SBS - The best value in QMS software

Change Notification - Registrar vs Notified body

Racky

Registered
#1
Hi All,

We have an ISO 13485 certificate for sub-component manufacturing issued by a notified body (A; Registrar in this case), whereas the FQA and EC certificate for class III device is issued by another notified body (B) for the finished device. The FQA contains the sub-component manufacturing site listed and the Notified body B has also issued us the ISO 13485 cert for the finished device manufacturing site. We did a substantial manufacturing process change at the sub-component manufacturing site (ISO 13485 cert issued by Notified body A). However, this was a not a quality system change and falls under Annex II, Section 4.4. We notified the substantial change to notified body B since they issued us the EC certificate and FQA.

DO we need to notify this change to the registrar (Notified body A) as well ? They have not issued us a EC cert or FQA.

Thanks
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Hi All,

We have an ISO 13485 certificate for sub-component manufacturing issued by a notified body (A; Registrar in this case), whereas the FQA and EC certificate for class III device is issued by another notified body (B) for the finished device. The FQA contains the sub-component manufacturing site listed and the Notified body B has also issued us the ISO 13485 cert for the finished device manufacturing site. We did a substantial manufacturing process change at the sub-component manufacturing site (ISO 13485 cert issued by Notified body A). However, this was a not a quality system change and falls under Annex II, Section 4.4. We notified the substantial change to notified body B since they issued us the EC certificate and FQA.

DO we need to notify this change to the registrar (Notified body A) as well ? They have not issued us a EC cert or FQA.

Thanks
Good day Racky, I am sorry for the delay in this response.

Can you please describe your "substantial manufacturing process change at the sub-component manufacturing site" and why you feel it is not quality system change? Is your sub-component manufacturing site included in your main certificate as a support site?

This is a question for your registrar, who would have a contract with you that likely includes terms of when you would be required to notifiy them of changes.
 
Thread starter Similar threads Forum Replies Date
J FDA notification of address change US Food and Drug Administration (FDA) 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
supadrai Informational Japan Minor Change Notification Application Form - Found it? Japan Medical Device Regulations 0
S Change Control Form vs. Document Change Notification ISO 13485:2016 - Medical Device Quality Management Systems 3
A Customer Notification of Change Procedure Quality Manager and Management Related Issues 1
A Temporary Change of Manufacturing Site - Notified Body Notification Requirements EU Medical Device Regulations 3
A Material Grade Change Notification to Brazil ANVISA Other Medical Device Regulations World-Wide 2
M Class I Medical Device - 1st notification and change notification EU Medical Device Regulations 4
S Update on Change Notification for Registered Medical Devices in Singapore Other Medical Device Regulations World-Wide 0
B Process Change Notification (PCN) form to notify our customers of a change Document Control Systems, Procedures, Forms and Templates 3
J Complying with Change Notification Requests - Wholesale Distributor Quality Manager and Management Related Issues 7
F Notification of Change of Material Supplier - PPAP Manual 4th Edition APQP and PPAP 15
S Customer PPAP notification and submission for a Change APQP and PPAP 2
J Supplier Change And Customer Notification IATF 16949 - Automotive Quality Systems Standard 1
L Notification of supplier change to our customers Supplier Quality Assurance and other Supplier Issues 2
Q Time change via change of Time Zone Qualification and Validation (including 21 CFR Part 11) 3
T IEC 60601-1-8:2020 Is it necessary to change the alarm melody? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
U Power supply - Change From 160 to 300 Watts - Significant change? EU Medical Device Regulations 2
N Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
M Label change - 510(k) Medical Device and FDA Regulations and Standards News 5
M EMS change management ISO 14001:2015 Specific Discussions 2
E Document Change Request forms (or no forms)? ISO 13485:2016 - Medical Device Quality Management Systems 9
J Significant change related to design and intended use EU Medical Device Regulations 2
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Cleaning process center change ISO 13485:2016 - Medical Device Quality Management Systems 4
U NOC - What is considered a "design change" EU Medical Device Regulations 5
qualprod What do CB´s change when doing a partial moving ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Y Algo change significancy Medical Information Technology, Medical Software and Health Informatics 3
Revision36 Engineering Change Order Industry Standards Other Medical Device and Orthopedic Related Topics 4
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 12
D ECO (Engineering Change Order) process questions ISO 13485:2016 - Medical Device Quality Management Systems 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
Tagin Template or Checklist for Process Change Document Control Systems, Procedures, Forms and Templates 5
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
M Change management procedure when 7.3 is not applicable ISO 13485:2016 - Medical Device Quality Management Systems 5
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
Q Change the shape of the raw material FAI AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
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
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

Similar threads

Top Bottom