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.
We decided to put together a guideline that you can use to understand and comply with medical device regulations and standards worldwide.
Compliance is key – and in order to be compliant your organization must know which regulations and standards apply to their device. And although it seems straightforward, it’s not, as these vary according to your target market.
Which regulations and standards apply to my medical device and for my target market?
Overview of how regulations, standards and guidelines support each other – There are three, interrelated concepts here – regulations, standards and guidelines. And we will break these down and explain how each is relevant for your company and your target market.
Medical Device Regulations
Regulations are formulated at the highest level, usually nationally or internationally, and compliance is maintained by designated regulatory bodies. It is mandatory that you comply with regulations. Regulations tell you what you need to do.
What are some types of regulations?
European Union Medical Device Regulations
In the EU, there are two regulations that apply to medical devices:
- Regulation (EU) 2017/745 (MDR)
- Regulation (EU) 2017/746 (IVDR)
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 Standards
While regulations tell you what you need to do standards tell you how you to do it.
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 “harmonized” standards.
So, what does this mean? Although it is only recommended that you comply with relevant standards we recommend that you comply – it will be in your best interests.
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:
• ISO 13485 Quality Management System for Medical Devices
• ISO 14971 Risk Management
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.
Medical Device Guidelines
As regulations and standards vary worldwide, guidelines are put into place in order to make medical device development and implementation of regulations and standards more consistent. Guidelines are written by independent groups nationally or internationally.
Examples of Guidelines:
• International Medical Device Regulators Forum (IMDRF) guidance to define the unique device identifier (UDI)
• Various guidance documents published by the Medical Device Coordination Group (MDCG) in the EU.
Develop Hand-in-Hand with Regulatory Compliance
How can you make your development efforts run more smoothly? Although seen as a burden, regulatory compliance is essential for getting your device assessed and certified quicker – 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.
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
So what do you actually need?
There are many regulations standards and guidelines – so how do you navigate through all these?
The above overview and tips will help you understand what you needs as a manufacturer to get approval of your medical device.
But we are always here as well and you can always contact us – we have over 10 years’ experience and knowledge. Our team of experts will be happy to help you identify what you need to get approval of your medical device for a specific market.
