Before a medical device can be legally marketed in most countries it must be approved by a regulatory body. In the US, marketing approval is granted by the FDA. According to the FDA, Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval. In the majority of cases devices are submitted via the 510(k) route.
In Europe the device must receive a CE mark before it can be marketed. The CE mark is granted by a Notified Body which grants its approval based on documents submitted and an inspection visit. As with the FDA process, devices are classified into different categories based mainly on the potential danger that they may pose to patients.
If you’d like a deeper explanation of regulatory processes there are several excellent sites on the web that describe both the European and American regulatory systems.
As a freelance technical writer you may be called upon to write a User Manual or Instructions for Use (IFU) for a medical device. As most of you are aware, there is regulatory aspect to the writing of a medical device manual. The manual must be filed together with many other documents to receive marketing approval in the US, Europe and many other countries. This series of posts will help you to work with regulatory experts in producing a regulatory-compliant manual and keeping it in compliance.
I’d like to stress that, as I wrote in the previous paragraph, the person who is ultimately responsible for ensuring that the manual is written correctly from a regulatory standpoint is the either the regulatory consultant hired by the company or the company’s in-house Regulatory Affairs Director.
The following posts will get into more specific details about how to write a regulatory compliant manual..