2021.11.09
The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations.
Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG) in accordance with Article 105 of Regulation 745/2017, pursue the objective of ensuring uniform application of the relevant provisions of the regulations within the EU.
Guidance on classification of medical devices.pdf
Q&A on repackaging & relabelling activities.pdf
Application of MDR requirements to legacy devices.pdf
All the information can be found here.
Comments