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Medical Device Regulations

Medical Device Compliance: All You Need to Know

All medical device manufacturers must establish quality and risk management processes and must rigorously follow them through the full lifecycle of the device. In addition, they must comply with all legislative requirements that apply to their target market. This article summarises what manufacturers must consider ensuring regulatory compliance for their medical device.

Medical Device Compliance: All You Need to Know

In this article, we present some simple guidelines that you can use to navigate through the maze formed by medical device regulations and standards around the world.

Introduction to Medical Device Compliance

Generally, all medical devices must be safe, i.e. contain no unacceptable risks, and they must attain the performance and functionality as declared by its manufacturer. You as the manufacturer must satisfy these “meta-requirements”:

  1. Clearly describe the intended use of the medical device, define the use environment and user profile and keep these consistent.
  2. Once you’ve done that, you need to develop your medical device in compliance with the regulations and standards that apply to your target market.
  3. Only after regulatory bodies have assessed your device and certified its compliance, can you release your device on your target market.

The keyword here is compliance, and in order to be compliant, you need to know which regulations and standards apply to your device. This is not straightforward because the regulations and standards are dependent on your target market.

And so we come to the question that every medical device manufacturer asks at some point: which regulations and standards apply to my medical device for my target market?

In this article, we present some simple guidelines that you can use to navigate through the maze formed by medical device regulations and standards around the world.

 

The Big Picture of Medical Device Compliance

There are three related concepts: regulations, standards and guidelines. Put simply, regulations are legal requirements at a national or international level, standards support regulations and guidelines support regulations and standards.

ArrowFast_scheme_When_Medical_Device_Compliance_All_You_Need_to_Know

Figure 1: Overview of how regulations, standards and guidelines support each other.

Medical Device Regulations

Regulations are formulated at the highest level, usually nationally or internationally (Figure 1), and compliance is maintained by designated regulatory bodies. It is mandatory that you comply with regulations. Regulations tell you what you need to do.

The first rule of compliance is that

it is mandatory that you comply with the regulations of your target market.

The second rule of compliance is

to always use the latest regulations.

Examples of Some Regulations

European Union Medical Device Regulations

In the EU, there are two regulations that apply to medical devices:

  • Regulation (EU) 2017/745 (medical devices)
  • Regulation (EU) 2017/746 (in vitro diagnostic medical devices)

Download our MDR PDF that summarises what you need to know to be MDR compliant.

US Medical Device Regulations

In the United States, the Code of Federal Regulations (CFR) Title 21 regulates food and drugs manufactured or consumed. The regulations relevant to different topics applicable to medical devices are addressed in different parts of CFR 21.

Some examples are:

  • CFR 21 part 800 (General)
  • CFR 21 part 801 (Labeling)
  • CFR 21 part 803 (Medical device reporting)
  • CFR 21 part 806 (Medical devices; reports of corrections and removals)
  • CFR 21 part 807 (Establishment registration and device listing for manufacturers and initial importers of devices)
  • CFR 21 part 808 (Exemptions from federal preemption of state and local medical device requirements)
  • CFR 21 part 810 (Medical device recall authority)
  • CFR 21 part 812 (Investigational device exemptions)
  • CFR 21 part 814 (Premarket approval of medical devices)
  • CFR 21 part 820 (Quality system regulation)
  • CFR 21 part 821 (Medical device tracking requirements)
  • CFR 21 part 822 (Postmarket surveillance)
  • CFR 21 part 830 (Unique device identification)
  • CFR 21 part 860 (Medical device classification procedures)
  • CFR 21 part 861 (Procedures for performance standards development)

Medical Device Regulations in China

In China, there is one main regulation that is effective as of 1 June 2021, but it is supported by a number of other orders and decrees:

  • Order No.739 Regulation on the Supervision and Administration of Medical Devices

Download the flowchart for a summary of the medical device registration process in China.

Medical Device Regulations in Russia

In Russia, there is one main regulation:

  • Resolution N 1416 Adoption of rules for state registration of medical devices

Read the interview with the ArrowFast Regulatory Affairs Manager for more information about the medical device registration process in Russia.

