I wish I could help you more, but I don't know enough about this topic. I suggest you talk to a Regulatory person to be safe.
Also, when you say the products will be manufactured by a company with ISO 13485, it sounds like you are using a contract manufacturer. Regardless of whether you use a contract manufacturer, you will have regulatory responsibility over your product. You will have to ensure that your product meets the essential requirements of the 93/42/EEC.