欧洲代表协议

MDD Agreement
We,«Company»
(hereinafter referred to as Company A)
and «EUrep»
(hereinafter referred to as Company B)
have agreed as follows with regard to the handling of all products (hereinafter called “Products”) manufactured and supplied by Company A to Company B in order to comply to the requirements set out in the COUNCIL DIRECTIVE 93/42/EEC Concerning Medical Devices (MDD) and “Guidelines on a Medical Devices Vigilance System”.
1.Appointment
Company A hereby appoints Company B, who accepts such appointment, as a representative for the “Business Area” and “Product Categories” set out in Appendix A. The responsibility of both parties are as stated hereafter.
2.Claim Handling
Company B shall be responsible to record all customer and market claims related to the products of Company A and transfer the information to Company A upon receiving of such claims.
3.Accident Handling
On receiving information of an incident (accident) or a near incident, as defined in the MDD 93/42/EEC and MEDDEV 2.12“Guidelines on a Medical Devices Vigilance System”, the following procedures shall be applied:
Company B shall report occurrence of an incident or near incident in its business area to Company A immediately.
Upon receiving information of an incident or near incident Company A shall
perform the necessary analysis of the situation and report to Company B. In that way Company B can report the analysis to the relevant Competent Authority as defined in the following time frame:
within 10 days after receiving first information of an incident
within 30 days after receiving first information of an near incident
Based on the analysis Company A shall instruct Company B of the necessary countermeasures to be taken. Company B shall inform the relevant Competent Authority and customer as required in the countermeasure plan issued by Company A.
4. Traceability of Sold Products
Company A shall keep records of serial numbers or production lot numbers for all Products delivered to Company B.
Company B shall keep records of the Products delivered to end-users or distributors so that the traceabilitry of sold products can be performed at any time upon request. Records shall include the following information :
a)name and address of the customer
b)quantity dispatched
c)date transferred to the customer
d)serial or production lot numbers
It is agreed that these records shall be available for inspection upon request by Company A or by the relevant authorities.
5. Technical Documentation
Company A shall establish necessary procedures to prepare and maintain Technical Documentation including the Declaration of Conformity for the “Product Categories” set out in Appendix A to be able to comply with the MDD requirements.
Company A shall transfer the agreed Technical Documentation and Declaration of Conformity to Company B.
Company B shall maintain the Technical Documents including the Declaration of Conformity available to the relevant Competent Authority for at least five years after the last product has been sold.
Company A shall have the responsibility to provide to Company B any additional documentation as required by the Competent Authority.
6. Instruction Manual
Company A shall be responsible for the content of instruction(user’s) manuals, and shall ensure that English language instruction manuals are available to Company B. Company B shall ensure that the required local language instruction manuals are provided to the customers.
(Appendix A)
The following countries represent Company B’s Business Area :
Europe
For the following Product Categories :
Company A: _____________ ____________ __________________ date place signature
Company B: _____________ ____________ __________________ date place signature。