Change in Lot Release Specifications - Definition of "Substantial Change"

J

JB0424

Starting to get Involved
#1
#1
Hi all.

I am seeking information on when a change to a class III device is considered substantial, and therefore requires notification to my notified body.

I have a product that has changes in some specifications for lot release, but not performance specifications. The specifications in question are important because they dictate our ability to meet performance specs at time of use and shelf life.

The lot release specifications are being relaxed from where they currently are. I suspect this will likely need to be sent as a notice of change to my notified body, but I cannot find any guidance documents defining when a change is substantial and notification is required. Is anyone aware of documents that offer guidance in this decision?

Thanks!
 
Paper to QMS ad
Elsmar Forum Sponsor
J

JB0424

Starting to get Involved
#4
#4
Re: Change in lot release specifications - substantial change?

Thank you for the response. The guidance appears to be for Canada. Is this applicable to EU as well?
 
MDD_QNA

MDD_QNA

Involved In Discussions
#7
#7
Re: Change in lot release specifications - substantial change?

Is the change also a significant change if we didn't file the tolerance specification to the authorities? However, the actual value has been submitted to the authorities and the tolerance is written in the Final Inspection testing and it is a crucial parameter for us.
 
C

Chrisx

Involved In Discussions
#9
#9
Page 9 of the NBOG guidance states:

"Changing a test acceptance criterion or test method or removal of test acceptance criteria, inprocess inspection, or final inspection is considered substantial (5.1 only)."

5.1 of the guidance is for product changes.
 
M

maxximase

Registered
#10
#10
amjadrana said:
For the Notified body see the following document: NB-MED-2_5-2_Rec2_Reporting of design changes and changes of the quality system

Amjad Rana
Click to expand...
Chrisx said:
I think the notified bodies are supposed to apply this guidance: NBOG_BPG_2014_3 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System.pdf
Click to expand...
So both the NB-MED and NBOG documents cover the same topic, but I have not yet performed a line by line gap analysis to see if the requirements vary at all. How do we know which of these documents takes precedence?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
J PMA Device - Lot # change in New ERP Software - What are the FDA Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
J Change Lot Acceptance Level to one on all plans - Any code of practice? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
Q Change the shape of the raw material FAI AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D Engineering Change Order (ECO) metrics to track ISO 13485:2016 - Medical Device Quality Management Systems 6
P Notified Body Approval of Change EU Medical Device Regulations 2
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 6
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
G Need to change KPI we called NC parts (maximum 3%.) to FTQ (first time quality) IATF 16949 - Automotive Quality Systems Standard 4
J FDA notification of address change US Food and Drug Administration (FDA) 2
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
D List A IVD - Change to material supplier EU Medical Device Regulations 3
R Change Management vs Opportunity for Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Is There a Revision History or Change Log for Canadian Regulations? Canada Medical Device Regulations 3
C Brazil - Product Code (and brand) Change Other Medical Device Regulations World-Wide 0
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
R Change Notification - Registrar vs Notified body ISO 13485:2016 - Medical Device Quality Management Systems 1
Marc Insects and Climate Change - 2020 World News 0
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q Company Ownership Change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
I Is highlighting on a printed document considered a change? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
N China - Start manufacturing before change approval? China Medical Device Regulations 1
L 510K - Trade Name Change 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
D Change Control - Product Name Change and its associated labeling EU Medical Device Regulations 7
K Is a change that fixes a recalled device significant? Medical Device and FDA Regulations and Standards News 2
L Significant change notice for outsourced warehouse Medical Device and FDA Regulations and Standards News 2
U Change Management vs Change Control? Design and Development of Products and Processes 4
H New 510K VS Documents about design change. Other US Medical Device Regulations 1
P Change on Medical Device Classifications - Dental Crowns Other Medical Device Regulations World-Wide 2
D Are medical device companies required to document every change made to their website? Document Control Systems, Procedures, Forms and Templates 2
Ed Panek Relevant questions on Substantial Change Form CE Marking (Conformité Européene) / CB Scheme 3
K Reporting a Change of Contract Manufacturer for a 510(k) cleared device Other US Medical Device Regulations 5
R Software change control process and defect tracking ISO 13485:2016 - Medical Device Quality Management Systems 1
S Device name change and label color change EU requirement? Other Medical Device Regulations World-Wide 6
M CBE (Change Being Effected) 510(k) Submission Other US Medical Device Regulations 2
D Customer and Company Specific Requirements for notification of Customers of a change in Management or Key Personnel Customer and Company Specific Requirements 3
R Explain what "design change" is to people new to the industry ISO 13485:2016 - Medical Device Quality Management Systems 9
S Change value of target during a batch Capability, Accuracy and Stability - Processes, Machines, etc. 0
T Change in BRH (Brazilian Registration Holder) Technical Manager Other Medical Device Regulations World-Wide 2
G Saline solution change for soft contact lens potting CE Marking (Conformité Européene) / CB Scheme 0
M How to implement the 4M Change Management System Lean in Manufacturing and Service Industries 3
Ed Panek Is Shelf Life Change a significant change? CE Marking CE Marking (Conformité Européene) / CB Scheme 7

Similar threads

Top Bottom