Impact of Distribution Center Site Change on Product Registrations

W

William_55401

#1
Question. We are a medical device mfr planning a change in EU distribution sites. There is no planned change to the manufacturing site. Does anyone have insight as to the impact of this change on Technical Files or rest of the world product registrations? My first reaction is to say no impact as distribution does not typically show up in Tech Files, EU labeling, or in product registration documents. Please share your thoughts. Thank you for your help.
 
Elsmar Forum Sponsor
M

MIREGMGR

#3
I assume your Forum-location is the responsible manufacturer's location, i.e. USA?

If so, then EU device registration is handled by your Authorized Representative, and you can leave to their expertise whether the change you want to make has any significance.

My guess is that it won't, i.e. I agree with your analysis in full, but they can make the call based on more complete knowledge of the details.
 
W

William_55401

#4
Thank you MRI. This is very helpful. I have been reading your posts and was hoping you would check in on this one.
 
Thread starter Similar threads Forum Replies Date
F Moving our Distribution Company - ISO 9001 Certification Impact ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R Impact of changing manufacturer post clinical investigation CE Marking (Conformité Européene) / CB Scheme 3
Ed Panek Corona Virus impact on Supplier Audits and Received Parts ISO 13485:2016 - Medical Device Quality Management Systems 4
F Will the EU postpone 2017/745 MDR Implementation - COVID-19 Impact Medical Device and FDA Regulations and Standards News 11
R Revalidation machine line and Stability Studies impact. Medical Device and FDA Regulations and Standards News 3
M MDR Impact on MDSAP Countries Other Medical Device Regulations World-Wide 16
Watchcat Impact of MDR on Availability of Medical Devices in EU EU Medical Device Regulations 5
Judy Abbott Can any one help me with an urgent BIOCOMPATIBILITY Impact assessment? Internal Auditing 9
G Is impact test according to IEC 60601-1 applicable for HAND-HELD equipment if also classified as BODY-WORN? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A IEC 60601-1 Impact test on glass touch controller IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
Q The Perfect audit? External Audit causes a significant negative impact in a company General Auditing Discussions 9
Ashok sunder Is it possible to reduce Risk likelihood and impact Post control Ranking after corrective action taken for risk? FMEA and Control Plans 1
E MDR Article 117 / Impact to New Marketing Authorization Applications Other Medical Device Regulations World-Wide 1
C Lithium battery powered Medical Device - 15.3.3 Impact test, broken enclosure IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
R Impact of an MDSAP certificate with all countries coverage Other Medical Device Regulations World-Wide 8
Edward Reesor Canadian News article on impact of MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 10
Q Propose Aspects to evaluate risk impact? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Risk impact can be modified? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R Brexit - European Commission - The impact of the Brexit per March 29, 2019 EU Medical Device Regulations 3
B The impact of IoT in ISO documentation IT (Information Technology) Service Management 1
J Business Impact Analysis SOP Business Continuity & Resiliency Planning (BCRP) 2
T GDPR impact on ISO 9001 and Quality ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Raffy What is the first step in doing PIA (Privacy Impact Assessment)? IEC 27001 - Information Security Management Systems (ISMS) 3
Sidney Vianna IATF 16949 Areas of Impact - Rules 5th Edition Document (February 2017) IATF 16949 - Automotive Quality Systems Standard 0
I Biocompatibility Impact on Autoclaved Silicone Other Medical Device Related Standards 3
R Tensile Test Strain Rate - Impact on the Test Results Manufacturing and Related Processes 3
K Thoughts on the impact of the General Data Protection Regulation? Medical Information Technology, Medical Software and Health Informatics 5
Q Risk Impact - Risk Assessment Sample/Method per ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Difference between Environmental Impact and Risk ISO 14001:2015 Specific Discussions 7
M 15.3.3 Ball Impact Test requirements in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Calculating impact force, expressed in lbs, of a 5 lb weight dropped 48 inches Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
J Charpy impact test - Mill cert for API 13CrL80 coupling stock material with is PLS 2 Oil and Gas Industry Standards and Regulations 1
K TS 16949 Planning Phase: Raw Materials purchased from Distributer and the PPAP impact IATF 16949 - Automotive Quality Systems Standard 3
A Product Impact When Thread Rings Require Adjustment General Measurement Device and Calibration Topics 9
Marc What companies think climate change will have a material impact on their business? Sustainability, Green Initiatives and Ecology 11
K IEC 60601-1:2012 - Impact Assessment for changes from IEC 60601-1:2005 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K Business Impact Analysis Questionnaire - Financial Implications Business Continuity & Resiliency Planning (BCRP) 1
Howard Atkins Rules 4th Edition Areas of Impact for Client Consideration IATF 16949 - Automotive Quality Systems Standard 1
S Exploring the Impact of Changes in ISO 14001:2015 ISO 14001:2015 Specific Discussions 3
Q Complete Company Restructuring & Impact on ISO 9001 Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Do Volume Spikes impact Quality Scores and Utilization? Which Tool To Use Statistical Analysis Tools, Techniques and SPC 2
A Organization Name Change & Its Impact in QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Medical Device Software Version Upgrade Regulation Impact 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
AnaMariaVR2 Legal Flash: 8 Regulations set to impact the Pharma & Biotech Industry in 2013 US Food and Drug Administration (FDA) 0
G TS-16949 7.6.2 ? Calibration/Verification Records - Assessment of the Impact IATF 16949 - Automotive Quality Systems Standard 5
J IEC 60601 (Steel Ball Impact Test) Other ISO and International Standards and European Regulations 1
G Combining Aspect Impact and Hazard Risk Register Miscellaneous Environmental Standards and EMS Related Discussions 8
jasonb067 Scope / Certification Impact Two companies, One roof IATF 16949 - Automotive Quality Systems Standard 4
D What the impact is of a high %GRR/TV Capability, Accuracy and Stability - Processes, Machines, etc. 6
S Using ANSI/ASQ Z1.4 to Reduce Impact of Field Service Campaign AQL - Acceptable Quality Level 17
Similar threads


















































Top Bottom