Medical Device Regulation

Introduction

For medical device newbies, regulation and quality can seem like daunting topics. Most people know that medical devices are regulated, but many misconceptions exist about how these regulations are developed and applied. The most common misconception is that regulation and regulatory affairs involve large amounts of time-consuming, mindless paperwork. A second common misconception is that regulatory activities are performed at the end of the development process. Neither is true (at least, not entirely accurate), and these misconceptions are often the root cause of many medical device company failures.

MedDev Central is passionate about helping medical device manufacturers use regulation and quality requirements to build better products. To achieve this, it is necessary to understand the regulatory landscape. This MedDev Central Knowledge Hub chapter is devoted to providing basic information on medical device regulation worldwide.

As with many aspects of medical device development, understanding begins with definitions. What is regulation? Why do we need it? Who is responsible for it? Are regulation and quality the same thing? Keep reading to find out.

What is medical device regulation?

Regulation is the set of laws, guidelines, standards, and oversight processes established by governmental and other authorities to ensure medical devices are safe, effective, and of high quality.

These regulations encompass the entire lifecycle of medical devices, starting from design and development through manufacturing, distribution, and after-market operations, including ongoing management of the devices.

Many first-time innovators treat medical device regulation as a series of “tick-box” activities. Like filling out a visa application or some other pointless government form. On the contrary, medical device regulations are a collection of legislation, standards and guidelines that collectively describe:

• What a manufacturer must demonstrate in terms of benefits and risks of medical device and
• How the manufacturer should perform the work.

As there are more than 10,000 different types of medical devices on the market, the regulations must be very broad to accommodate them all. This means that the regulations are not prescriptive. They do not provide step-by-step instructions that must be followed sequentially. It is the manufacturer’s job to interpret the regulations and decide how to apply them to their product and company. Far from mindless box-ticking, this intellectual exercise requires knowledge and experience.

Why is regulation necessary?

Regulation plays a vital role in protecting public health. Medical device innovators often complain that regulations are a cage, hindering innovation and delaying product development. By contrast, regulations can promote innovation and foster trust among patients and providers. Regulations are designed to ensure safety and effectiveness while offering a framework that nurtures innovation. By establishing clear requirements, regulations can steer technological advancements in a manner that prioritises user safety. The extent to which regulation is balanced with risk differs worldwide, depending on the remit of different regulatory authorities.

The primary goal of regulation is to guarantee that medical devices fulfil their intended purpose safely. Medical device regulations require manufacturers to demonstrate that the benefits of using a medical device outweigh the potential risks. Manufacturers are tasked with assessing and mitigating risks associated with their devices. They must also provide robust evidence to support all performance claims.

Regulations dictate the standards for medical device design, manufacturing, and quality control. Quality standards ensure that manufacturers produce devices consistently to meet user needs. Establishing a quality-centric organisational culture also helps manufacturers reduce costs from product defects and minimise reputational damage. High-quality products equal satisfied customers, fostering trust.

While medical device regulations differ across the world, they share a range of common purposes. Efforts towards international regulatory harmonisation help streamline trade by fostering global consistency, simplifying compliance for manufacturers looking to access international markets.

What is the difference between regulation and regulatory affairs (RA)?

Medical device regulation provides rules and standards, while regulatory affairs (RA) involves planning and performing organisational activities to comply with those rules and standards.

Regulation is an external framework imposed by authorities. By contrast, RA is an internal function that exists within all medical device manufacturers. While regulation defines what needs to be done to ensure devices are effective and safe, regulatory affairs focus on achieving and maintaining compliance with these regulations. The role of an RA professional includes:

• Developing and implementing regulatory strategies. A regulatory strategy involves researching and planning for the regulatory requirements in different markets.
• Preparing and submitting documentation to regulatory authorities for conformity assessments.
• Communicating with regulatory bodies to facilitate approval processes, clarify requirements, and resolve any issues that arise during a product review or audit.
• Ensuring ongoing compliance with regulatory requirements throughout the product lifecycle. This involves staying updated on regulation changes, conducting internal audits, and ensuring post-market surveillance activities are performed.
• Educating other employees about regulatory requirements and best practices.

What is quality in medical devices?

Quality in medical devices refers to the attributes and characteristics of the devices that meet specified requirements and satisfy user needs. While regulation sets the minimum safety and compliance requirements that must be legally met, quality focuses on achieving and maintaining those requirements.

External governmental and international authorities impose regulations. In contrast, quality is managed internally by the organisation through quality management. Quality management is about ensuring medical devices consistently meet regulatory and user requirements. Quality Management Systems (QMS) are formalised systems that document processes and responsibilities for achieving quality objectives. Quality Assurance (QA) are professionals who ensure organisations establish and maintain effective quality policies and activities.

Conclusion

In combination, regulation and quality are distinct but related concepts that help manufacturers develop, manufacture and market medical devices worldwide.

No medical device or healthcare intervention is without risk. Regulations exist to balance those risks with anticipated clinical benefits. Manufacturers are expected to demonstrate that risk/benefit balance by complying with the regulations. Regulatory Affairs and Quality Assurance (RAQA) are internal functions that help organisations fulfil their regulatory obligations and consistently produce high-quality devices.

This MedDev Central Knowledge Hub section explores the leading regulatory authorities and regulations governing medical devices across the world.

Resources