MDR requirements for Co-branding

[MDRexpert]

Hi Everyone,

Can someone direct me MDR requirements for co-branding. What are the requirements and what article defines them.

Thanks!

 

[Ronen E]

Please kindly define "co-branding". It's not a term that appears in MDR or MDD.

 

[SKM.Sunil]

Hi Everyone,

Can someone direct me MDR requirements for co-branding. What are the requirements and what article defines them.

Thanks!

Please clarify the term.

do you mean to say OBL??

 

[MDRexpert]

Please clarify the term.

do you mean to say OBL??

Yes, I mean OBL. Thanks!

 

[dgrainger]

Article 16?

 

[SKM.Sunil]

Article 10 (4, 7, 8)
Both Manufacture and OBL should have TECHNICAL FILE WITH FULL ACCESS