As has been the case with the EU MDD, all medical device products that have a CE mark need to have a technical file created, which proves that the device meets all the requirements of the EU directives for CE-marked products. Annex II of the new EU MDR includes revised requirements for what needs to be included in the contents, as well as the structure, or the technical file.
As per Annex II of EU MDR, the technical documentation needs to be clear, organized, readily searchable, and unambiguous. The elements to be include in the technical file are:
This practice matches with ISO 13485:2016 clause 4.2.3, which requires the device manufacturers to create a technical file, or a medical device file.
Jinhua Huacheng Medical Appliance Co.,Ltd.
Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode
