Certification of OEM Medical Devices

[Olgamargarita]

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??

 

[Marc]

There has been a request for you to rephrase your question for clarity.

Thanks!

 

[Olgamargarita]

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]

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]

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

 

[somashekar]

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

 

[Olgamargarita]

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]

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.

 

[MIREGMGR]

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]

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