Packaging and User Manual for Medical Device and Accessory

J

Jonas Wistrand

Hello Everybody!

We are developing a Class IIa product (ref: A) and an accessory (ref: B) to that product. Both of them classed after their own merits.

Product A does not work without B and vice versa. The reasoning for having them separate is that A has a lifetime of 2+ years while B will likely breake within a year. We would hence want to sell B as an accessory to A.

The system (A+B) is called, modified for the sake of discussion, Product 100. Product 100 (full system) is hence built up by: Product 100 - A & Product 100 - B.

Is it OK to make a single user manual with the name: Product 100 ?
We would then inside of the user manual explained what Product 100 consist of and how to order "spare parts", i.e. Product 100 - A or Product 100 - B.

If we want to sell B separate, can the package contain Product 100 user manual? In other words, not a manual specifically made for B, but for A+B.

What about packaging of the system, can we have a CE-mark on the package that contains A and B?

I realized that I made it a little bit messy, but I hope that you get the picture. Very thankful for any guidance.

Note: This is a question regarding CE-marking for introduction in Sweden only (so all translation issues etc. regarding user manuals can be disregarded).

Regards,
Jonas
 
S

SteveK

Hi Jonas,

I do not see any problem in just having one single user manual/IFU (for Product 100), in fact if the ‘accessory’ is simple you do not necessarily need to supply a further IFU – see:

13.1 (Annex I)

“Instructions for use must be included in the packaging for every device.
By way of exception, no such instructions for use are needed for devices in Class I or IIa if they can be used safely without any such instructions.”

However, if you wish to include the joint instructions just for item B again I do not see any problem.

Also I cannot see any reason for not placing the CE mark on the packaging for A+B or just B. You will have created a TF for the combination, but B will be classified as a medical device in its own right and therefore it is covered by the overall certification.:2cents:

Steve
 
J

Jonas Wistrand

Thanks a lot Steve!!!

Will go for separate User Manuals.

Regards,
Jonas
 

shrutisancheti

Starting to get Involved
Dear All,

Please inform if there is any specific guidance document(s) explaining the essential contents of the user manual/operator manual/service manual for a medical device to be marketed in Europe.

Thank you in advance.

Best regards,
Shruti
 
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