Hi folks,
As an aside to the issue of spare parts, I copy this from Actameds parent company in America.
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Dear Mr. Millitt:
Thank you for your recent inquiry with Actamed Limited regarding the Pre-Purchasing Questionnaire. From my understanding, you have a question about section 10 on the form as to why we have not provided a time period for guaranteeing spare parts availability and I wish to explain why.
As you may be aware, medical devices in the United Kingdom are regulated by the European Medical Device Directive 93/42/EEC. Under the guidelines of this directive, there are no defined requirements for providing spare parts for a set period of time after the manufactured date nor are there requirements for providing or guaranteeing spare parts. Since there are no defined requirements within the directive, we as a manufacturer are not obligated to define a set period for spare parts availability. We have typically handled the issue of spare parts availability through warranty terms, service contracts or general business terms within contract negotiation and tenders.
While the Medical Device Directive does not require guaranteeing spare parts, it is my understanding that there may be a national regulation or hospital specific guideline that dictates spare parts availability in the UK. Arizant Healthcare and Actamed are interested in learning more about any specific guidelines that cover spare parts requirements. With this in mind, we would like to request if you could please provide us with the name of the guidance document that defines spare parts requirements and how we may obtain it for further review. If you have this document, could you please send it to my attention? We would like to understand your need and how we can best meet it. By doing so, we can resolve this issue to our mutual benefit.
If you believe there is additional information related to this issue that may be relevant for us to be aware of, please feel free to provide us with that information as well.
I look forward to your cooperation.
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Any comments would be welcome, Pete
