Are medical device companies required to document every change made to their website?

[Darshan_Shetty]

We are manufacturer of a Class IIa medical device, marketing in US as well as EU. Our current QMS system is paper based. The current practice in the company is to document every change made to the website even if its not directly related to the IFU such as blogs and marketing activities. I am not sure if this required and if it is, please point me to the applicable regulation.

Also If it is required, how are paper based QMS companies managing it? How are eQMS companies managing it?

 

[yodon]

My take has always been that if the content is considered labeling (e.g., contains claims, etc.) then it has to be controlled. You can readily segregate content that requires control from content that wouldn't be considered labeling and the non-labeling pages need not be controlled.

Blogs are, IMO, the riskiest area since it's easy to cross the line from uncontrolled to controlled. You just need to take care and review before posting.

It's certainly not a bad idea to review all materials / changes before posting to ensure it doesn't cross the line.

 

[Ed Panek]

Make all references to claims and controlled statements as linked PDFs. This way only the linked PDFs need to be reviewed.