The MDCG has updated a guidance document initially released in 2021 regarding Article 13 and 14 of the MDR and IVDR concerning the obligations of importers and distributers. The updates that have been published in this revision include the addition of a number of questions. These include:
- Question 11 regarding the fulfilment service providers
- Question 16 regarding the role of authorised representatives and importers
- Question 17 regarding the role of importer and distributer
- Question 24 regardingsystem and procedure packs and the importer role
- Question 25 regarding system and procedure packs and the distributor role
- Question 26 regarding leasing companies
The updated guidance document can be accessed using the following link
