Termination of Technical Agreements with OEM (OBL)

C

claireyvb

#1
Good morning all,

I have some technical agreements in place that need to be terminated as we no longer work with these companies. We occasionally receive feedback on these legacy Class 11a medical device products and as I understand it even if we terminate the agreement we (and the OEM) still need to abide by the requirements of the agreement.
Are there any regulatory requirements that I need to include in a termination of technical agreement letter?

Many thanks for your help in advance.
Claire
 
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pkost

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#2
For EU, you should consider collaborative communication communication for post market surveillance activities including complaint reporting, vigilence, clinical evaluation, FSCAs, recalls etc. Record keeping is also a must and you may want to require ongoing maintenance of the QMS in order to facilitate all these activities.

For the future I would suggest you amend your technical agreements to include clauses which indicate what happens when/if the agreement is terminated. This would make the process smoother and ensure people are aware of everything they are signing up to
 
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