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.