A Guide to Medical Devices Regulations: Everything You Need to Know

As an experienced CRO, ECLEVAR understands the importance of medical device regulations to ensure the safety of patients and healthcare providers and guarantee the effectiveness of products. These regulations, which are set forth by the US Food and Drug Administration (FDA) and other regulatory bodies, can be difficult to understand and implement, but cannot be ignored when bringing new medical products to the market. 

This article provides a comprehensive, but simplified, guide to understanding medical device regulations. Explore all sections to learn what are the main requirements, the importance of compliance, and how you can stay informed about the changes in regulations. 

What You Will Learn in This Article 

1. All about medical device regulations in the US 
2. Why it is important to comply with medical device regulations 
3. Global medical device regulations: what to consider  
4. Medical device standards and quality management  
5. The FDA medical device approval process 
6. Labeling requirements for medical devices 
7. How you can stay up to date with regulatory changes  
8. How ECLEVAR can help your company navigate medical device regulations   

What Are Medical Device Regulations in the US 

The Food and Drug Administration (FDA) is the regulatory body responsible for medical devices regulations in the USA. The FDA defines a “medical device” as  “An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals” 

This may look like a complex definition, especially for those who are just entering the medical device industry. However, understanding the FDA set of regulatory requirements is essential to receive clearance to market a new device. This is why ECLEVAR is committed to helping its clients to comply with these requirements and avoid consequences such as fines, recalls, and legal action. 

Classification of Medical Devices 

The medical devices regulations in the US depend on the type, or class, of device. Each class of device has different regulatory requirements, depending on the level of risk to patients that they may offer. There are three classes of medical devices, according to the FDA:

• Class I: Low-risk devices. They are simple in design and usually intended for general use. 
• Class II: Moderate-risk devices. These devices must meet specific performance standards and require special labeling. 
• Class III: High-risk devices. These devices are designed to support or sustain life and may have the potential to cause serious harm to patients. 
• Class I devices are the only ones that usually do not require a premarket notification or clearance from the FDA before entering the market. Class II and III devices, because they are moderate and high-risk devices, need to comply with this premarketing requirement. 

FDA Regulations for Medical Devices 

The medical devices regulations enforced by the FDA cover all parts of the creation and selling of a new medical product, from the design to post-market surveillance. This is to ensure that medical devices are safe and effective for patient use. 
The FDA Quality System Regulation (QSR) outlines specific requirements that manufacturers must comply with when designing, developing, and making medical devices. The QSR stipulates design controls, rules for device identification and traceability, and outlines corrective and preventive actions. 

Medical device manufacturers must also be aware of the FDA’s labeling instructions, which were created to ensure that patients have access to clear guidance on how to use the medical device on the product’s label. Advertising and promotion of medical devices is also regulated by the FDA, in order to ensure that patients are not offered any misleading information. Both sets of regulations are intended to ensure the patients’ safety. 
There are many medical devices regulations that US manufacturers need to comply with and navigating them can be a challenge. However, as this is essential to ensure patient safety and a crucial step of medical device marketing, it is worth learning more about the topic and knowing where to find proper guidance to compliance. 

Why is it Important to Comply with Medical Device Regulations? 

As explained above, the medical devices regulations were created mainly to ensure patient safety and product effectiveness. This is the main reason why manufacturers should care about compliance. Not doing so can also lead to consequences for the manufacturer, as these regulations are enforced by federal law in the US. Product recalls, legal liabilities, and damage to the company’s reputation are some of the consequences that may be faced when medical devices regulations are ignored. 
In addition, adhering to regulatory requirements helps demonstrate the company’s commitment to quality, safety and innovation. It is also essential to stay competitive in the marketplace, since non-compliant products may be excluded from the market and weaken the company’s presence. 

The Role of Regulatory Affairs Professionals in Medical Device Compliance 

Regulatory affairs professionals are the people responsible for studying and interpreting the regulatory requirements. Their role in medical device compliance is vital, since their work is focused on ensuring that product design and the clinical trials are compliant with regulations from start to finish. A regulatory affairs professional is also responsible for obtaining the necessary approvals for a product to be marketed and for coordinating post-market surveillance, monitoring performance and preventing potential safety risks.  

