Office and manufacturing site relocation effect on Device Technical File

MedicalResp

Starting to get Involved
#1
Hi all,
Hoping to pick your brains (and experience) :

Our company has CE marking under MDD (class IIb) that is valid until 2024.
We relocated our office and manufacturing site to another location within the same city.
We are preforming a complete process validation (IQ,OQ,PQ) in the new facility.
We have already notified our Notified Body and they requested:
1) A review of the Technical File.
2) Phase 1 (Documentation review Address Change : QMS + TF): Off-site Evaluation of Quality System Documents, Procedures and their application in reference to the Medical Device (s) object of the CE Certification
3) Onsite audit at the next surveillance audit.

I understand the NB requirement to review the QMS changes, the new process validation reports and the IFU and labels, but I do not understand their requirement to fully review again the Technical File.
Is this legtimate requirement? Also, in that case, must we update the new address in design validation reports and certificates preformed 2 years ago by external labs (e.g. IEC/EN 60601-X) ?

On a similar topic:
my understanding is that an address change is considered an administrative and "not-significant change" under the MDR (MDCG 2020-03) and that a CE certificate under MDD shall remain valid if the change is not significant. So hypothetically, if we relocate again to a new facility after May 26, 2021 , could the NB review again the the QMS and technical file and issue us a revised CE certificate with the new address or would there a clash with MDR Article 120 ?

Thanks in advance
 
Elsmar Forum Sponsor
#2
Hi all,
Hoping to pick your brains (and experience) :

Our company has CE marking under MDD (class IIb) that is valid until 2024.
We relocated our office and manufacturing site to another location within the same city.
We are preforming a complete process validation (IQ,OQ,PQ) in the new facility.
We have already notified our Notified Body and they requested:
1) A review of the Technical File.
2) Phase 1 (Documentation review Address Change : QMS + TF): Off-site Evaluation of Quality System Documents, Procedures and their application in reference to the Medical Device (s) object of the CE Certification
3) Onsite audit at the next surveillance audit.

I understand the NB requirement to review the QMS changes, the new process validation reports and the IFU and labels, but I do not understand their requirement to fully review again the Technical File.
Is this legtimate requirement? Also, in that case, must we update the new address in design validation reports and certificates preformed 2 years ago by external labs (e.g. IEC/EN 60601-X) ?

On a similar topic:
my understanding is that an address change is considered an administrative and "not-significant change" under the MDR (MDCG 2020-03) and that a CE certificate under MDD shall remain valid if the change is not significant. So hypothetically, if we relocate again to a new facility after May 26, 2021 , could the NB review again the the QMS and technical file and issue us a revised CE certificate with the new address or would there a clash with MDR Article 120 ?

Thanks in advance
Yes it will need to be reviewed to ensure all the labelling and any QMS documentation has been updated to reflect the new address
 

MedicalResp

Starting to get Involved
#3
Yes it will need to be reviewed to ensure all the labelling and any QMS documentation has been updated to reflect the new address
As I wrote, I understand the need to review lables and IFU, but why to review all the TF ? Also, I am not sure if in this case, we must update the new address in design validation reports and certificates preformed 2 years ago by external labs (e.g. IEC/EN 60601-X) .
 
