We take for granted that most medical devices on the market have been well tested and are made in modern, safe facilities. But that is not always the case. As a consulting firm, hundreds of companies approach us each year in their quest to obtain the CE Mark for their medical device. Sometimes those "companies" consist of nothing more than one person making a device in his or her garage, with no control over how the product was designed, no monitoring of customer complaints and no written processes regarding how the product is manufactured, stored or tracked. Fortunately, standards such as ISO 13485:2003 provide "best practices" guidance on how products should be manufactured, distributed and tracked. In following this guidance, a large number of unsafe products are prevented from entering the European marketplace.
The Role of Standards
Most people do not even realize how important standards are to their everyday lives. Nearly everything we touch on a daily basis is impacted by the application of standards - the car you drive, the food you eat and the bed you sleep on all were shaped by standards.
It's a good thing we have standards. Before the beginning of the 20th century, not many documented standards were in place. Imagine going to the hardware store today for a replacement light bulb and finding out that there are several different socket sizes, some of which fit into your fixture and others that don't. The fact that all ordinary light bulbs and sockets all fit together, regardless of manufacturer, is no accident.
Standards are established by several national and international organizations. Some of the most well known include the International Organization for Standardization (ISO), American Standards for Testing of Materials and European Committee for Standardization, known by its French acronym, CEN. A list of harmonized standards for the medical device industry is published in the Official Journal of the European Union. I won't bore you with how standards are created or how these organizations work together because that would fill an entire article by itself.
Standards can be described as vertical or horizontal, depending on how broad they are. A vertical standard is specific to a device, and a horizontal standard applies to a wide range of devices. Examples of common horizontal standards are ISO 13485 and ISO 14971. An example of a vertical standard is ISO 7197:2006, which deals with neosurgical implants. Following is a brief discussion about the horizontal standards most often applied to medical device companies.
ISO 13485:2003 - Quality System
This is the 800 lb gorilla of the device industry. ISO 13485 was adopted in Europe in 1996 and is a modified version of ISO 9001 - but with additional requirements especially tailored for the medical device industry. Most people believe that ISO 13485:2003, and many standards in general, is a requirement, but this is not true. It is voluntary in the context of the European directives for medical devices. It is true that you are required to meet the quality system requirements outlined in the directives (Annex II and Annex V specifically), but how you are going to meet those quality system requirements is left to you. ISO 13485 is a voluntary tool available to you to meet the quality system requirement, and there are a number of really compelling reasons to apply ISO 13485.
First, although ISO 13485 is voluntary, it is considered the "de facto" standard for companies that sell medical devices in Europe. If you do not follow ISO 13485, most find it challenging to implement and meet the quality system requirements outlined in the Medical Device Directive (93/42/EEC), In Vitro Medical Device Directive (98/79/EC) or the Active Implantable Medical Device Directive (90/385/EEC). In other words, if you are in compliance with ISO 13485:2003, you are presumed to be in compliance with the quality system requirements of these directives. Second, why reinvent the wheel? ISO 13485:2003 is designed especially for medical device companies. Third, ISO 13485: 2003 is recognized worldwide, and your certification automatically improves the perception of your company and its products.
Canada, Australia and other countries outside Europe also recognize ISO 13485:2003, but the US FDA does not. The US system of Good Manufacturing Practices predates the development of ISO 13485 and, therefore, the US FDA follows its own system. However, both quality systems have many overlapping elements.
Keep in mind that standards are not permanent and often are updated (eg, ISO 13485:1996 was updated to ISO 13485:2003) or withdrawn altogether (eg, ISO 13488 was withdrawn and replaced by ISO 13485).
EN 60601 - Electric Safety
Any medical device company that makes a device with an electrical component knows about EN 60601 series. This standard deals with electrical safety and electromagnetic compatibility (EMC). Generally, to meet the requirements of this standard, you will have your device tested by test laboratories. If your device passes a series of rigorous tests, it is deemed in compliance with the standard and you will receive a report that states "pass" (instead of "fail," the only other statement you could receive).
There are alternatives in which companies buy CE Marked components, assemble the product in accordance with the component manufacturer's instruction and then draft a "technical" justification on why they believe the system/device as a whole complies with the EMC and/or electrical safety requirements of the directive. This compliance route tends to be challenging and requires in-depth knowledge of the standard as well as electrical safety and/or EMC in general. While each CE Marked component may be compliant, how do you know the system as a whole is compliant? Anyone who has ever used a computer knows that conflicts can occur when a new component (software) is added to a system. That's why it is better to be safe by ensuring your device is compliant in its assembled state and have it tested in accordance with the applicable standards.
EN 980 - Use of Symbols on Labeling
On a continent with more than 25 official languages, communicating through symbols is imperative and EN 980 is the standard for use of symbols on medical devices. In this case, the standard lays out the acceptable visual representation of concepts such as "Expiration Date," "Maximum Temperature Allowed" and "Date of Manufacture." Harmonized symbols are meant to enhance consumer protection and allow for communicating important concepts quickly to the user. They also relay vital information on labeling where space is scarce and there is no room for written directions, warnings and cautions.
ISO 14971 - Risk Management
How do you know that your device will perform as expected? What if it does not? What are the consequences? These are a few of the very important concepts addressed in ISO 14971 pertaining to risk management for medical device companies. ISO 14971, as all the other standards mentioned above, is voluntary. However, if there is an incident involving your device and a patient is injured or dies as a result, do you think you might get sued? Do you think the plaintiff's attorneys might look to see if your company had a systematic process in place to evaluate product performance and potential hazards? You bet. ISO 14971 sets a formal process for dealing with risk and focuses on how your company can produce safer products.
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Standards serve a very important role in the device industry because they encourage consistency, enhance safety and improve efficiency. While their use is voluntary, companies employ them to their advantage and do not think of them as a burden. Always remember, if Harmonized European Standards are applied within the context of meeting an essential requirement of the directive, there immediately exists the presumption of conformity to these requirements. So why not apply them?