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Mercian is approved to transition to the MDR

Posted by Mercian Surgical on May 21, 2024 12:20:56 PM

As part of our transition to the new EU MDR Regulations 2017/745 replacing our MDD Directive Mercian are delighted to announce formal approval by our Notified Body SGS Belgium to extend our current MDD certificates for our Class II devices until 31st of December 2028 to allow time for us to transition to the MDR Regulations.

This is in accordance with section 4.3, second subparagraph of Annex VII of the MDR Regulations.

A copy of our extension letter confirming this formal status can be view or downloaded from our Quality page from our website.



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