The #MDCG has released a new questions and answers regarding Article 16 covering topics of repackaging and labelling.

Key Questions:

(1)    Do Article 16(3) and (4) of the MDR apply to ‘legacy devices’?

(2)    What information should be notified to the manufacturer according to the Article 16(4)?

(3)    What information should be notified to the competent authority according to the Article 16(4)?

 🔗 Original Document :  https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2021_26_en.pdf

 #MDRG #mdrguide #IVDR #MDR #medicaldevices #ec