Class IIa Medical Device Technical File - Annexes

tebusse

Involved In Discussions
#1
Hi Everyone!

I am currently in the process of researching the requirements for CE marking my company's class IIa medical device. I understand that we can follow either Annex II or Annex VII.

However, if we select to follow Annex VII (which is the way we'll go) are we required to complete the other three Annexes associated with class IIa (i.e. Annex IV, V, VI)?

Or, do we complete just Annex VII and one of the other Annexes (IV, V or VI) to demonstrate conformity with the MDD and ER?

Regards, Tonia
 
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Ronen E

Problem Solver
Staff member
Moderator
#3
Hi Everyone!

I am currently in the process of researching the requirements for CE marking my company's class IIa medical device. I understand that we can follow either Annex II or Annex VII.

However, if we select to follow Annex VII (which is the way we'll go) are we required to complete the other three Annexes associated with class IIa (i.e. Annex IV, V, VI)?

Or, do we complete just Annex VII and one of the other Annexes (IV, V or VI) to demonstrate conformity with the MDD and ER?

Regards, Tonia
Hi,

In very rough terms:

You must follow annex I and VII.
On top of it, for a class IIa device you must follow either annex IV or VI.
You may follow annex V or II instead of annex VI, but these represent a broader requirement scope for your QMS.

Cheers,
Ronen.
 
R

Ron Boumans

#5
See Medical Device Directive 93/42 article 11:
For class IIa:
- Annex VII plus Annes IV, or Annes V or Annex VI, or:
- Annex II without paragraph 4.

Of course Annex I should be applied too.

The choice for the exact procedure depends on the device and the way the company is organized. If I see a company that has made a 'strange' choice it triggers me to look closer at that organization. You may want to consult your notified body.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
In these difficult times I see nothing strange in organizations taking the most economical path legally available to them. Out of the 3 QMS paths - annex II, V & VI - annex VI is the easiest and there is nothing wrong with an organization choosing this path if their highest device class is IIa, given that they comply properly and thoroughly.

Of course, if they want to excel and have the right resources, they could follow annex II or V, as follows:
Annex VI - for organizations that mostly outsource production processes
Annex V - for organizations that have significant in-house production, with no Design and Development processes
Annex II - for organizations that need a comprehensive QMS, including in-house production and Design & Development

Cheers,
Ronen.
 

tebusse

Involved In Discussions
#7
My company manufactures software (PACS) and our production is in-house and we do have significant design and development. I'm figuring the best route to conforming with the Directive is to follow Annex II.

Thank you for you help!
 
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