Regulatory Landscape - Overview

Medical robot Regulatory Landscape: Product Overview

Medical robotics refers to the field that involves the design, development, and use of robotic systems to assist in medical procedures, healthcare delivery, and patient care. This system is used for surgical assistance, rehabilitation, diagnostics, telemedicine, hospital automation and many more.

Medical robot types

The medical robotic segmentation, based on product, includes surgical robots, rehabilitation robots, noninvasive radio surgery robots, hospital & pharmacy robots, emergency response robotic systems, logistics/handling robotic systems, imaging robotic systems.

Furthermore, the rehabilitation robots’ segment is further divided into assistive robots, prosthetics, orthotics, therapeutic robots, and exoskeleton robotic systems. Moreover, the hospital and pharmacy robots are further divided into telemedicine robots, I.V. robots, pharmacy robots, and cart transportation robots.   

Medical Robotics Applications

Rehabilitation robots augment patient rehabilitation through the application of robotic devices. These robots allow patients to practice movements aided by the robot. In recent years, there has been a rapid and vast development of robots for the rehabilitation of sensorimotor deficits after damage to the central nervous system (CNS).

For instance, in December 2021, in robotics Social Robotics launched an AI-based robotic device to improve health rehabilitation. Simiarly, in November 2019, Toyota Motor Corporation (Toyota) launched the new Welwalk WW-2000, a robot designed to provide rehabilitation support to individuals with lower limb paralysis as a result of stroke and other causes. In addition, current advancements in rehabilitation processes, methodologies, tools, and the rapid incorporation of AI are expected to increase the use of rehabilitation robots.

Robots like da vinci surgical system provide high precision, flexibility and control during minimally invasive surgeries. Surgeons operate via a console, reducing human error and enabling complex procedures with smaller incisions and faster recovery. Surgical robotics has emerged as a new growth point and technological incubator in modern surgery. Robot-assisted surgeries were developed to augment the capabilities of surgeons while performing open surgeries on a patient or to address the limits of existing minimally invasive surgery technologies. Minimally invasive surgery with surgical robotics aids in reducing recovery time, accelerating healing, and in avoiding scarring. The increased need for minimally invasive surgical treatments, as well as the use of medical robotics in helping with surgical procedures, have significantly improved the efficacy of surgical operations. 

Robots enable remote consultations and examinations. Telepresence robots allow doctors to interact with patients from a far, especially useful in rural or quarantined areas.

Medical Robotics Development steps.

Medical robotics is the evolving field in healthcare, robotic system developed with different levels of autonomy, shaping both design and functionality. In guiding safe and effective innovation, the integration of autonomy levels from fully manual to fully autonomous systems in the product development process is essential. There are 6 widely recognized levels of autonomy, ranging from Level 0 (no autonomy) to Level 5 (full autonomy with no human involvement). Incorporating this framework in early and throughout the development lifecycle ensures that technical design, regulatory strategy, and user requirements align with the intended clinical application and degree of human oversight. The following outlines how these autonomy levels can be systematically embedded into each stage of medical robotic product development.

Level 0-No autonomy: This includes devices which respond and follow users’ commands like tele-operated robots or prosthetic devices, surgical robot with motion scaling also fits this category as its output represents the surgeon’s desired motion.

Level 1-Robot assistance: Robots require mechanical assistance during a task, with continuous human control of the system, for instance, surgical robots with virtual fixtures (or active constraints) (and lower-limb devices with balance control.

Level 2-Task autonomy: The robot with autonomous system for specific tasks, which are initiated by a human. The difference includes operator having only discrete control than continuous control of the system. For instance, surgical suturing-surgeon indicates where a running suture should be placed, and the robot follows the command and performs the task autonomously and surgeon monitors and intervenes if needed.

Level 3- Conditional autonomy: A system generates task strategies but relies on a human to choose from different strategies or to approve an autonomously selected one. This type of surgical robot can perform tasks without close supervision. Similarly, an active lower-limb prosthetic device can detect the wearer's intention to move and adjust automatically without requiring direct attention from the wearer.

Level 4-High autonomy: Under the supervision of a qualified doctor, robots can make medical decisions. A robotic assistant that carries out surgery while being overseen by a attending surgeon.

Level 5-Full autonomy (no human needed): A "robotic surgeon" that can perform an entire surgery independently is currently a concept found in science fiction. This term broadly refers to a system capable of performing all procedures that a general surgeon might do. However, such a robotic surgeon does not exist in reality yet.

Medical Robotics Market Size Overview

As per MRFR analysis, the Medical Robotics Market Size was estimated at 18.07 (USD Billion) in 2024. The Medical Robotics Market Industry is expected to grow from 20.91 (USD Billion) in 2025 to 77.63 (USD Billion) till 2034, at a CAGR (growth rate) is expected to be around 15.69% during the forecast period (2025 - 2034).

Medical Robotics Regulatory Landscape:

There are several key regulatory agencies who oversee the approval and monitoring of Medical Robotics to ensure their safety, efficacy, and quality.

Medical Robotics Guidelines:

Robotically assisted surgery is a valuable treatment option but may not be suitable for every situation. Discussing with physician about the risks and benefits of robotically assisted surgeries, as well as other treatment options is very important before starting with treatment. The advantages of a RAS device include enabling minimally invasive surgery and assisting with complex tasks in confined body areas. However, the device is not an actual robot, as it cannot perform surgery without direct human control.

Medical Robotics Classification of the Product:

Medical Robotics Regulatory Process Overview, By Country:

Regulation of medical robots fall under the category of medical devices regulation, it makes sure that robotic systems used in healthcare are safe, effective and reliable.

Food and drug administration (FDA) regulates medical robots as medical devices, most of the medical robots fall under class II and class III medical devices, depending on the associated risk and the use of the device. Class II devices are of moderate risk to patients and class III devices are said to be life sustaining devices and considered to be high risk devices.

In the US, the FDA regulates medical devices, including robotics, through its Center for Devices and Radiological Health (CDRH). The FDA’s guidelines focus on premarket approval, post-market surveillance, and compliance with the Medical Device Reporting (MDR) regulations.

Regulatory submissions required for medical Robotics

• 510(k) clearance: For devices which are classified as class II, require this premarket notification 510(k) clearance, which involves submission of substantially equivalent device which is legally marketed as a evidence in approval of new medical device.
• Premarket Approval (PMA): For high-risk Class III medical devices submission of approval is a must, which requires submission of extensive clinical data and involves strict regulatory review, inspecting the safety, efficacy, and quality of the medical devices as they are life-threatening devices.
• De Novo pathway: The De Novo classification process by the FDA is a regulatory pathway for medical devices that do not have a legally marketed predicate device. It allows for the classification of devices into Class I or Class II based on their risk level.
• HIPAA Compliance: It is a Law regarding data privacy and security, regulating how patient information is managed during robotic procedures. Adherence and compliance with these regulations are important for maintaining patient trust and ensuring confidentiality.
• Breakthrogh Grant: it is FDA’s Breakthrough Devices Program, accelerating approval for innovative technologies, including medical robots, which improve patient access to advanced treatments.

The FDA has approved Robotically Assisted Surgical (RAS) devices for use by trained physicians in operating rooms for various laparoscopic surgeries, including general, cardiac, colorectal, gynecologic, head and neck, thoracic, and urologic procedures. Common surgeries using RAS devices include gallbladder removal, hysterectomy, and prostatectomy. While robotically assisted surgery is considered safe and effective for certain procedures when used correctly and with proper training, the FDA has not authorized any RAS device system for the prevention or treatment of cancer in the United States.

Other Regulatory Bodies involved in the regulation of medical robotics are as follows:

Globally, organizations like the EMA and WHO establish international standards for healthcare robotics. The EMA's framework focuses on CE marking to ensure compliance with safety and health requirements. Meanwhile, WHO guidelines emphasize equitable access and ethical considerations in the adoption of robotic technologies. Countries within the EU adhere to the Medical Device Regulation (MDR) to maintain consistent safety and performance standards. These international standards promote collaboration and interoperability among different healthcare systems, ensuring that robotic innovations benefit patients worldwide.

Medical Robotics updates

March 2025, Cedars-Sinai Medical Center in Los Angeles recently performed the first robot-assisted microsurgery for head and neck cancer in the U.S. using the Symani Surgical System. This system, developed by Medical Microinstruments Inc., allows for precise, minimally invasive surgery, reducing recovery times for patients. The Symani Surgical System features advanced technologies like motion scaling and tremor filtering, enabling surgeons to operate on very small structures with high precision. This breakthrough surgery marks a significant advancement in the field of robotic-assisted microsurgery.

April 2025, Medtronic submitted its Hugo robotic-assisted surgery system to the FDA for approval. This submission follows the successful completion of a study that demonstrated the system's safety and effectiveness. The study, which included 137 patients undergoing urologic procedures, showed a 98.5% surgical success rate, surpassing the 85% benchmark. The Hugo system is designed for a wide range of soft-tissue procedures and features advanced technologies like wristed instruments, 3D visualization, and a cloud-based surgical video management solution. Additionally, the Hugo system has received CE mark clearance in Europe.

Medical Robotics Regulatory Challenges and possible risk in development:

Regulatory challenges for the medical robotic devices increase as the level of anatomy of the device increases. FDA undertakes strict review and provide clearence via 510 (k) premarket notification and premarket approval (PMA) pathway of regulation. There is a significant regulatory issue regarding this submission, for instance, cost to bring medical device to the market under 510 (k) program is $31 million roughly, and under PMA pathway it cost around $94 million. Furthermore, it takes almost 10 months for 510 (k) device clearance and around 54 months for device with PMA submissions. These regulatory issues may pose barriers to innovation, competition, and development, especially for technology start-ups.

Healthcare robotics face several ethical challenges. One major concern is that patient autonomy might be compromised due to reliance on robotic systems for surgeries. Regulatory bodies stress the need for transparency and ethical practices to maintain patient trust. Additionally, protecting patient data privacy is crucial, especially when robotic systems handle sensitive information.

Technical limitations are a barrier to the wide use of healthcare robotics. These systems need to be highly reliable and precise but achieving this is often complex and expensive. Financial challenges include the large initial investment needed in the development of robotic systems. Additionally, the costs for ongoing maintenance and training add to the financial strain. Smaller healthcare facilities, in particular, struggle to allocate the necessary resources for these technological advancements.

Medical Robotics Competitive Landscape Dashboard:

Companies With Marketed Medical Robotics:

• Auris Health Inc. (US)
• Medtronic (Ireland)
• Zimmer Biomet (US)
• Renishaw Plc. (UK)
• Health Robotics S.R.L (Europe)
• Stryker (US)
• Intuitive Surgical (US)
• KUKA AG (Germany)
• CMR Surgical (UK)