EU: New guidance relating to the MDR

The EU has published two additional guidance documents in the form of MDCG 2019-13 and MDCG 2019-14.

MDCG 2019-13 explains the sampling method used by the notified bodies for the assessment of technical documentation for products in Class IIa and IIb. The assignment of the products to the MDR codes and/or to the new medical device nomenclature (EMDN) is key.

In addition to this, MDCG 2019-14 details the procedure for assigning the MDR codes, both for specifying the scope of the notified bodies and for their employees' qualifications, as well as classification of the medical devices by the manufacturer.

Go back