The regulatory affairs department is always up to date with changes in the regulatory requirements to ensure all products under their responsibility remain compliant with FDA regulations. ECLEVAR’s regulatory affairs team works closely with other departments to reduce delays or rejections of products approvals due to difficulties in compliance.  
The regulatory affairs professionals are directly responsible for: 

1. Interpreting regulatory requirements and applying them to product design and approval processes. 
2. Offering consultation on how to prepare and submit regulatory documents such as premarket submissions and post-market reports. 
3. Monitoring regulatory changes and informing the product development team. 
4. Applying quality system regulations such as documentation requirements and product labeling. Learn more about quality standards in another section of this article. 
5. Representing the company during FDA inspections and meetings, as well as other interactions with regulatory agencies. 

It is recommended to have the regulatory affairs team involved in the product development process from the beginning.  This is to ensure that the products will meet regulatory requirements and are more likely to be approved for marketing. Therefore, regulatory affairs professionals are not only essential to ensure compliance but are ultimately responsible for the safety and effectiveness of medical devices. 

Global Medical Device Regulations: what to consider 

This article is focused on the FDA medical devices regulations in the US, which has some of the strictest regulations of the kind in the world. However, since the medical device industry is global and companies from all over the world are competing on the market, it is important to consider other regulations that must be observed when selling medical products in other countries. 
For instance, the European Union’s Medical Device Regulation (MDR) has recently updated its text to include different requirements for clinical evaluations and post-market surveillance. Another example can be found in China, where medical device regulations were overhauled in 2020, establishing new requirements for clinical trials and product registration. 

The best way to be compliant with global medical device regulations is to work with a regulatory expert’s team that is aware of the different requirements in each country. ECLEVAR is present in various countries and its international team of knowledgeable experts is ready to assist your company to be compliant with national and international medical devices regulations.  

Medical Device Standards and Quality Management 

National medical devices regulations of regulatory bodies are one of the key concerns of manufacturers that want to ensure their medical products are effective and safe for use. However, they are not the only requirements to consider. Companies must also comply with medical device standards and quality management systems in all stages of a product making process.  

The ISO 13485 standard, for instance, is often mentioned in regulatory approval processes in many countries. This international standard is “designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services”, being ideal to manage quality through the complete life cycle of a medical device. 

Other important standards are the ISO 14971 standard, which deals with risk management, and the IEC 62304 standard, which “defines the life cycle requirements for medical device software for software development”.  
Regular audits, testing, and documentation are part of the routine of medical device companies that maintain compliance with these standards. Make sure your company is assisted by a team of experts like ECLEVAR’s to integrate quality control into every aspect of your product development and manufacturing process, ensuring patient safety and product effectiveness, reducing the risk of defects and keeping product quality consistent. Of course, this is not just necessary to safeguard patient safety, but also helps your company to build a trustful relationship with healthcare professionals and improve the company’s reputation in the market. 

The FDA Medical Device Approval Process: What You Should Know 

Now that you already know the importance of FDA medical devices regulations in all stages of a product’s life cycle, you are ready to dive deeper into the rigorous approval process that a medical product must go through before it is ready to be available to patients in the US. This is a complex list of steps, and the process can take months or years to complete. After the product was designed, developed and tested, it still needs to go through this approval process to ensure its safety and effectiveness. Keep reading to learn more about each step. 

Premarket Notification (510(k)) 

Premarket notification, or 510(k) process, is the requirement to allow most medical devices to be marketed. It requires submission of a premarket notification to the FDA that demonstrates that the device is substantially equivalent to another one that is already legally marketed in the US. 

Premarket Approval (PMA) 

This step is more rigorous than the 510(k) process and is required for high-risk medical devices. Extensive data and documentation should be provided during a PMA application, demonstrating the safety and effectiveness of the device. 

Device Classification 

This process must be done before premarket notifications or PMA applications. The FDA classifies devices according to their intended use and level of risk, as seen in the beginning of this article. 

Quality System Regulation 

The FDA’s Quality System Regulation (QSR) determines how medical devices should be designed, developed and manufactured, and how post-market surveillance must be conducted. 

Labeling and Advertising 

There are also regulations about labeling and advertising that manufacturers need to comply with. Labels and advertising should accurately represent the product’s intended use. Read more about medical device labels in the next section of this article. 

