Announcement on the Significant Changes in the MDR Process
To the attention of all firms holding a certificate in the scope of the Medical Device Directive
As of May 26, 2021, Approved Institutions appointed under 93/42/EEC Directive will not be able to have another first certification but it has been announced on NANDO that they shall be responsible under Article 120 of MDR 2017/745/EU for the monitoring activities of valid certificates issued under 93/42/EEC Directive.
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