Thread starter Similar threads Forum Replies Date
G Microsoft Office 365 Business plan questions Business Continuity & Resiliency Planning (BCRP) 10
E Consultant with Office 365 experience Consultants and Consulting 2
B Can we be ISO 9001 certified without a physical office? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Watchcat Office of In Vitro Diagnostic and Radiological Health (OIR) De novos 2018 Other US Medical Device Regulations 1
S Tracking laptop movement inside the office IEC 27001 - Information Security Management Systems (ISMS) 7
tony s An organization's Internal Audit Office certified to ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
M Remote Office only has Invoice Function - Audit Needed? IATF 16949 - Automotive Quality Systems Standard 0
T SPC in Insurance Back Office Operations Service Industry Specific Topics 4
L Computer stations unlocked - Office Stations vs Production Stations Supply Chain Security Management Systems 4
5 Advice for a new EMS at a small, office-based company ISO 14001:2015 Specific Discussions 3
B Taiwan Medical Device registration - Production or legal office Other Medical Device Regulations World-Wide 6
R ISO 14001 Environmental targets - Office only ISO 14001:2015 Specific Discussions 9
S Re-validation - MS Office Upgrade Quality Assurance and Compliance Software Tools and Solutions 3
A Office that only manages Contracts - Exclusion of Clause 7.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T Kids in the office from an auditors standpoint ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
S ISO9001:2008 for Sales Office ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Technical Oversight - Government Shipyard Quality Office Responsibilities Quality Manager and Management Related Issues 10
L Certification for new company global engineering office ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B EMP (Environmental Management Program) for an Office Miscellaneous Environmental Standards and EMS Related Discussions 8
AnaMariaVR2 3 Ways To Deal With People Who Play Office Politics Against You Coffee Break and Water Cooler Discussions 7
D Requirements & Responsibility regarding Fire Foam in an Office Miscellaneous Environmental Standards and EMS Related Discussions 5
P Certification of an office in different country ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
K AS9101D - PEARs only at Head Office AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Richard Regalado BYOD (Bring Your Own Device) Policy by UK Information Commissioner's Office IEC 27001 - Information Security Management Systems (ISMS) 0
V Alternative to Microsoft Office - Open Office vs. Google Docs After Work and Weekend Discussion Topics 26
I Environmental - Office Recycling and Waste Management Programme and Objectives Quality Manager and Management Related Issues 2
G 10 Things You Should Never Say at the Office Coffee Break and Water Cooler Discussions 7
V Query on TS 16949:2009 Certification for a Tool and Die Sales & Service office IATF 16949 - Automotive Quality Systems Standard 3
P Registrar Auditor's Candid Remarks - Should I report him to his office? Quality Manager and Management Related Issues 9
L ISO Certification is only for the Head office but used by all sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
L How to kick off the office Quality Improvement Program (QIP)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P Risk Rating approaches (OHSAS 18001 - For Office Environments) Occupational Health & Safety Management Standards 6
J Backsliding QMS - My office has gone through major management change ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A Documenting 5S Guidelines in the Sales Department (Office 5S) Quality Tools, Improvement and Analysis 4
P Legal Identity - Head Office and Laboratory have different Addresses General Measurement Device and Calibration Topics 1
J MS Office 2010 - Control of Records - ISO 9001 Clause 4.2.3 c Requirements Document Control Systems, Procedures, Forms and Templates 2
T Eliminating "Hard Copy" Manuals from our Office and Shop Floor - Documentation Medium ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D Office Supplies and Furniture needs Ordering Process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
N Asked to create a baseline survey on emails that come in and out of our Office Document Control Systems, Procedures, Forms and Templates 1
Q Best tools to use to determine the best layout of a given area (Office) Process Maps, Process Mapping and Turtle Diagrams 9
AnaMariaVR2 Office Prank - Making an Office Disappear Funny Stuff - Jokes and Humour 0
J Auditing the Project Management Office ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T Office Relocation Installation Inspection Sheet Document Control Systems, Procedures, Forms and Templates 5
M How to make an X Median symbol (capital X with a tilde on top) in MS Office Quality Assurance and Compliance Software Tools and Solutions 11
F Adding a New Office Location to an ISO 9001 Certificate (Scope of Registration) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q Office, Pdf, Special Forms for Procedures? Economical Documentation Document Control Systems, Procedures, Forms and Templates 11
A Workforce Planning for Back office Management Review Meetings and related Processes 2
A New Office Imported Legacy Blogs 6
C Bringing a Second Office Location into Registration Scope ISO 14001:2015 Specific Discussions 12
D Using UK system for certification for a USA office? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3

Similar threads

Top Bottom