impossible here. A lawyer helps the company prepare an ethical justification for the study design for the Ethics Committee to prove that risks are manageable.
Another current topic is medical apps. Many developers do not realize their diagnostic app is a medical device requiring clinical validation. A lawyer assesses the app's functionality and determines if it is subject to regulation, protecting the company from illegal activity.
Georgian Legislation and Legal Framework
The field is regulated by the Law on Health Care and the Law on Patient Rights. Specific technical regulations are gradually approaching EU MDR (Medical Device Regulation) standards. Georgia has government decrees defining market access conditions for devices, but for clinical trials, general principles are used, requiring qualified legal interpretation.
Process of Receiving Services
The client approaches Legal.ge with a product description. The lawyer classifies the device and determines the regulatory route. Documentation is then prepared for the Ethics Committee and the Ministry (if required). During the trial, the lawyer provides legal support for incident reporting (device malfunction). The final goal is to obtain a package of clinical data suitable for registration.
The medical technology field evolves rapidly. Legal.ge helps you keep pace with innovations while staying within legal frameworks.
Why Choose a Specialist on Legal.ge?
Medical device law differs from pharmaceutical law. It requires knowledge of technical standards (ISO) and risk management. On Legal.ge, you will find lawyers who understand the difference between a drug and a device and will help you comply with specific regulations.
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