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Guidance for dealing with "old" devices

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Guest user Created:   Dec 09, 2021 Last commented:   Dec 13, 2021

Guidance for dealing with "old" devices

We have been marketing our devices in the EU since 2011 and have records and survaillance of these Class I devices since that time.  These devices are cleansing devices for the eyelid, eyelashes and area around the eye but not for the eye itself.  We also market a device called *** whose active ingredient is Tea Tree Oil in very low quantity or percent concentration.  According to the guidance for Legacy devices MDCG 2021-25 issed October 2021, these devices are not considered "New' devices (devices to be submitted under the MDR and new to the EU market) nor or they considered " Legacy" devices (devices who were introduced to the market during the development of the MDR but before May 26, 2021.  Our devices according to this guidance are considered "OLD" devices  and defined as those devices that were placed on the market before 26 May 2021 in accordance with the AIMDD or the MDD or in accordance with the applicable rules before the directive had entered into force. .  Is there a guidance for these "old" devices.
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Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Dec 13, 2021

Your guidance is MDR itself. It means that if you are a class I device, that from 26th May 2021. you need to be in compliance with the MDR, The only excuse for that is the implementation of the UDI number, which must be applied until May 2025, as stated in Article 123 Entry into force and date of application.  

For more information, see:
 
EU MDR Article 123 Entry into force and date of application https://advisera.com/13485academy/mdr/entry-into-force-and-date-of-application/

 

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Dec 09, 2021

Dec 13, 2021