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Design and Development Requirement - MDSAP Audit Finding


Starting to get Involved
Hi all,
I work for a company that has no design and development files (they've been making same product with no changes for 50+ years - Lead aprons, dental xray film, etc.). We just had MDSAP audit under Annex II of MDD, so these files were expected. In my initial response I said we would remove the requirement from the scope of the audit - but was told:
"The company decision to exclude the device is not sustained based on the regulatory requirements about design process => do all countries regulations allow to exclude design for all potential device classifications. What impact will this decision have on the actual or expected certificates ?"

My updated response proposal:
Design and development will be excluded from the scope of the quality management system and we request to receive CE certification under MDD Annex V (not II) which should have been initially requested. The design and development is excluded because there are no design activities performed on the devices. The devices are grandfathered/ legacy devices and there are no design changes.
Brazil and Australia will be removed from scope and we will not sell to these countries.

All of our devices in US are class I and only the intraoral film is a Class IIa in EU (and Australia I believe).

My question is does this seem acceptable, does only Brazil and Australia REQUIRE this??
Am I missing any type of exception or technicality based on the type of product?

Thanks I really appreciate it!



Staff member
Super Moderator
Impact on certificate is No Certificate.
Grandfathered or Legacy devices, no issues., but you are responsible for the design and must have your design development records. Make one.
Your updated response will not be sustained.

Ronen E

Problem Solver
Staff member
Super Moderator
Technical files are required for all devices (including class I) under the MDD, regardless of conformity assessment route (Annex II, V etc.). See Annex VII.
Some class I device types require design control in the US (refer 21 CFR 820.30). All devices require a DMR.


Starting to get Involved
Yes good points, I see Annex VII and what is required for DoC, I think we have them all. I'm not certain it's so cut and dry though.

We do have a DMR basically, it's just not called a "DMR". Easy fix on name. We do have technical files as we know this is required (Product descriptions, specs, IFUs, materials, etc., all of the required items.

I guess what we are missing is: Design Input / Output, Design Control, Design Verification, Design Validation type data specifically.
And design control as we don't change them. Product History is missing too as the data for that is very old.

I guess it's doable to create this and use it going forward as the corrective action.
As far as 21 CFR 820.30 I did see this and we are OK without design.

And as far as Annex V...
"Annex V has similar quality management system requirements to Annex II, but the main difference is that Annex II includes design requirements and Annex V does not. For Annex V conformity assessments, the manufacturer needs to have a quality management system for the manufacturing and final inspection for the devices, but there is no requirement that a design system is included. As a result, there may be no design history file to include in the manufacturer’s technical documentation.
However, even if there is no DHF, this conformity assessment includes a technical documentation review."

That is from GMED. Which would imply we would be good for EU (as technical documentation is our TF).

Is it not conceivable to ask for our CE marking under Annex V then?

Annex VII (which is in regards to declaration of conformity) says:
Class I
This route is self-declaration or self-certification and is described in Annex VII Module A, EC Declaration of Conformity. The manufacturer ensures and formally declares, via a written statement, that the products meet the applicable provisions of the Directive.
Class IIa
The manufacturer declares conformity with the provisions of the Directive and Regulations (Annex VII) and ensures that the products comply with relevant essential requirements. However, for Class IIa products, this declaration must be backed up in all cases with conformity assessment by a NB using Annex II, IV, V or VI. WE HAVE THIS

These are the only 2 classes we manufacture.

Thanks for input somashekar and Ronen E. I appreciate it!

Ronen E

Problem Solver
Staff member
Super Moderator
Is it not conceivable to ask for our CE marking under Annex V then?
You can definitely try your luck with your NB and see what comes back.
I wonder though how you'd be able to demonstrate full compliance with the ERs without having documented verification and validation on file.
Do you have RMFs?
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