Technical Documentation Review & Verification
The new EU Regulations on medical devices and in-vitro diagnostic medical devices (IVD’s) require that the Authorised Representative verifies and checks that the technical documentation relating to a Medical Device, or an In-Vitro Diagnostic Medical Device, complies with EU regulatory requirements before it is placed on the market.
In the case of our EU Authorised Representative service it will be a legal requirement for us, if we are your EU Authorised Representative, to verify that the technical documents has been drawn up, and where applicable, that an appropriate conformity assessment procedure has been carried out, and that they comply with legal requirements. It is important to note that we will also be obliged to have access to manufacturers’ technical documentation at all times.
Therefore, a non-EU manufacturer of medical devices or IVD’s will be required to submit their technical documentation to their EU Authorised Representative for verification before the CE mark is applied and, importantly, before the Authorised Representative Mandate is a legal contract.
To have your documentation verified by Advena as competent consultants, whether you are an Authorised Representative client or not, will assist you in meeting your product liability requirements which are now so important.