Is SRN required for a contract manufacturer (CE-Marking product)?

#1
Hi all,

Our company is a contract manufacturer of a CE-Marking product. It's been noticed for a while that MDR requires all legal manufacturers to have their SRN. I used to believe, as a contract manufacturer, we don't need to register ourselves on EUDAMED. However, from a recent symposium, I heard a NB said the contract manufacturer needs to fulfill all the necessary requirements of a MFR listed in MDR including obtaining an SRN. I was wondering if it is an interpretation made by the specific NB or it's me who actually misinterpreted the definition of a MFR in MDR? We're not a legal MFR thus won't apply for product registration under MDR. Thus, there's no appropriate channels for me to ask around. Please kindly share your thoughts and experiences to communicate with your NB. Thanks.
 
Elsmar Forum Sponsor

ParisTommy

Starting to get Involved
#2
Hello,

The Legal Manufacturer needs to get a SRN and register on EUDAMED.

The Legal Manufacturer will have to give your details to their NB, and you may have an (unannounced) audit from the NB, but I have never heard of a requirement for subcontractors to register on EUDAMED.

Surely if you are purely a subcontractor (and don't put devices on the market under your own name), you are not an economic operator under the sense of the MDR, so therefore, do not need to register.

I'd be interested to see if other people have heard this too...

Kind regards,
Tom
 
#3
Hello,

The Legal Manufacturer needs to get a SRN and register on EUDAMED.

The Legal Manufacturer will have to give your details to their NB, and you may have an (unannounced) audit from the NB, but I have never heard of a requirement for subcontractors to register on EUDAMED.

Surely if you are purely a subcontractor (and don't put devices on the market under your own name), you are not an economic operator under the sense of the MDR, so therefore, do not need to register.

I'd be interested to see if other people have heard this too...

Kind regards,
Tom
Hello Tommy, do you know if we change the legal manufacture address from A(America) to B(Europe), but same brand, same company, same product, same OEM(From Asia), do we need to obtain a new manufacturer SRN and a new basic UDI?
 
Thread starter Similar threads Forum Replies Date
renenatasha Single Registration Number (SRN) EU Medical Device Regulations 2
G SRN, Basic UDI, Legal Manufacturer EU Medical Device Regulations 6
D How to get EUDAMED Single Registration Number (SRN) EU Medical Device Regulations 19
B AS9100:D - Purchase Order required if ordering paint on supplier portal? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
V Is it required to recalibrate reference- standard instruments after equipment qualification General Measurement Device and Calibration Topics 0
B Supplier Evaluation report - Validation required or not ISO 13485:2016 - Medical Device Quality Management Systems 2
H Registration for REACH required for Non-EU Down Stream Manufacturer? REACH and RoHS Conversations 2
P AS9100D clause 8.6 - Documentation required to show evidence of conformity AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Is IATF certification required when customer doesn't require it? IATF 16949 - Automotive Quality Systems Standard 19
Kevin Walters IAQG Required Audit Days Needed (Please help) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Is MDSAP Audit Required? ISO 13485:2016 - Medical Device Quality Management Systems 3
H Required explanation of sub clause 7.2.101.2 (Exception) of IEC 61010-2-020:2006 CE Marking (Conformité Européene) / CB Scheme 5
Ashland78 PPAP required for repair of machine? IATF 16949 - Automotive Quality Systems Standard 5
Y Is preventive action required for each CAPA initiated? ISO 13485:2016 - Medical Device Quality Management Systems 24
B Spreadsheet - Used for complaint investigation - Validation required or not ISO 13485:2016 - Medical Device Quality Management Systems 9
N 8.3.3.3 Special characteristics - Auditor said we are required to create our own, if no customer char. exist. IATF 16949 - Automotive Quality Systems Standard 10
P 9.2.2.2 & 9.2.2.3 Audit Cycle alignment required? IATF 16949 - Automotive Quality Systems Standard 1
M Is complete testing required as per ISO 10993 for materials used in orthopedic implants or is literature review route possible Other Medical Device Related Standards 3
I Are suppliers required to hand over process validation reports? ISO 13485:2016 - Medical Device Quality Management Systems 20
B Is 14971 Annex C checklist now in ISO/TR 24971 required to complete prior to 510k filing? ISO 14971 - Medical Device Risk Management 3
D IEC 60601-1-2: Is EMC immunity testing required for a device without essential performance? IEC 60601 - Medical Electrical Equipment Safety Standards Series 25
V ISO 9001 or ISO 17065 required for an organization issuing 5 star rating certification of digital experience? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D Is calibration really required? IATF 16949 - Automotive Quality Systems Standard 6
D Filling totes and pails - when is a calibrated scale / flowmeter required in ISO 9001 General Measurement Device and Calibration Topics 4
S Supplier performance required to be reported to supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S Is the Design Service Provider required to be ISO 13485 certified? ISO 13485:2016 - Medical Device Quality Management Systems 13
B What are "appropriate drawings" required for a MDR in 21CFR820? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Record approval- Signatures required ISO 13485:2016 - Medical Device Quality Management Systems 4
M MDSAP required for Device Initial Importer/Distributor into Canada? Other Medical Device Regulations World-Wide 11
O New GTIN (DI) required? Other US Medical Device Regulations 0
P Is the second factor authentication (2FA) required for external users? Qualification and Validation (including 21 CFR Part 11) 1
validationspec EN 868-5 pdf required. Medical Device and FDA Regulations and Standards News 1
F Uncertainty not Required Measurement Uncertainty (MU) 3
I How to find required testing for a specific device? Other US Medical Device Regulations 3
U Is Initial Importer Status Required if a Medical Device is Manufactured and Sterilized by an OEM in the US Other US Medical Device Regulations 1
S Is it required to complete Internal Audits within one year? ISO 13485:2016 - Medical Device Quality Management Systems 29
D "certified" in ISO 19011, as well as IATF required? IATF 16949 - Automotive Quality Systems Standard 6
M Is validation required when consumables are changed Qualification and Validation (including 21 CFR Part 11) 7
B Is labeling on the device itself required? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
J Scrap Material Scale Calibration Required? IATF 16949 - Automotive Quality Systems Standard 21
K Is Calibration Required for Non-Adjustable Commercial Inspection Devices? General Measurement Device and Calibration Topics 11
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Does a refurbished product required a new UDI? US Food and Drug Administration (FDA) 3
S For Parts Manufacturer Approval (PMA) Is 100% Inspection Required? Federal Aviation Administration (FAA) Standards and Requirements 2
B AS9102 - 3D printing a special tool required for assembly (counterfeit risk?) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
R "Medical devices" required in scope ISO 13485:2016 - Medical Device Quality Management Systems 2
OpExPro AIAG VDA DFMEA Template Required FMEA and Control Plans 6
B PMA Supplement Required? US Food and Drug Administration (FDA) 3
F UDI-PI required on packaging (MDR) EU Medical Device Regulations 4
S Required tests for Surgical gown US Food and Drug Administration (FDA) 1

Similar threads

Top Bottom