Exclusion of Design and Development Controls for Class 2B Medical Devices

somashekar

Staff member
Super Moderator
#1
Does the EU regulatory permit exclusions of design and development controls for a Class 2B medical device ?
Kindly help me with a reference where this is cited...
:thanx:
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: Is exclusion of Design and Development Controls permitted for Class 2B Devices ?

Hi,

According to the MDD, for a class IIb conformity assessment you could apply either annex III + annex VI (or V), or annex II (exc. point 4). The QMS required by the former (either annex VI or V) doesn't require D&D controls. However, if one goes by annex II then D&D controls are required.

Cheers,
Ronen.
 
Last edited:

somashekar

Staff member
Super Moderator
#3
Re: Is exclusion of Design and Development Controls permitted for Class 2B Devices ?

<snip> According to the MDD, for a class IIb conformity assessment you could apply either annex III + annex VI (or V), or annex II. The QMS required by the former (either annex VI or V) doesn't require D&D controls. However, if one goes by annex II then D&D controls are required. <snip>
So, will I be correct, if I say that a Company A which has CE for several Class 2B devices vide Annex II, splits up and the D&D process becomes a separate named and registered D&D business center, the route for CE can no more be the Annex II for Company A.
Company A cannot outsource the design also since all the competent personnel responsible for design approval are no more in Company A, and no new design competency is built in, to approve a new design / change in design.
This is a substantial change and the CE route stands effected.
The choice is only Annex III + ...
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: Is exclusion of Design and Development Controls permitted for Class 2B Devices ?

Annex II, 3.2:

Application of the quality system...
... shall include in particular an adequate description of:
(a) ...
(b) the organization of the business and in particular:
-- ...
-- ...
-- where the design, manufacture and/or final inspection and testing of the products, or elements thereof, is carried out by a third party, the methods of monitoring the efficient operation of the quality system and in particular the type and extent of control applied to the third party;
I take it as allowing outsourcing of design activities to a third party, subject to adequate
(1) QMS efficiency monitoring means, and
(2) control over such party.

Cheers,
Ronen.
 
Last edited:

somashekar

Staff member
Super Moderator
#5
Re: Is exclusion of Design and Development Controls permitted for Class 2B Devices ?

Annex II, 3.2:

I take it as allowing outsourcing of design activities to a third party, subject to adequate
(1) QMS efficiency monitoring means, and
(2) control over such party.
In real business sense, Company A now has no D&D competency. It has to look up for any and all changes to the new D&D business center for effecting changes and approval of same. There may be no new design, but the CE mark devices design sustenance is out of scope practically. Can Company A be still design responsible and outsource ?
In a MDD continual assessment situation, can TCF review be directly taken up by the D&D centre. How will the NB react to this ?
 
R

Ron Boumans

#6
Re: Is exclusion of Design and Development Controls permitted for Class 2B Devices ?

Within the MDD it is possible to outsource almost anything. The final responsibility remains by the manufacturer and therefore he needs to prove the outsourced activities are carried out well. As long as you keep this in mind, the legislation and standards make sense.
 

Ajit Basrur

Staff member
Admin
#7
Re: Is exclusion of Design and Development Controls permitted for Class 2B Devices ?

Ron is spot on ... You can outsource design activities
 

somashekar

Staff member
Super Moderator
#8
Re: Is exclusion of Design and Development Controls permitted for Class 2B Devices ?

Within the MDD it is possible to outsource almost anything. The final responsibility remains by the manufacturer and therefore he needs to prove the outsourced activities are carried out well. As long as you keep this in mind, the legislation and standards make sense.
So can I understand that:
Design and development process outsourcing in the ISO13485 parlance IS NOT SAME AS Design carried out by a third party in MDD parlance ?

Into my next question:
Can my ISO13485 QMS be with Design and development exclusion, and I am manufacturer of class 2b medical devices that have CE mark ?
 

Ronen E

Problem Solver
Staff member
Moderator
#9
Re: Is exclusion of Design and Development Controls permitted for Class 2B Devices ?

Can my ISO13485 QMS be with Design and development exclusion, and I am manufacturer of class 2b medical devices that have CE mark ?
I have 2 optional answers, both in the EC regulation context:

1. Yes. If you implement annex III + either annex V or VI, your QMS doesn't have to have D&D controls.

2. Not formally, but yes in practice. If you implement annex II, your QMS has to have a D&D section, however, this section can shrink down to practising adequate controls over your outsourced D&D.

Cheers,
Ronen.
 
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