| Theme | Consultation procedure within the framework of clinical evaluation |
| Target Audience | Manufacturers, Notified Bodies |
| Products Concerned | – Class III implantable MD
– Active Class IIb MD intended to deliver/remove a drug to/from the body |
| Regulatory reference | MDR (EU) 2017/745
Article 54(2)b |
| Documents mentioned |
This MDCG document clarifies one of the cases in which the consultation procedure in the context of the clinical evaluation does not apply : “when the device has been designed by modifying a device already marketed by the same manufacturer for the same purpose provided that the manufacturer has demonstrated to the satisfaction of the notified body that the modifications do not adversely affect the risk/benefit balance of the device“. The MDCG clarifies that the notion of “already marketed” refers to both marketing under the Directives and under the Regulation.
It also clarifies that for devices marketed under the Directives, the notion of modification is to be understood as any modification necessary to comply with the new requirements of the MDR.