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AnnouncementPrinters

MDR (EU) 2017/745

By July 16, 2021February 10th, 2022No Comments
From May the 26th of 2021, MDR (EU) 2017/745 becomes mandatory for Medical Devices. For this reason, Mitsubishi Electric will stop placing the P93, P95, CP30 and CP31 printer series on the market as medical device on and after May 26th 2021 due to expiration of MDD. After this date, those printers will declare EU compliant as ITE equipment but continue to comply with safety and EMC standards for medical equipment (EN60601-1, EN60601-1-2).

Please note that Product Categories of EEE for 2011/65/EU for the P93, P95, CP30 and CP31 printer series will change from 8. Medical Devices to 3. IT and Telecommunications Equipment.

Thermal papers will still comply with MDD as consumables for the printer that was placed on the market before MDD has expired.

Download updated Declaration of Conformity documents from here: EU, UK

Technical Support Team

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