Requirement for NB audit with Discontinued Product

C

claireyvb

#1
Morning Covers,

We are a company who Own brand label Class IIa devices. We do this by sending our branding to the OEM who then incorporate into their design and we buy the finished product.

We have a NB audit due in June 2013. If we discontinued stock and allowed to sale through prior to June 2013 (no more stock purchased), in your opinion would a NB audit still be required?

I understand that under the directives (93/42/EEC and 2007/47/EC) we still have a regulatory obligation to continue with PMS, Vigilance reporting and the retention of records/documents and we will continue to do this.

Can anyone shed any light on this issue before we speak to the NB themselves?

Thanks in advance.

Claire

P.S. Have a great festive period everyone!!
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Morning Covers,

We are a company who Own brand label Class IIa devices. We do this by sending our branding to the OEM who then incorporate into their design and we buy the finished product.

We have a NB audit due in June 2013. If we discontinued stock and allowed to sale through prior to June 2013 (no more stock purchased), in your opinion would a NB audit still be required?

I understand that under the directives (93/42/EEC and 2007/47/EC) we still have a regulatory obligation to continue with PMS, Vigilance reporting and the retention of records/documents and we will continue to do this.

Can anyone shed any light on this issue before we speak to the NB themselves?

Thanks in advance.

Claire

P.S. Have a great festive period everyone!!
Hi Claire ...
Much in advance you have to write to your NB and declare to them the last Sl No. / Batch No. and Quantity of the product(s) and the date by which you will cease to be the manufacturer. The NB will take necessary actions to withdraw your CE in time.
Thereafter no CE, no NB, no MDD Audit, but but ... your PMS, Vigilance reporting and the retention of records/documents you will continue till such time your devices have the lifetime from the date of putting into market.
You would have declared these to your NB in the MDD agreement and these are no more under audit purview.
Have a great festive period too ... and again on such matters please also ASK YOUR NB.
 
Last edited:
M

MIREGMGR

#3
We have a NB audit due in June 2013. If we discontinued stock and allowed to sale through prior to June 2013 (no more stock purchased), in your opinion would a NB audit still be required?

I understand that under the directives (93/42/EEC and 2007/47/EC) we still have a regulatory obligation to continue with PMS, Vigilance reporting and the retention of records/documents and we will continue to do this.
I think you've answered your own question. I expect the NB will want to audit those of your operations that affect your continuing responsibilities, through the declared lifetime of the product you've sold.
 
Thread starter Similar threads Forum Replies Date
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
L Stage 2 audit - Requirement for 3 months of records ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Requirement of Pharmacovigilance (Drug Safety) Risk Based Strategic and Tactical Audit Plan General Auditing Discussions 0
XRAY_3121 Design and Development Requirement - MDSAP Audit Finding Other Medical Device Regulations World-Wide 5
Q IATF 16949 Strategy - Audit Team Requirement IATF 16949 - Automotive Quality Systems Standard 4
S ISO 9001 Audit requirement for maintenance department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
O Requirement to audit locations which have been relocated Registrars and Notified Bodies 4
O Audit Result Breakdowns by ISO 9001 Requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Crimpshrine13 ISO/TS 16949 Pre-Audit Requirement IATF 16949 - Automotive Quality Systems Standard 18
P Audit Design Process every Surveillance Audit - AS9104 Requirement? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
M Requirement for an Update Audit if Company Site Changes ISO 13485:2016 - Medical Device Quality Management Systems 8
T AS9104/3 is bringing in a requirement for an AA to qualify as AEA based on Audit Days AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
B Is there an FDA requirement for a Supplier Audit Schedule US Food and Drug Administration (FDA) 22
J EU labeling requirement Notified body audit finding EU Medical Device Regulations 3
M TS 16949 Clause 8.2.2.4 Internal Audit Plans - Requirement Scope? IATF 16949 - Automotive Quality Systems Standard 3
J Verification of AC0056A requirement during AS9120 audit AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
J Audit Days Requirement for AS9100, Rev C Re-Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
A To CAPA or not to CAPA? Requirement to close our Corrective Actions before Audit? Nonconformance and Corrective Action 8
S ISO 9001:2008 Requirement to Audit 'All Shifts' ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
B EU MDD Requirement on impact of Rev STDs and audit non-conformance EU Medical Device Regulations 6
J PRI - NADCAP Certification requirement - AS9100 audit first before NADCAP audit? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
W Requirement to save original, handwritten internal audit notes? US Food and Drug Administration (FDA) 11
L Surveillance Audit - NC for not referencing requirement of Cl 6.4 in audit plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
R Is passing 'Measurement Audit' a requirement for ISO 17025 Acrreditation? ISO 17025 related Discussions 3
V Is there a requirement for Internal Audit Schedule to be Approved? Internal Auditing 11
L Pre-assessment to Final Audit - Is there a 90 day requirement? Miscellaneous Environmental Standards and EMS Related Discussions 26
D What is the TS 16949 Stage 1 Audit Requirement on Internal Audit? Internal Auditing 16
K What is a 'layered audit'? Layered Process Audit (LPA) - A GM requirement? Process Audits and Layered Process Audits 9
Sidney Vianna How to audit this ISO 17025 requirement? ISO 17025 related Discussions 7
T Process Internal Audit - Requirement on Monitoring Objectives & Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Marc ISO 9001 Three Year Recertification Audit Requirement(s) - Complete Reaudit Registrars and Notified Bodies 6
V TS 16949 - Para. 8.2.2.1 QMS Audit - How are you meeting this requirement? General Auditing Discussions 14
S ISO 14001 - Periodic External Audit by Consultant Requirement? ISO 14001:2015 Specific Discussions 99
D Audit - Zero Nonconformance Requirement IATF 16949 - Automotive Quality Systems Standard 8
Marc Audit Observations - Is there a requirement to Respond to Observations? Registrars and Notified Bodies 14
B QS9000's New Dock Audit Requirement QS-9000 - American Automotive Manufacturers Standard 13
R Is a complete Internal Audit prior to registration a direct requirement of QS9000? Internal Auditing 3
D What is the acceptance criteria/requirement for Stability Study? General Measurement Device and Calibration Topics 5
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
L Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
W Pfmea function requirement and failure mode FMEA and Control Plans 6
Y 510k requirement for bringing in gloves Medical Device and FDA Regulations and Standards News 0
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 2
J When PPAPs are not a contractual requirement APQP and PPAP 9
I Overwhelmed with attribute MSA requirement for visual inspection IATF 16949 - Automotive Quality Systems Standard 8
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Clinical Trial Requirement - No equivalent devices in the market CE Marking (Conformité Européene) / CB Scheme 3
J Requirement for Retention of Records of Withdrawn Documents of External Origin Document Control Systems, Procedures, Forms and Templates 3

Similar threads

Top Bottom