Manufacturer's responsibility to notify the NB regarding Medical Device End-of-Life

E

eyalhend

#1
Hello all,
My company decided that a certain product (CE marked) will reach to its end-of-life.
In this essence, it would not be manufactured nor distributed anymore.

My question is with regards to the manufacturer's responsibility to notify the NB regarding the above:
1) In case company decides to keep the product registered under its CE certificate (it includes additional products having same technology)
2) In case company decides to exclude this specific product form the CE certificate

Great thanks in advance,
Eyal
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Moderator
#2
Re: Manufacturer's responsibility to notify the NB regarding Medical Device End-of-Li

Hi Eyal,

No strict regulatory obligation comes to my mind, though your contract with your specific NB might say otherwise. I would mention it to your NB auditor on your next surveillance audit, especially if you want that device off your EC certificate.

Cheers,
Ronen.
 
Thread starter Similar threads Forum Replies Date
V UDI - OEM or OBL / Legal Manufacturer Responsibility CE Marking (Conformité Européene) / CB Scheme 0
W Shared Responsibility Between Spec Provider and Contract Manufacturer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
E Manufacturer Responsibility (vs. User/Customer) for Preventive Maintenance/Repair 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
Rameshwar25 Who has Design Responsibility in this Scenario - Rubber Parts Manufacturer IATF 16949 - Automotive Quality Systems Standard 23
M Contract Manufacturer - Technical/Device Master File Responsibility ISO 13485:2016 - Medical Device Quality Management Systems 10
G Labeling Responsibility - Manufacturer vs. Repacker? Proper Component Use ISO 13485:2016 - Medical Device Quality Management Systems 7
R Car (Corrective Action Request) Responsibility - Manufacturer Per Avl Or Supplier Supplier Quality Assurance and other Supplier Issues 3
D Can a contract manufacturer own the technical file EU Medical Device Regulations 1
V Going out of business - related obligation to transferring to another manufacturer EU Medical Device Regulations 0
H SCAR to Vendor or Manufacturer? Supplier Quality Assurance and other Supplier Issues 6
M UL recognized Wire, but no Dielectric breakdown Specified By Manufacturer IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
JoCam Change of Legal Manufacturer EU Medical Device Regulations 2
C ISO13485 scope as Legal Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 2
S OEM- Virtual Manufacturer contract MDR Quality Management System (QMS) Manuals 0
H Registration for REACH required for Non-EU Down Stream Manufacturer? REACH and RoHS Conversations 3
S FDA Contract Manufacturer and Applicant US Food and Drug Administration (FDA) 0
T Manufacturer vs. Specification Developer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B From OBL to Manufacturer EU Medical Device Regulations 4
A Product Liability Insurance coverage for EU Importer by UK Manufacturer EU Medical Device Regulations 3
E Theoretical project: Implementing ISO 13485:2016 into a start up acrylic bone cement manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
A Scope of ISO 13485 certification as legal manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
D What distributor requirement should we (manufacturer) require from the Distributor? EU Medical Device Regulations 0
J Enough for PSUR to cover product family? (Procedure packs, not the legal manufacturer) EU Medical Device Regulations 1
T Does marketing company require CE mark if manufacturer has CE mark on product? EU Medical Device Regulations 5
Melissa Contract Mfg--to Manufacturer with the FDA ISO 13485:2016 - Medical Device Quality Management Systems 4
K 510(k) Manufacturer question (private label and manufacture under another persons 510(k)) US Food and Drug Administration (FDA) 1
S Looking to find a pharmaceutical manufacturer that would be interested in buying or licensing a USDA 510k clearance General Information Resources 4
M FDA Medical device reporting (Manufacturer in US; contract manufacturer OuS) US Food and Drug Administration (FDA) 0
S Country of Manufacturer Medical Device and FDA Regulations and Standards News 0
I Foreign manufacturer registered place of business in EU for CE certification EU Medical Device Regulations 1
G SRN, Basic UDI, Legal Manufacturer EU Medical Device Regulations 6
I Is SRN required for a contract manufacturer (CE-Marking product)? EU Medical Device Regulations 2
H Contract Manufacturer as Design Owner ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
O PPAP'ed part manufacturer has discontinued production Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 7
MedicalDevicesCanada How to find a medical device contract manufacturer, MDSAP certified? Canada Medical Device Regulations 6
M Is there a way to obtain redacted copies of IFU from a different manufacturer? EU Medical Device Regulations 2
D Manufacturer - Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 1
V Delimitation of responsibilities manufacturer-importer EU Medical Device Regulations 2
V Delimitation of responsibilities manufacturer-importer CE Marking (Conformité Européene) / CB Scheme 0
shimonv Working with a contract manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 3
S Legal Manufacturer EU Medical Device Regulations 2
S Who is technically and legally a "Contract Manufacturer"? ISO 13485:2016 - Medical Device Quality Management Systems 4
E Component manufacturer or contract manufacturer ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
G Competent Authority non-EU Manufacturer EU Medical Device Regulations 7
I Foreign manufacturer: how to conduct Clinical Investigation? EU Medical Device Regulations 7
J The necessity and benefit of ISO13485:2016 for a manufacturer of class I devices ISO 13485:2016 - Medical Device Quality Management Systems 3
T CE Marking - Bench mark Device from same manufacturer CE Marking (Conformité Européene) / CB Scheme 2
S For Parts Manufacturer Approval (PMA) Is 100% Inspection Required? Federal Aviation Administration (FAA) Standards and Requirements 2
M Brand owner or manufacturer responsible for Basic UDI-DI and UDI-DI? EU Medical Device Regulations 8
J EC Certification transfer from CMO to Legal Manufacturer Possible? CE Marking (Conformité Européene) / CB Scheme 0

Similar threads

Top Bottom