Does this change impact the classification rule: Yes No 3. If “No” please justify: Section 4: Labelling and IFU 1. Is there a change to the Labelling/IFU Yes No Please supply a sample of the revised draft labelling & IFU in English 2. Location of the sample Label(s) & IFU in the supporting documentation Please clarify the exact nature of change(s) to the labelling/IFU based on the proposed 3. change(s) under review Are the requirements of EN 980 & EN 1041 being met Yes No 4. Version of Standard : Section 5: Solutions to Essential Requirements and Harmonised Standards Please indicate how relevant Essential Requirements (Annex I) of the Directive are met for the proposed changes. Location of the revised solutions to Essential Requirements in the supporting documentation FOR CLASS I STERILE devices: In particular ER 8 1. FOR CLASS I MEASURING devices: In particular ER 10
3. Does this change impact the classification rule: Yes No If “No” please justify: Section 4: Labelling and IFU 1. Is there a change to the Labelling/IFU Yes No Please supply a sample of the revised draft labelling & IFU in English 2. Location of the sample Label(s) & IFU in the supporting documentation 3. Please clarify the exact nature of change(s) to the labelling/IFU based on the proposed change(s) under review 4. Are the requirements of EN 980 & EN 1041 being met Yes No Version of Standard : Section 5: Solutions to Essential Requirements and Harmonised Standards Please indicate how relevant Essential Requirements (Annex I) of the Directive are met for the proposed changes. 1. Location of the revised solutions to Essential Requirements in the supporting documentation FOR CLASS I STERILE devices: In particular ER 8 FOR CLASS I MEASURING devices: In particular ER 10