Guidance on Article 54(2)b of Regulation (EU) 2017/745 on medical devices (MDR)

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