Can anyone share a Distribution Agreement template under MDR 2017/745?

[Azhar Anwar]

I work for a medical device company. need to update Distributor agreement documents per medical device regulation.
I would appreciate very much any template document. Thanks in advance.

 

[npl1304]

I'm also interested in template of Distributor agreement.
Than you all

 

[Cybel]

Hi, my MDR Agreements with distributors are organized as follows:
- manufacturer data and distributor data with signatures
- QTA review code and number, date
- scope of the agreement
- definitions taken from Regulation (EU) 2017/754, art. 2
- overall responsibilities of the parties with reference to:
a) article 14 - responsibility of manufacturer and distributors, detailed for each point of article 14
b) article 16 - responsibility of manufacturer and distributors, detailed for each point of article 16
c) art. 25 - responsibility of manufacturer and distributors, with reference to traceability
Hope it helps.
Of course, this covers only MDR requirements; other issues (such as technical issues, prices, quantities..) are described in other agreements.

 

[npl1304]

thank you

 

[Chani]

Hi there , I'm a new RAQA manager in a medical device company. They currently have no agreements in line with Article 14 of 2017/745. I need to get my facts together to present to top management why this is a requirement. Other than from experience, I can't find any hard evidence. Can anyone assist ?

 

[yodon]

How about 13485:

4.1.5 When the organization chooses to outsource any process that affects product conformity to requirements, it shall monitor and ensure control over such processes. The organization shall retain responsibility of conformity to this International Standard and to customer and applicable regulatory requirements for outsourced processes. The controls shall be proportionate to the risk involved and the ability of the external party to meet the requirements in accordance with 7.4. The controls shall include written quality agreements.

 

[Apoorva]

Hi Cybel

Thank you sharing the information, Can you please share the complete information on distributor agreement if possible.

Thank you.