Thulasidharan
Starting to get Involved
Hi All,
Need Clarification on MDR - Article 18(d)
(d) any other information to ensure safe use of the device by the patient, including the information in point (u) of Section 23.4 of Annex I.
(u) in the case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients can be exposed;
what the exact thing have to be presented?..
Need Clarification on MDR - Article 18(d)
(d) any other information to ensure safe use of the device by the patient, including the information in point (u) of Section 23.4 of Annex I.
(u) in the case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients can be exposed;
what the exact thing have to be presented?..