The Med­ical Device Coor­di­na­tion Group (MDCG) has pub­lished a guid­ance doc­u­ment on the inter­pre­ta­tion of arti­cle 54(2)b of the MDR. The afore­men­tioned arti­cle pro­vides cri­te­ria for the exemp­tion of med­ical devices from the pre-mar­ket clin­i­cal eval­u­a­tion con­sul­ta­tion procedure.

The guid­ance doc­u­ment specif­i­cal­ly refers to ambi­gu­i­ty regard­ing point b in which devices are exempt from the con­sul­ta­tion procedure 

“where the device has been designed by mod­i­fy­ing a device already mar­ket­ed by the same man­u­fac­tur­er for the same intend­ed pur­pose, pro­vid­ed that the man­u­fac­tur­er has demon­strat­ed to the sat­is­fac­tion of the noti­fied body that the mod­i­fi­ca­tions do not adverse­ly affect the ben­e­fit-risk ratio of the device”.

MDCG guid­ance on arti­cle 54(2) of the MDR

The doc­u­ment states that “device already mar­ket­ed” in this con­text does not mean that a device had to be unique­ly mar­ket­ed under the MDR, but pos­si­bly also under the Med­ical Devices Direc­tive 93/42/EEC (MDD).

Should you require the full ver­sion of the MDCG doc­u­ment or fur­ther infor­ma­tion, please get in touch. 

Please note that any infor­ma­tion pro­vid­ed in the doc­u­ment is not legal­ly bind­ing although it reflects the opin­ion of the Euro­pean Commission.

Source: MDCG guid­ance on arti­cle 54(2) of the MDR