What are the limits on manufacturing changes and substantial changes?

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#1
What are the limits on manufacturing changes and substantial changes?

Additional line of production under the same QMS and same building?

Different buildings on the same campus?

Differing addresses on the same campus?
 
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planB

Super Moderator
#2
Ed,

I would say, all 3 examples you are mentioning are _not_ beyond limits re. manufacturing changes. Discussing the intended change with your notified body certainly helps.
 

planB

Super Moderator
#4
Ideally, there are supplier contract and specifications in place that require the contract manufacturer to notify and seek approval by the legal manufacturer prior to implementing the requested change.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#5
Found this MDD for NBOG

Changes that are substantial
b) of changes to EC-approved quality systems (MDD Annex II.3, V, VI; IVDD Annexes IV and
VII respectively):
· Change of a critical material supplier; critical component/process subcontractor
· A change in the manufacturing process whereby a new technology is introduced
· Buying a product design from a subcontractor, that falls within the manufacturers own
approved product range, but which was not designed under the manufacturer´s own
design control system
· Making substantial changes to the sterilization process/cycle that would necessitate a
full new validation (e.g. going form EtOH sterilization to gamma sterilization)
· Changing the sterilization contractor
· Building a new clean room or changing an existing cleanroom’s classification
· Making substantial changes to the environmental monitoring program or then environmental
control systems
· Moving a production line from in-house to an outside facility (manufacturer´s own or a
contractor); introducing a production line into manufacturer´s own facility from an outside
facility
 

planB

Super Moderator
#6
Ed,

if you are looking for a decision tree for assessing whether a change has to be assessed as being significant (and thus, has to be submitted to your notified body), this is quite complex these days for MDD/AIMD devices due to the MDR transition period until May 26 2021.

Depending on the nature of your change NBOG 2014-3 or MDCG 2020-3 may apply.

Hope this helps,
 

RobertvanBoxtel

Involved In Discussions
#7
If the identified changes are done with regard to MDD/AIMDD certified products, the referenced NBOG 2014-3 should be used to determine notification and NB approval requirements.
However, per Date of Application (DoA) - May 26, 2021 - everything changes. The Commission has written a guidance document how Article 120.3 should be applied by manufacturers and NB's for products falling under not yet expired MDD/AIMDD certificates.
Additionally, for MDR compliant products, the requirements on change notifications in that Regulation will become relevant.
And always, please check your contract with your NB. There you might find some additional notification requirements, on top of mentioned documents.
 
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