What are the Labeling Requirements for Medical Devices? 

Labels are not just a detail of a medical device manufacturing and approval process. They are a key element of patient safety and also regulated by the FDA, which has strict labelling requirements that must be met before a medical product is ready to be made available on the market. 

The following table shows all elements that a medical device label must include and what information they must provide to patients: 

• Labeling Element 
• Information 
• Device Name 
• The name chosen for marketing as it appears on the device itself or its packaging 
• Intended Use 
• What the product is for and how it should be used 
• Warnings and Precautions 
• What are the potential risks or hazards associated with the use and how to avoid them 
• Directions for Use 
• Clear instructions on how to use the device:  preparation, handling, and disposal instructions 
• Contraindications 
• List of conditions or situations which impede the use of the device 
• Storage and Handling Information 
• How to adequately storage and handle the device to maintain its effectiveness and safety 
• Expiration Date 
• The date until which the device is apt for using 

Compliance with labeling requirements is part of a medical device approval process. The FDA also requires that any changes in labeling are submitted for approval before being implemented. As demonstrated above, adequate labeling is necessary to ensure proper use of medical devices and avoid potential risks for patients. 

How You Can Stay Up to Date with Regulatory Changes 

The medical device industry is very dynamic and so are the medical devices regulations. New requirements and guidelines are always being introduced by the FDA and other regulatory bodies. To ensure solid compliance with the current regulations, it is necessary to stay informed about these changes. These are some simple actions you and your company can take: 
Work closely with well-informed regulatory affairs professionals that share information and insights about changes in regulations. 
Subscribe to email newsletters and publications that publish the latest industry developments. 
Stay informed about conferences and events where you can hear from experts in the field. These events are great opportunities to learn about the latest developments, and also to build relationships with other professionals with the same interests and concerns. 

Regularly check the FDA’s website, where any changes in medical devices regulations will be announced. 

How ECLEVAR Can Help Your Company Navigate Medical Device Regulations  

Understanding medical devices regulations can be challenging. As this article has shown, the set of rules and guidelines set forth by the FDA and other regulatory bodies are complex and are meant to control all stages of a medical product’s life cycle.  
Compliance with these regulations is, however, essential for ensuring patient safety, contributing to public health. Medical device manufacturers should adhere to regulatory requirements and keep high-quality standards to market products that are safe and effective. Companies should also meet international standards and know quality management systems that govern the design, development, manufacturing, labeling and advertising of medical devices. 

Therefore, compliance with medical devices regulations requires significant expertise and a deep understanding of the regulatory landscape. The best way to ensure that your company is up to date with regulatory changes and your products are compliant with all relevant regulations is to work with experienced regulatory affairs professionals. 

Contact ECLEVAR’s team of experts for comprehensive guidance on how to navigate the compliance and approval process of your medical devices. 

What You Have Learnt in This Article: Some Takeaway Points 

• Medical device regulations are essential to ensure the safety, effectiveness, and quality of medical devices, protecting the patients. They guide the design, development, manufacturing, and marketing of medical devices.  
• The FDA (Food and Drug Administration) is the US regulatory body which oversees medical device regulations. It reviews and approves medical devices before they can be marketed, sets regulations and standards for their safety and effectiveness, and conducts inspections and audits to ensure compliance with these regulations. 
• Compliance with medical device regulations is essential to ensure patient safety and product effectiveness and avoid harm to patients, legal penalties and damage to the reputation of medical device companies. 
• Regulations can vary from country to country. It is important to work with experts in clinical research and medical product development that are aware of the many different regulations. 
• There are quality management systems to ensure that quality standards such as the ISO 13485 are met. 
• Regulatory affairs professionals are the people directly responsible for preparing and submitting regulatory submissions. They also provide guidance and support to other teams to ensure complete medical devices regulation compliance. 
• There are several steps in the FDA medical device approval process. Premarket notification (510(k)), premarket approval (PMA), and device classification are some of the steps to consider before a medical device can be marketed in the US. 
• Medical device labels should include information that ensures proper use and patient safety. The FDA has a set of guidelines on how to design medical device labels. 
• Medical devices regulations are subject to regular changes, and it is essential to stay up to date by regularly checking the FDA’s website for updates, subscribing to industry newsletters and engaging with regulatory experts.