MDR requirements for labelling of Sterile Medical Products:‘Sterile Barrier System Indication’and ‘Check the IFU’
The Medical Device Regulation 2017/745 (MDR)establishes a new requirement for labellingthe sterile barrier systems (SBS) of medical devicesto be recognized as such. This shall assist end-users to unwrap respectively open the sterile packaging in an aseptic manner. The MDR introduces also another new labelling requirement to refer to instructions for use in case of damage to the sterile packaging:‘MDR, Annex I, Article 23.3.:23.3. Information on the packaging which maintains the sterile condition of a device ('sterile packaging')The following particulars shall appear on the sterile packaging:(a)an indication permitting the sterile packaging to be recognized as such...(j)an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use.The MDR sets high standards of quality and safety for medical devices, and (sterile) Medical Products which will beplaced on the market under therules of the MDR have to be labelled with the information required in Article 23.3.The above cited labelling requirements are new, and no symbols exist yet to fulfill this clause of the Medical Device Regulation.