Substantial Change to QMS (Annex IX, Chapter I)

adir88

Involved In Discussions
#1
Hi,

Is anyone aware of what constitutes as a substantial change defined in Annex IX, Chapter I of the Regulation?

2.4 The manufacturer in question shall inform the notified body which approved the quality management system of any plan for substantial changes to the quality management system, or the device-range covered. The notified body shall assess the changes proposed, determine the need for additional audits and verify whether after those changes the quality management system still meets the requirements referred to in Section 2.2. It shall notify the manufacturer of its decision which shall contain the conclusions of the assessment, and where applicable, conclusions of additional audits. The approval of any substantial change to the quality management system or the device-range covered shall take the form of a supplement to the EU quality management system certificate.
For the MDD, I am aware that this was explained in NBOG 2014-3 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System.

MDCG 2020-3 defines "significant change" in the context of Article 120 (legacy MDD devices). Although the principles for changes to device design apply, the MDCG does not include anything regarding changes to the QMS (expected as Article 120 is in Annex II which is on Technical Documentation).

I am wondering what criteria people are using to determine if QMS changes are substantial per the MDR?

Many thanks.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
Ed Panek Notified Body Substantial Change MDD EU Medical Device Regulations 1
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
Ed Panek Relevant questions on Substantial Change Form CE Marking (Conformité Européene) / CB Scheme 3
W Informational MDSAP Substantial change / Change of notice forms Document Control Systems, Procedures, Forms and Templates 2
C Substantial Change in MDSAP Audit Other Medical Device Regulations World-Wide 1
J Change in Lot Release Specifications - Definition of "Substantial Change" EU Medical Device Regulations 14
E Is Shelf Life extension a substantial change? EU Medical Device Regulations 6
Ed Panek What are the limits on manufacturing changes and substantial changes? EU Medical Device Regulations 6
D Proving Substantial Equivalence in Software Medical Devices Design and Development of Products and Processes 2
K Substantial Equivalence Predicate Device Testing Other US Medical Device Regulations 1
M Medical Device News FDA News - 14-09-18 - Benefit-Risk Factors to Consider for Substantial Equivalence Other US Medical Device Regulations 0
N Substantial or non-substantial modification in clinical studies EU Medical Device Regulations 1
B 21 CFR 803 Definition for 'Substantial Harm" Other US Medical Device Regulations 1
K ISO 10993 Requirements For 510k - Substantial Equivalence Other US Medical Device Regulations 11
S Finding a substantial Equivalent Medical Device Other US Medical Device Regulations 4
P FDA - Evaluating Substantial Equivalence in Premarket Notifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
T FDA 510k Submission - Section 012 SE (Substantial Equivalence) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
G A question on Substantial Equivalence (SE) ? Other US Medical Device Regulations 1
C Statistical Analysis to Demonstrate Substantial Equivalence to the FDA Other US Medical Device Regulations 5
J The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Substantial Equivalence for Laser Wavelength - Class 2 Aesthetic Product Various Other Specifications, Standards, and related Requirements 2
K Procedure for Categorising Substantial Changes to Design CE Marking (Conformité Européene) / CB Scheme 4
M Demonstrating Substantial Equivalence - Requesting 510(k) data from company 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
0 Complaints time series significant change Customer Complaints 41
N Malaysia Shelf Life Change Other Medical Device Regulations World-Wide 2
P Self Certified Class 1 MDR 2017/745 Design Change CE Marking (Conformité Européene) / CB Scheme 2
O Article 120 - significant change interpretation EU Medical Device Regulations 4
V Would the customer drawing change necessitate re-PPAP of the Product? APQP and PPAP 3
S Do we have to create a new PPAP to our customer if our Sub Contractor had to change? APQP and PPAP 10
M PMA submission change Medical Device and FDA Regulations and Standards News 0
U Change to the manufacturing Date for a device in the field US Medical Device Regulations 0
F Change in address for critical supplier - does NB need to be informed? CE Marking (Conformité Européene) / CB Scheme 20
K Change in address on ERLM US FDA: Implications to import US Medical Device Regulations 0
N Change our Registrar? Pros and Cons ? Registrars and Notified Bodies 5
F Using non-randomized clinical study for change in existing 510(k) device? US Food and Drug Administration (FDA) 1
FuzzyD ISO 13485 change in process ISO 13485:2016 - Medical Device Quality Management Systems 3
R IVD Label Change China Medical Device Regulations 1
Judy Abbott Change of PVC stabilizer Japan Medical Device Regulations 6
R IVD Label Change Requirements Other Medical Device Regulations World-Wide 0
M EE's - Laptops/Printer Change and Emissions Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
D Document Change Approval ISO 13485:2016 - Medical Device Quality Management Systems 6
mtmt70a Change\ my MTBF Prediction SW Tool from the RELEX tool with yearly Lic. access Telecordia database to another solution. Recommendations? Reliability Analysis - Predictions, Testing and Standards 0
S Can a product option change the product class? CE Marking (Conformité Européene) / CB Scheme 2
M Regulatory Change assessment US Food and Drug Administration (FDA) 3
G Software change management Design and Development of Products and Processes 3
J Changes to OS - Significant change under MDR EU Medical Device Regulations 8
A If document coding is change will there be a revision Document Control Systems, Procedures, Forms and Templates 1
G Change Control for Test Samples Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
Z Change color or shape of individual data point in control chart Using Minitab Software 6
J Medical Device Component Change - Testing, Sampling Criteria ISO 14971 - Medical Device Risk Management 3

Similar threads

Top Bottom