Certification of OEM Medical Devices

Olgamargarita

Involved In Discussions
#1
Hello!!
please, help me to understand the following:
how an OEM company is the manufacturer itself in the sense of the directives on media products?
when they obtain a CE mark, they provide the ce mark to PLM??
 
Elsmar Forum Sponsor

Olgamargarita

Involved In Discussions
#3
Thank you very much or your reply.
According to the Directive 93/42/EEC,
Can OEM company obtain a certificate according to the Directive 93/42/EEC, in spite of they only sell the design and manufacturing??
what part of the directive indicate it?:(
 

pkost

Trusted Information Resource
#4
The original manufacturer designs a device, demonstrates it is safe and effective and manufactures a product; they then CE mark it

Another company comes along and decides that they like the product but don't want the hassle of designing the product so they sign an agreement with the original manufacturer saying that the original manufacturer will provide an identical product (except for artwork), will maintain their CE mark, manage the design and PMS and will inform the new company of any changes, additionally the new company agrees to transmit any complaints/PMS data to the original manufacturer.

The new company can now apply their CE mark because they can demonstrate that they are meeting the requirements of the directive; how can they say that it's safe and effective without all the technical file?....because the original product already has a CE mark which indicates it to be safe and effective!

Where does the directive say you can do this: a better question would be where does it say you can't?
 

Olgamargarita

Involved In Discussions
#5
Thank you very much for the clarification :)
Then, I understand the following:
1. if the OEM company has a product with CE marck (for instance CE 130)and PLM company sign agreement for the identical product, PLM now is the legal manufacturing and keep the CE mark from OEM (CE 130), does not it?

Question:

1. how OEM company can obtain certificate of Directive 93/42/EEC, if it only designs and manufactures, OEM company do not labels the product, PLM (private label manufacturing) states the labeling?? please explain me.

2. if OEM company would not have the certificate of 93/42/EEC, PLM company will request this certificate??

3. considering the case that OEM company has own CE mark, when it decides to make some changes in the product, it have to inform to notified body??? the notified body
considering the magnitude of the changes can be considered that the product needs certify again?

4. please tell me what is he meaning of PMS??

Thank you very much in advance
 
#6
1. if the OEM company has a product with CE marck (for instance CE 130)and PLM company sign agreement for the identical product, PLM now is the legal manufacturing and keep the CE mark from OEM (CE 130), does not it?
CE 130. The 130 is the NB number. If you work with the same NB as that of your OEM and get the certificate, you will also use the CE 130. If you choose and work with an other NB, then when you get the certificate, you will use the number of your NB, alongside the CE. The CE mark is not transferable.
1. how OEM company can obtain certificate of Directive 93/42/EEC, if it only designs and manufactures, OEM company do not labels the product, PLM (private label manufacturing) states the labeling?? please explain me.
When the OEM company has the CE, they can label and place the device in the market. It is their business decision not to label if they so decide.
As a PLM, (I will say OBL - Own Brand labeler) when you obtain CE, you can label and place the device in the market.
2. if OEM company would not have the certificate of 93/42/EEC, PLM company will request this certificate??
OBL company exists only when the OEM company have the certificate. If you want to be the OBL company, you have to identify an OEM who has the certificate, or persuade a company to get the certificate.
3. considering the case that OEM company has own CE mark, when it decides to make some changes in the product, it have to inform to notified body??? the notified body considering the magnitude of the changes can be considered that the product needs certify again?
Yes. Rather, the OEM company will be then aware of the process of identifying significant changes and information to NB. It all depends on the type of change.
4. please tell me what is he meaning of PMS??
Post Market Survelliance
 
Last edited:

Olgamargarita

Involved In Discussions
#7
Thank you very much for your reply:)

I have a doubt with the answer 2.

a. It means that for to sign agreement with a OEM company, OEM before have to be certificate 93/42/EEC (the certifcate is on behalf of OEM)???

b. OEM company could meet all requirements of Medical Device Directive but could not get the certificate. it is possible OBL request the certification to notified body, this certificate will indicate as a manufacturer OBl`s name???

Thank you very much,
 

somashekar

Leader
Admin
#8
a. Signing agreement with the OEM is a business process. OBL CE certificate is a regulatory process, for which your OEM must have a CE certificate. As a process for your OBL certification with your NB, this agreement will also form a part of your regulatory documentation that the NB will review.

b. No. The meaning of OBL is that there is some OEM company who have a valid CE certificate and the OBL CE certificate is valid as long as the OEM have the CE certificate. Both will have the same "valid till" date.
By any chance, if the OEM certificate is withdrawn, the OBL certificate becomes invalidated.
 
M

MIREGMGR

#9
There are two relevant guidances on your question.

One is Bulletin 19 from MHRA, the UK Competent Authority.

The other is 3.9 B 16 from ZLG, the German Competent Authority. This second document is only available in German.

