OEM IVD's and CE requirements

Q

QA-Man

#11
IVDs are controlled by the IVD Directive, not the MDD.
I thought an IVD was an inta vas device (the male version of an IUD) not an in vitro diagnostic device (which I thought was IVDD). That's why I brought up the MDD rules on implantable devices and contraception.

Classifications are completely different when it comes to in vitro diagnostic devices. They have a List A & List B system. So please disregard my posts regarding the class of the device in question.
 
Elsmar Forum Sponsor
B

brandomenon

#12
If we put together the documentation suggested for Notified Body review of an Own Brand Labeled device, should that be enough for a self-declared device?

Since we have a couple of CE marked IVD's already, our procedures are in place for Vigilance and Post Market Surveillance, labeling and display of the CE marking, preparation of Declaration of Conformity, process for identifying significant changes, registration with Competent Authorities, and process for selection and control of the original manufacturer.

I'm also wondering if anyone has any personal experience with OEM with respect to an Authorized Representative? Has anyone experience problems because they have a different AR than the original manufacturer? Any other advice?
 
Z

zhang126

#13
Follow the following steps to CE-mark your OBL IVD;
1. to compile a TF (have an agreement with the supplier to have access to its TF)
2. to comply with ISO 13485 (certified by a NB)
3. to make a DoC
4. to assign a EU rep (if you are outside of EU)
5. to comply with the language requirements of the target markets
6. to let your EU rep notify its national competent authority to place the IVD on the EU markets
7. to launch your IVD.

You are done!
 
M

MedQE

#14
My company is looking to add to our product line by entering an agreement with a company to re-label their existing CE marked IVD with our branding. Both devices would then be available in the marketplace. We currently have a couple of self-declared CE marked IVD products (Class II).

How do we make sure all our regulatory bases are covered (i.e. what's the path of least resistance to CE marking the device with our labels on it)? The directive is clear that we are still the 'manufacturer' but does not provide much guidance on technical files or dealing with NB's.

Thanks!
The manufacturer places the CE Mark, that would be them not you. If you rebrand it sell it as yours you are also responsible from a legal perspective so verify their technical file or documentation supports placement of the CE Mark per the IVD Directive Essential Requirements (EMC testing has been done to IEC 61326, safety testing completed to IEC 61010-1, risk analysis per 14971, etc). It can be self-certified if its not considered a high risk device per the IVDD.
If their documentation is not up to snuff to support CE Marking then do these things yourself.
 
R

Roland Cooke

#15
The manufacturer places the CE Mark, that would be them not you. If you rebrand it sell it as yours you are also responsible from a legal perspective so verify their technical file or documentation supports placement of the CE Mark per the IVD Directive Essential Requirements (EMC testing has been done to IEC 61326, safety testing completed to IEC 61010-1, risk analysis per 14971, etc). It can be self-certified if its not considered a high risk device per the IVDD.
If their documentation is not up to snuff to support CE Marking then do these things yourself.


Just be a little careful here. From a regulatory perspective, the manufacturer is whoever puts their name on the box. If the product is offered under two different company names, then there are two legal manufacturers. If the product is offered under two different product brand names, but there is a single identified manufacturer, then there is only company that needs to apply the requirements of the MDD/IVDD.


This is also why you need to be very careful with descriptors like:

"manufactured for"
"manufactured by"
etc

The way the UK MHRA has always (semi-officially) interpreted this is basically "whoever's name is biggest on the box, if not otherwise completely unambiguous".

"Distributed by" is usually okay, but then the legal manufacturer must also be clearly identified of course, I would recommend with the legal manufacturer symbol (from EN980) clearly associated with the name.
 
T

Thukira

#16
Hi can you please help me in detail the ways to handle if there are two legal entity of class II product

what would be case:
1) manufactured by
2) manufactured for


Because we fit into the category of "manufactured for"

Please help..
 
R

Roland Cooke

#17
This applies to the EU only

Own Brand Labelling went away as an option in September 2017. The legal manufacturer now has 100% requirement to retain and manage all documentation (etc), even if they are a virtual manufacturer.

"Manufactured By" and "Manufactured For" were never legally recognised under the MDD. I think these exist to some degree under the FDA QSR.

You say you "manufacture for". That doesn't really mean anything under the EU MDD since there can only be one legal manufacturer, and that legal manufacturer must have its own EU Rep if the LM is outside the EU.

You are either
i) a subcontractor to the legal manufacturer (your customer), or
ii) you are the legal manufacturer, and your customer is formally distributing your product.

There isn't a third option.


Things get a little murkier, since you could potentially have a big "marketer name" and a small "legal manufacturer" name (next to the EN ISO 15223 symbol for legal manufacturer).
But that's probably a little risky, since as I mentioned upthread, the MHRA really doesn't like that, and that's a view that's probably shared by the other Competent Authorities.
 
