I didn't say that.
I just highlighted that there is no such explicit requirement in the MDD itself. I thought that this is what you asked.
I'm not involved enough in the intricacies of accreditation schemes to take one side or the other. I was hoping that the UKAS webpage would quickly clarify it but as I noted medical devices aren't among the fields explicitly listed there. Perhaps there are clear answers somewhere else but I don't currently have the time to chase them. Hopefully someone more involved could quickly point out an appropriate reference.
Sorry,
Ronen.
I just highlighted that there is no such explicit requirement in the MDD itself. I thought that this is what you asked.
I'm not involved enough in the intricacies of accreditation schemes to take one side or the other. I was hoping that the UKAS webpage would quickly clarify it but as I noted medical devices aren't among the fields explicitly listed there. Perhaps there are clear answers somewhere else but I don't currently have the time to chase them. Hopefully someone more involved could quickly point out an appropriate reference.
Sorry,
Ronen.
Specific guidance for UK Notified Bodies is here.
The relevant section on conformity assessment is (IMHO) Section 5 - Facilities and it says:
(A) Extent
The notified body shall have available the appropriate facilities to enable it to carry out the assessment and verification activities for which it has been notified.
The notified body shall have available the appropriate facilities to enable it to carry out the assessment and verification activities for which it has been notified.
The facilities should enable the notified body to perform the technical and administration tasks connected with evaluation and verification, whether those tasks are carried out by the notified body itself or under its responsibility (see also section 8). If verification and testing procedures require use of technical equipment normally controlled and used by the manufacturer, the notified body should be able to demonstrate that it both had access to, and full control of, the equipment during the relevant procedures.
Section 8 provides further guidance on the NoBo's use of subcontractors. I don't believe that addresses the case Michelle has raised here.
Hope this helps.