I suggest understanding both guidances, because in my reading they do not have equal interpretations. Thus the rules may depend on where you are within the EU, and who is regulating you.
 

Olgamargarita

Involved In Discussions
#10
Thank you very much :)

I have only read the 3.9 B 16 from ZLG, taking into account the information on it, please help me with the following questions:

1. Can OBL company sign an agreement with OEM company without CE certification. Then OBL will request to Notified Body to perform the certification CE??? This CE certification will get to behalf of OBL company???

2. If OEM company have a CE certification, it is neccesary that OBL company request CE certification again??

3. Considering the question 2 is correct, when OEM company do some relevant or non relevant changes on the product, which of the two CE certificates (CE certificate of OEM as issued by Notified Body "A" and CE certificate of OBL as issued by Notified Body "B") is involved??

I would appreciate you if you send me this document: Bulletin 19 from MHRA, the UK Competent Authority.

Thank you very much
 
Thread starter Similar threads Forum Replies Date
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
A Selling products with OEM certification expired EU Medical Device Regulations 0
M OEM asking for NC report after certification audit. IATF 16949 - Automotive Quality Systems Standard 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
M OEM-OBL ISO 13485 Certification - Devices mentioned in the product scope ISO 13485:2016 - Medical Device Quality Management Systems 6
M OEM vs OBL Classification in the CE Certification EU Medical Device Regulations 5
W Can an OEM like Honda, GM, Ford can get TS 16949 certification? IATF 16949 - Automotive Quality Systems Standard 29
Sidney Vianna United Technologies Aerospace OEM Mandating AS9100 Certification by June 30, 2004 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
S Eligibility for certification to IATF16949 IATF 16949 - Automotive Quality Systems Standard 8
M ASQ certification study material Professional Certifications and Degrees 1
A New to QMS and regulatory... advice on training/certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
D Is IATF certification required when customer doesn't require it? IATF 16949 - Automotive Quality Systems Standard 19
A Loss of certification because of outdated information in the Clinical Evaluation Report CE Marking (Conformité Européene) / CB Scheme 8
Sidney Vianna IAQG News Down with OPMT - Long live CERTIFICATION OVERSIGHT AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
H Relation of VDE mark with CE certification CE Marking (Conformité Européene) / CB Scheme 11
T Adding to certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
T Is NRTL certification mandatory in the US ? Registrars and Notified Bodies 1
H EAC-MED Certification CE Marking (Conformité Européene) / CB Scheme 0
Aliken Recommendation for the ISO 13485 certification company ISO 13485:2016 - Medical Device Quality Management Systems 7
A List of documents to prepare for Re-certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
F Attendance possibility for a certification audit ISO 13485:2016 - Medical Device Quality Management Systems 7
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4
K SGS Certification - Advice on their Performance Service Industry Specific Topics 9
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
P How to keep a ISO 9001:2015 certification when a company is sold ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Scope of ISO 13485 certification as legal manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
J CMO in Canada do they need MDSAP/13485 certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO 13485 certification scope ISO 13485:2016 - Medical Device Quality Management Systems 5
A AS9100D new certification cost?? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
N ISCC Plus - The international Sustainability Carbon Certification Sustainability, Green Initiatives and Ecology 2
S Which certification to get? Professional Certifications and Degrees 3
J Implementation, establishment and certification of IATF 16949. IATF 16949 - Automotive Quality Systems Standard 6
D Regulatory Affairs Certification (RAC) Devices Exam - Autumn 2022 study Professional Certifications and Degrees 2
A MDR Article 16 Certification of Distributors by a Notified Body? EU Medical Device Regulations 8
T NDT/NDE Level 2 Technicians Certification Oil and Gas Industry Standards and Regulations 20
M PSE Certification Japan Medical Device Regulations 5
C IATF16949 certification eligibility IATF 16949 - Automotive Quality Systems Standard 6
D IATF 16949 Certification and Letter of Conformance expiry (Help!!!) IATF 16949 - Automotive Quality Systems Standard 8
H API monogram 4F - Certification process Oil and Gas Industry Standards and Regulations 2
J Recommendations for certification bodies ISO 13485:2016 - Medical Device Quality Management Systems 4
S Certification of equipment after move General Measurement Device and Calibration Topics 14
J Help to understand and response to API AAR during the re-certification audit Oil and Gas Industry Standards and Regulations 17
G Medical Device Auditor (CMDA) certification exam by ASQ - looking for input Career and Occupation Discussions 3
D Automotive Customer asking for ISO 14001 Certification from suppliers ISO 14001:2015 Specific Discussions 3
I Foreign manufacturer registered place of business in EU for CE certification EU Medical Device Regulations 1
eldercare Multi-Site ISO/AS Certification Requirement for some sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
Casana ISO 17025 - Contractor certification? IATF 16949 - Automotive Quality Systems Standard 5
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Commonizing use of Certification Body providers within a Global Organization Registrars and Notified Bodies 2
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1

Similar threads

Top Bottom