Thread starter Similar threads Forum Replies Date
N OBL under the MDR. Which are the obligations of the OEM? EU Medical Device Regulations 0
S OEM full range calibrations vs Validation special test points Medical Device and FDA Regulations and Standards News 0
S CE marking for OEM Brand CE Marking (Conformité Européene) / CB Scheme 10
A OEM On-Site Calibration issues during Covid19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
K New supplier audit as per V3.1 by French Automotive OEM General Auditing Discussions 2
V UDI - OEM or OBL / Legal Manufacturer Responsibility CE Marking (Conformité Européene) / CB Scheme 0
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
K OEM specific requirements - PPAP was rejected by STA Customer and Company Specific Requirements 5
M OEM asking for NC report after certification audit. IATF 16949 - Automotive Quality Systems Standard 3
V Informational SMMT IATF Oversight - OEM KPI Process IATF 16949 - Automotive Quality Systems Standard 4
J Which OEM or customers are now requiring the new AIAG/VDA FMEA format? FMEA and Control Plans 2
V OEM / PLM Japan Japan Medical Device Regulations 1
A Calibration required by OEM General Measurement Device and Calibration Topics 2
C External Laboratories and OEM Calibration IATF 16949 - Automotive Quality Systems Standard 0
B Need For BIS Standard Mark? Imported OEM's Power supply,Li-Ion Battery Other Medical Device Regulations World-Wide 0
A OEM branding - My interpretation of the LVD Directive makes us a manufacturer CE Marking (Conformité Européene) / CB Scheme 3
DuncanGibbons OEM specifications such as AIPS spec from Airbus AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
A Certification procedure for OEM/PLM collaboration in the medical device industry in the US - Who bears the regulatory responsability? Other US Medical Device Regulations 10
P Sterilization Subcontractor of OEM ISO 13485:2016 - Medical Device Quality Management Systems 6
C Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
R Contract Manufacturer/OEM Supplier - We are a specification developer for a kitted product 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B MDSAP for OEM products in Canada for in vitro diagnostic test kit to include lancing device Other Medical Device Related Standards 0
S Beginner trying to OEM a medical device - Branded Electric Acupuncture Pen EU Medical Device Regulations 3
H Can an OEM use an CM ISO 13485 certification in helping to get out CE Mark? ISO 13485:2016 - Medical Device Quality Management Systems 2
supadrai Just found out the hard way that only one registration per manufacturer is allowed in Yemen, regardless of OEM or private label arrangement. Other Medical Device Regulations World-Wide 0
S Is Certificate of Conformance required for an OEM released product? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
N Regulatory Responsibilities of an OEM and Private Label manufacturer Canada Medical Device Regulations 3
supadrai OEM Changing the name of the manufacturer - length of process? Is 1-3 months correct? Other Medical Device Regulations World-Wide 0
S OEM and PLM under MDR EU Medical Device Regulations 2
P Responsibility for Design Transfer - OEM vs. CM ISO 13485:2016 - Medical Device Quality Management Systems 6
supadrai Indonesian MOH Regulation Restricting OEM/Private Label Medical Devices Other Medical Device Regulations World-Wide 2
C How long is an OEM obligated to provide spare parts and repair EU Medical Device Regulations 2
S Virtual manufacturers/OEM - CE/ISO requirements EU Medical Device Regulations 7
C Relabeling Product Manufactured by the OEM 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
S IMDS helper app or program or paid service at OEM? RoHS, REACH, ELV, IMDS and Restricted Substances 0
M Piggy Backing on OEM's CE certificate EU Medical Device Regulations 1
J CQI-9 - Can OEM do Oven Studies? Reliability Analysis - Predictions, Testing and Standards 1
M OEM-OBL ISO 13485 Certification - Devices mentioned in the product scope ISO 13485:2016 - Medical Device Quality Management Systems 4
M OEM vs OBL Classification in the CE Certification EU Medical Device Regulations 5
K Does OEM/OBL-Relationship need to involve an EU Authorized Representative? EU Medical Device Regulations 11
D Does AS9100 certified OEM need AS9110 if no maintenance is provided? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
3 Brasil: OEM Medical Device Business - Product Design Customization Other Medical Device Regulations World-Wide 6
R Is PFMEA (Process FMEA) for OEM sufficient to address Risk? ISO 13485:2016 - Medical Device Quality Management Systems 7
V Production Documents for Electrical/Electronic OEM Manufacturing and Related Processes 6
P Medical Device OEM, OBL and Private Labeling Questions EU Medical Device Regulations 5
R TS16949 requirements for Motorcycle OEM Parts Suppliers (Batteries) IATF 16949 - Automotive Quality Systems Standard 1
O Certification of OEM Medical Devices EU Medical Device Regulations 12
L Continental Automotive (or any other big German OEM) APQP list wanted VDA Standards - Germany's Automotive Standards 5
C Termination of Technical Agreements with OEM (OBL) ISO 13485:2016 - Medical Device Quality Management Systems 1

Similar threads

Top Bottom