You have the idea, you know how to realize it, you got the necessary finances to get started, .... GO GO GO!
And then you're ready to conquer the world...or not.
Medical devices are heavily regulated in most parts of the world, rightfully so. Even though the ideas are great and the aim is to help patients, you need to make sure you cover and test all aspects of your device. This is why regulators and authorities want you to demonstrate what you have done.
You need to obtain an approval for most devices before you can bring them to the market. Part of the file you create is to explain (and prove) which standards you comply with.
With which standards do you need to comply?
Is there one central database which you can easily search? That would be wonderful, but unfortunately the answer is "no".
However, you're not completely alone in the dark.
On the IMDRF website there is a nice introductory document that gives you an idea about the complexity of standards and where to start looking for answers.
Even though most standards are voluntary, you might soon discover that it's not easy to do things differently and still obtain acceptance. However, in some cases, there are no standards that cover (all) aspects of your device and then you have to resort to alternatives (see IMDRF document).
Also don't forget to look at national requirements. Some regulatory bodies might have specific requirements.
Assuming you are not in that special case of a super-innovative technology for which no standard exists, it's a good idea to do your research on the standards that apply to your device. Even if you would be in that special situation, you still need to investigate which general standards are applicable to your organization or processes.
There are 3 main categories of standards:
- Horizontal: These are standards that are not product-specific. They deal with for example with risk management, usability engineering principles, quality management, etc. They are applicable throughout the set of products or processes you might have.
- Semi-horizontal: These standards are applicable to a group of products with a specific feature in common, for example standards about sterility for sterile devices.
- Vertical: These are product specific standards, for example standards specific for syringes or infusion pumps.
You need to investigate these 3 types of standards for their applicability to your device and processes.
There are different partners involved in the development of standards and standards can be issued at different "levels".
- International: These standards are not linked to any national or regional bodies, for example ISO and IEC
- Regional: These are standards, linked to a region such as Europe, for example CEN
- National: These are standards, developed by a national body, for example BSI (UK), ANSI (US)
Note that the list above are just examples and is definitely not complete.
It will take some time and effort to go through all kinds of organizations and screen for possible applicable standards.
Some standards are recognized by Regulatory bodies.
A good starting point is to look at the databases of recognized standards. Complying with them will make it easier to build your medical device file for market clearance.
In Europe you can find the list of "Harmonised Standards" for medical devices here: https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en
For USA, you can search this database: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm
Not all standards are fully recognized in all countries.
IMDRF published in 2014 a report on recognized standards for its member countries.
This overview slide from the report shows that indeed, depending on the country, recognition of standards might be different:
So what should you do then?
- Know your device. This can sound silly, because you do know what you are building. Make sure you don't forget any aspect. The intended use, the intended user population, the environment where the device is used, etc. It can all have an impact on which standards apply.
- Screen the databases of the main standardization organizations.
- Screen the databases of recognized standards.
- Look at the legislation specific to the target markets as there might be additional requirements described.
- Do your homework early. Some standards affect the design of a device. You don't want to discover that when you are ready to launch your product.
- Make sure your quality management system complies to the regulatory requirements.
- If this all sounds really scary, involve a specialist to get started.
In any case, a good QMS software will help you to make your gap analysis with your selected standards and build your quality manual. Look at our website for more information!