Medical device regulations are no joke. It’s pretty important to get the regulations right, since even a single missed data, if significant enough, can result in years of delay in getting a CE mark.
As such, if you operate in the medical device industry, you must have a good idea about the regulatory framework your device will have to go through. Since there are several in place, getting to know them all takes a bit of time and practice.
We wish it was simple, or even neat. But it isn’t. The documentation required for medical device regulation is all over the place, and keeping track of them can be difficult.
Not to mention that each country may have its own set of requirements, which complicates matters further. However, there are certain important links you absolutely need to save in your favorites tab. In this article, we will go over those links and some websites you need to follow religiously to keep up to date.
EU Medical Device Regulation
The European Union has one of the most complicated regulatory requirements for medical devices. The regulation is known as the Medical Device Regulation (MDR). It covers all medical devices sold in the EU, regardless of their country of origin. So, if you are a US manufacturer, you still might want to keep a tab on the MDR updates. Here are some of the important ones:
This is technically a legal journal. All EU member states follow the laws published here. where you may discover the full text of the MDR and its supporting materials. Plus, any new laws that get posted are also worth checking out.
This webpage gives updates on everything medical device that’s happening within the EU. It also includes necessary information on important directives, new regulations, a list of documents, events, articles, etc. This is one of the most important websites for EU regulatory experts.
EUDAMED, when fully active will be the center of all regulatory functions and conformity assessment procedures. This is a central database to gather and maintain information on medical devices on the market, makers, and authorized representatives. It is currently in development and should be completely operational soon.
The European Commission and the Medical Device Coordination Group (MDCG) give out guidance documents to help manufacturers comply with the MDR. While these aren’t technically legally binding, the Notified body and authorized representative will often expect you to follow them. They also go in pretty deep regarding the regulations and requirements of MDR and give specific details. So, they are pretty important. They also get updated every now and then.
United States (US) Medical Device Regulation
The United States has its own set of medical device regulations, known as the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food and Drug Administration (FDA) enforces these regulations within the US.
This is the FDA’s official webpage for medical devices. It includes almost everything you will need to know about the FDA regulation for medical devices. It has all resources including CDRH info, Device safety info, guidance documents, regulatory requirements, etc. The FDA also has cool step-by-step directions for medical devices that come in handy.
This is a great place to start if you are new to the FDA or want to look up something quick. This page has lots of helpful links. For example, they have a classification page that helps you classify medical devices based on their risk level and the controls required for their safety and effectiveness. This webpage also includes tons of basic info like whether your device qualifies as a medical device or not.
A lot of medical device manufacturers struggle with this step. Medical devices must first go through the 510(k) process, which entails filing a premarket notification to the FDA. This procedure enables the FDA to decide if the device is substantially equivalent to a legally marketed product.
ISO stands for International Organization for Standardization. It is an international standardization authority that works in a lot of fields including medical devices. Some ISO standards specify the requirements for the design, development, manufacture, and installation of medical equipment, as well as the services that accompany them. As they are internationally recognized, almost all countries want you to follow them.
ISO 13485:2016 is compatible with the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). This means that adhering to the standard can assist manufacturers achieve the standards for CE certification, allowing them to market their items in the EU.
Other ISO papers relating to medical devices
In addition to ISO 13485, several other important ISO publications give extra guidelines and regulations for medical device manufacturers. While you don’t have to memorize all of them, they are worth going over a few times.
ISO 14971:2019 Medical devices – Regarding risk management.
ISO 14155 – On clinical investigation (human subjects).
ISO 9000 series – Quality management systems.
ISO 16142-1,2 – Principles of safety and performance of medical devices.
Australian Medical Device Regulation
The Therapeutic Goods Administration (TGA) regulates medical equipment in Australia. Like EU MDR, the TGA also categorizes medical devices according to their level of risk, with Class I being the lowest risk and Class III medical devices having the highest. All medical devices sold in Australia must be on the Australian Register of Therapeutic Goods (ARTG). Here are some documents you should be aware of regarding the TGA.
This is basically the MDR of Australia. It’s pretty standard, so give it a thorough read.
This is a guidance document. They have several versions of it, so make sure to follow the changes as it updates every few months.
Swiss Medical Device Regulation
They usually follow and accept EU certification. However, some web pages are still worth taking a look at.
Swissmedic is the national regulatory authority for therapeutic products in Switzerland. They provide information on the regulatory framework for medical devices.
The FOPH oversees public health matters in Switzerland and may provide information on medical device regulations.