Guidance documents are by definition not compulsory. However, all guidance
documents endorsed by the MDCG reflect the interpretation of the EU law jointly
agreed by the authorities which are in charge of interpreting and applying the EU law.
Hence notified bodies should be encouraged to apply these guidance documents
(also taking into consideration Section 1.6.2 of Annex VII to the MDR/IVDR1).
Furthermore, it is to be noticed that the European Court of Justice often refers to
guidance documents when developing its rulings. Hence Notified Bodies have an
interest, also in terms of liability risk, to follow that guidance…