Medical Device Standards

Standards are written by international organizations, e.g. International Organisation for Standardization (ISO) and International Electrotechnical Commission (IEC). Regulations are usually written to refer to standards, either the international versions, or so-called “harmonised” standards.

Therefore, while it is only recommended that you comply with relevant standards, it is usually in your best interests for you to comply with the standard.

While regulations tell you what you need to do standards tell you how you to do it.

The third rule of compliance is that

even though it is only recommended that you comply with standards, it is usually in your favour if you comply with a standard because many regulations refer directly to specific aspects of standards.

International Standards

International standards are technical standards developed by international standards organizations, e.g. like ISO and the IEC, and are available for use worldwide.

Examples of International Standards

Quality Management System and Risk Management

All medical device development requires that a quality management system be established and that there must be management of risks. There are two international standards that apply to these topics:

The fourth rule of compliance is

to establish your quality management system and risk management process up front.

Product-Specific Standards

There are also international standards that apply to specific aspects of your medical device. For example, if your medical device is actually just software that performs a medical function, then it is in your best interests if you comply with IEC 62304 on software life cycle processes.

There are many standards that apply to specific medical devices and it is impossible to list all of them. For example, search for “medical device” on the ISO website 😊 . However, to give you an idea of the kinds of product-specific standards that exist:

  • IEC 60601-1 General safety for medical electrical equipment
  • IEC 62304 Software Life Cycle Processes
  • IEC 62366 Usability engineering
  • ISO 10993 Biological evaluation of medical devices. Evaluation and testing within a risk management process.
  • ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
  • ISO 14155:2020 Clinical investigation of medical devices for human subjects — Good clinical practice
  • ISO 14644-16:2019 Cleanrooms and associated controlled environments — Part 16: Energy efficiency in cleanrooms and separative devices
  • ISO 14708-6:2019 Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)

Harmonised Standards

The standards organization for a region or country is under no obligation to recognize or adopt international standards. In most cases, however, international standards are adopted with slight modifications or limitations to bring them in line with the region’s regulations. These “harmonised” standards are then appropriately named to distinguish them from the international versions.

For example, EN ISO 13485 is the EU harmonised version of ISO 13485.

Medical Device Guidelines

Guidelines are written by independent groups, sometimes internationally, sometimes nationally, with the intent of making it easier to implement the requirements of regulations or standards. The overall intent is to make medical device development more consistent around the world.

The fifth rule of compliance is

to make full use of the guidelines that are available.

Examples of Guidelines

Develop Hand-in-Hand with Regulatory Compliance

Regulatory compliance is often seen as a burden during the medical device development process. However, the earlier in your development process you incorporate the requirements from the applicable regulations and standards, the less time and effort you will require to get your device assessed and certified. This is simply because you will be developing your device following the same requirements that the regulatory bodies will use to assess and certify it.

The additional benefit of including regulatory requirements early in the development process is that you create a culture of regulatory compliance so that it becomes a natural part of the development.

The sixth rule of compliance is

to include regulatory requirements into your development process from the beginning.

Where to find the Regulations, Standards and Guidelines You Need

Unfortunately, there isn’t a one-stop-shop where you can easily find what regulations and standards you need to comply with for your target market. However, there are a few steps that will help you:

  • Identify your target market
  • identify the applicable medical device regulations
  • identify the applicable requirements
  • find any harmonized standards
  • find applicable guidelines

For More Information

As you have seen, it is impossible to list every single standard that is applicable to the development of medical devices simply because there are so many standards that only apply in specific cases.

We have therefore tried to give you a good overview of the methodology that you as a manufacturer should follow in order to get your medical device certified.

Remember, however, that you can always contact us at regulations@arrowfast.tech. Our team of experts would be happy to help you identify what you need in order to get your medical device certified for a specific market.

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ArrowFast Team

ArrowFast Team

ArrowFast Team - A group of Medical Device Engineering Specialists

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