Good Evening,
.the following section of the EUMDR (Article 61. (5)) applies - as far as I see - on the OBL-OEM relationship:
"5. A
manufacturer (OBL) of a device demonstrated to be equivalent to an already marketed device not manufactured by him (OEM), may also rely on paragraph 4 in order not to perform a clinical investigation provided that the following conditions are fulfilled in addition to what is required in that paragraph:
- the
two manufacturers have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis, and
- the original clinical evaluation has been performed in compliance with the requirements of this Regulation,
and the manufacturer of the second device provides clear evidence thereof to the notified body.
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Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
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Original Message:
Sent: 18-Nov-2017 05:52
From: Sofia Panagou
Subject: EU OBL concept according to MDR
Thanks dearly for your response!
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Sofia Panagou
QA/RA Manager
Leoni Fiber Optics Gmbh
Berlin
Germany
Original Message:
Sent: 17-Nov-2017 12:00
From: Ary Saaman
Subject: EU OBL concept according to MDR
Sofia :
I am not a real expert in this particular OBL-OEM area. Yet, various presentations I attended about the MDR and its impact on OBL's have highlighted :
- OBL must have (access to) the full technical file, including e.g. sterilization validation at subcontractors of the OEM
- Access to OEM's PMS data
- Full audit and supply chain oversight
- Unannounced audits
Are you familiar with the following document by the MHRA : Virtual Manufacturing replaces Own Brand Labelling for medical device manufacturers (Version 1.0 of March 2017) ?
Although applicable under the MDD, upon closer reading, it might well be or close to what is to be expected under the MDR.
Again, I am no true expert in these matters, but hope this is useful. With kindest regards,
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Ary Saaman
Director, Regulatory Affairs
Debiotech S.A.
Lausanne
Switzerland
Original Message:
Sent: 17-Nov-2017 04:50
From: Sofia Panagou
Subject: EU OBL concept according to MDR
Dear colleagues,
We try to explain to our management boarding what the impact of the Medical Device Regulation to the OEM-OBL contracting in the EU will be and we would appreciate your input.
Please share your knowledge and thoughts.
Best regards,
Sofia Panagou