Plea for advice on transitioning between Notified Bodies (label updates)

R

RAMedOrtho

#1
Evening all,

First time posting so apologies if I have done anything incorrectly!

My company has recently transferred to a new Notified Body due to previous NB suspending the CE marking aspect of their business. When we transitioned the new Notified Body (UK) assured us we could then swiftly transition to their EU NB, we were given an expected date of 29 March 2020 for completed EU transfer, only a few weeks after the UK NB certs were issued to us. They have now told us that our transition to the EU NB will not be until 24 April 2020.

This is causing us some worry as we had hoped to only update labelling once (straight to EU NB based on their assurance that it was extremely quick process to move from UK to EU). We received our UK NB certificates end Feb (ISO 13485:2016, Annex V) and beginning of March (Annex II). Due to stocking we determined our labels needed to be updated by June/Jul at the latest to ensure minimal stock write off at the end of the 6 month period. As they have delayed us this shortens our labelling implementation window by just over a month. The alternative is we manage a labelling update to their UK number and then again to the EU number, however, we have approx 220 pieces of artwork which will need updating. This could also impact on our stock as we will need to make sure nothing is placed on the market past the deadline(s). We are also concerned the EU NB transfer could be delayed again leaving us in a very precarious situation.

Has anyone else experienced this? The UK NB have told us that we can ask for an extension to the usual 6 month update timeline but we need to provide a rationale which their global team would then have to review and approve. Does anyone have any advice for doing this? We understand that this is a difficult time for everyone and are trying not to react hastily, any help would be greatly appreciated.

Thank you.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
I think that in the current situation any action plan based on things that are "supposed to happen by X" is too risky. Such promises are nothing more than wishful thinking right now. I think you should develop an robust action plan based on what you ALREADY HAVE at hand, even if that means more work / less efficiency / some loss (which everyone will experience anyway in the coming months). Be realistic.
 
Thread starter Similar threads Forum Replies Date
J Advice on documentation for project I am working on... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
A Need career advice on QMS & HSE (No hands on experience) Career and Occupation Discussions 6
D Question and advice for a supplier self audit questionnaire ISO 13485:2016 - Medical Device Quality Management Systems 6
F Need Quality Manager advice. Quality Manager and Management Related Issues 6
W 17025 and NIST handbook relationship (need advice) ISO 17025 related Discussions 8
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Advice on how to reduce overhead of handling non-conforming material Nonconformance and Corrective Action 7
K Interesting Discussion "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
P IDEs and Clinical Investigators - Advice About Records? Other US Medical Device Regulations 3
M Experience and advice with certifications categories Training - Internal, External, Online and Distance Learning 3
S Need advice for schooling Quality Manager and Management Related Issues 5
M Advice needed for SEH Compliance Software and ISNETWord Compatabiliy Occupational Health & Safety Management Standards 2
R Advice needed: Shall I report my not complying company to NB / competent Authority (Europe) EU Medical Device Regulations 6
D Advice on capturing electronic signatures ISO 13485:2016 - Medical Device Quality Management Systems 8
E 13485:2016, Sections 4.1.6, 7.5.6 and 7.6 - Validation of Software - Need some Advice please ISO 13485:2016 - Medical Device Quality Management Systems 3
M Clinical Development Plan - Advice Requested EU Medical Device Regulations 11
S HIPAA-compliant monitoring software (advice needed) Hospitals, Clinics & other Health Care Providers 1
N Looking to Impress - New Job - Advice, Thoughts, Comments Welcome Career and Occupation Discussions 23
J Masters Degree - Advice about a decision I"m going to be making Career and Occupation Discussions 9
S California Cleaning Product Right to Know Act - Product Label advice needed Miscellaneous Environmental Standards and EMS Related Discussions 1
M Seeking advice regarding use of off-the-shelf (OTS) batteries Other Medical Device and Orthopedic Related Topics 4
S Selling Clinical Practice Advice Other US Medical Device Regulations 7
T Advice needed - Environmental MS - unwritten but customer requests policy document ISO 14001:2015 Specific Discussions 5
M Process Creation Advice Needed Design and Development of Products and Processes 3
classical_quality AS9100 Surveillance Audit - advice on drafting strong responses AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
A Single use non-sterile syringe used in the oral cavity - Laboratory test advice US Food and Drug Administration (FDA) 7
O ISO 9001 new certification advice request - Develop a QMS from scratch ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D ISO 9001:2015 Internal Audit Training Advice Internal Auditing 10
kmrcial Any advice for a young quality professional in the aerospace industry? Career and Occupation Discussions 10
R Pls help --- Need expert advice on Video Measurement Measurement Uncertainty (MU) 0
C Advice on becoming a AS9100 Auditor - Need to audit organizations that are Design Responsible AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
R Customer supplied material - risk and policy advice needed Quality Manager and Management Related Issues 11
D FDA Pre-Submission Meeting Advice US Food and Drug Administration (FDA) 0
qualprod Effective Auditing advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
T Unique Device Identifier Advice Other US Medical Device Regulations 1
M Medical Device News Health Canada Update - 05-09-18 - Pilot Device Advice Canada Medical Device Regulations 0
D AS9100 Document Management (Advice Needed) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
T Establishing -F- datum - need advice Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
C First Aid Kit Compliance advice - Registered assembler with the MHRA EU Medical Device Regulations 1
A Looking to certify to ISO 9001 - Any advice? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Q Advice on selecting an ISO 9001:2015 Lead Auditor Certification Course ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
H Looking for advice, input, tips on taking the AATT AS9101F Test AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
S Nadcap HT Auditor Advisory 17-003 Advice needed AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
J New position and AS9100 audit is 1 month away- need advice AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
P Single Use Disposable Dental Syringe - CE Marking Advice EU Medical Device Regulations 4
Z ISO 9001:2015 Internal Audit Template/Form Advice Document Control Systems, Procedures, Forms and Templates 4
V Looking for advice on Pooled Standard Deviation between Minitab and MS Excel Statistical Analysis Tools, Techniques and SPC 1
rob73 Advice/recommendations for equipment to measure a soft pvc tube - Optical Measuring? General Measurement Device and Calibration Topics 4
S Suggestions or advice on complying with ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
5 Advice for a new EMS at a small, office-based company ISO 14001:2015 Specific Discussions 3

Similar threads

Top Bottom