Being registered to ISO 13485 for the manufacture of medical devices, our systems and procedures enable LSL to register and subsequently label an In Vitro Device (IVD) as a Class 1 device, and we have indeed registered several and labelled several accordingly.  Labelling is not allowed without the registration of each device. Unfortunately the directive does not allow all such devices to be registered.

To be able to register a device we need to be able to demonstrate - device history, QA system history, performance evaluations, literature (including manufacturing and inspection records), risk analysis, manufacturing rules (S.O.P.s and protocols), national and international registrations and approvals, user experience, and experience in the post-production stage.Our systems and procedures satisfy all of those requirements but the risk analysis element. For product where we are aware of all uses (e.g a blood collection tube, culture vials) we can carry out a detailed risk analysis, and for those type of device we have registered. 

Our difficulties come in two areas

1. We cannot carry out a risk assessment for a multi-purpose product without knowing the full use and application of that product in one field.  If, however, a customer would like a product to be CE marked, and they know its specific use or application, then we could work together to produce a risk analysis and get their product registered for that use.  Unless the product is seen as a component.
   
2. No one is allowed to CE mark any product that is or could be used as a component, typically diagnostic vials that are used to make up kits.  That responsibility lies with the end manufacturer/assembler, but we are able to provide all the above records and traceability to anyone who is CE marking a product to which we supply our vials. Information is available on request.