Why Did The MDD Need To Be Updated

Aug 02, 2021 Leave a message

The MDD came into law in 1992, and is therefore outdated. For example, Software as a Medical Device (SaMD) did not yet exist. Furthermore, apps that patients used to monitor their own health did not yet exist.

The average age in Europe has also seen an increase since 1992, and this brings greater risks in medical device malfunction. To combat this, MDR has put stricter regulations on product life cycle, in order to increase overall product hygiene. Since 1992, people have also become more conscious of their health. With these factors, there has been more demand from the consumer for transparency of medical device technical information (greenlight, 2019).


Jinhua Huacheng Medical Appliance Co.,Ltd.

Manufactuer of disposable medical products: Electrosurgical pencil,grounding plate,skin stapler and ECG electrode

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