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REGULATION AND REGISTRATION
OF MEDICAL DEVICES
If you need to bring your products to market in compliance with the most demanding regulations, we're here to help. With our experience with regulations in the United States, Europe, the United Kingdom, Canada, Dubai, and more, we offer the support you need to ensure your devices meet the highest standards of safety and effectiveness.
Simplify the approval process and ensure the success of your medical devices.
Let us guide you through the complex world of healthcare regulation!
WHAT ARE MEDICAL DEVICES?
Medical devices are products used in the diagnosis, prevention, monitoring, and treatment of diseases or medical conditions. Unlike medications, these devices do not achieve their purpose through pharmacological, immunological, or metabolic means, but rather through physical, mechanical, or technological mechanisms.
Medical devices range from simple products, such as bandages and thermometers, to advanced equipment such as pacemakers, prosthetics, and robotic surgical instruments.
CLASSIFICATION OF MEDICAL DEVICES
Medical devices are classified according to their level of risk to the patient and user. Globally, many regulations follow the classification established by agencies such as the FDA (United States) and the EU's MDR (Mechanical Regulations).
CLASS I - LOW RISK
Includes general-use products such as bandages, medical gloves, and stethoscopes. They do not require strict certification.
CLASS IIa - MODERATE RISK
Devices such as hearing aids, contact lenses, or ultrasound equipment require safety testing.
CLASS IIb- HIGH RISK
This includes infusion pumps, neonatal incubators, and ventilators. Their approval requires stricter certifications.
CLASS III - CRITICAL RISK
Implantable devices such as pacemakers, heart valves, and hip replacements are subject to rigorous regulations and clinical trials.
GENERAL PRINCIPLES IN THE REGULATIONS OF MEDICAL DEVICES
01
Risk Assessment and Classification
All regulatory systems classify medical devices according to the potential risk they may pose to the user.
02
Studies
Clinicians
For more complex or high-risk devices, safety and efficacy must be demonstrated through clinical studies.
03
Surveillance Systems
Post-Marketing
Once on the market, devices must be monitored to detect and resolve any safety issues.
04
Evaluation of
Accordance
Manufacturers must demonstrate compliance with applicable regulatory standards through technical documentation.
MEDICAL DEVICES REGULATIONS
Belab Services offers a comprehensive service for reviewing, correcting, and generating all the necessary documentation for obtaining registration in different areas of the world, acting as the legal representative and guarantor of regulatory compliance with the requirements and requisites of the authorities.
UNITED KINGDOM
MHRA (Medicines and Healthcare products Regulatory Agency)
Following Brexit, the United Kingdom continues to regulate medical devices through the MHRA, although it has decoupled itself from the European Union's MDR regulation.
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Classification: The devices are classified similarly to the European Union (Class I, IIa, IIb and III).
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UKCA Mark: Since January 2021, devices in the UK must bear the UKCA Mark (instead of the CE marking) to demonstrate compliance with British regulations. However, the CE marking remains temporarily valid until the end of 2024.
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Notified Bodies: In the UK, conformity assessment bodies must be registered with the MHRA and are responsible for assessing higher-risk devices.
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Clinical research: High-risk devices require clinical trials before being marketed.
With over 10 years of experience in safety assessments for cosmetics, food supplements, homecare products, and medical devices, BELAB SERVCES offers a comprehensive and reliable solution for effectively verifying and registering your products. Our solution, based on a deep understanding of the legislation, relies on a team of scientific consultants and advanced IT tools, makes it the fastest and most reliable route to entering the European market.
