TAKEAWAYS FROM MDCG 2020
DID YOU KNOW?
- the MDR allows for a Technical Equivalence with a similar design rather than the same (which was specified in MED DEV 2.7/1 Rev 4)?
- the MDR expands on the description of Biological Equivalence from MED DEV 2.7/1 Rev 4, adding similar kind/duration of contact and similar release characteristics of substances? (which was specified in MED DEV 2.7/1 Rev 4)
- the MED DEV 2.7/1 Rev 4 only allowed a single CE marked device to be used as the equivalent device, but MDR allows for the use of more than equivalent device, but each device under evaluation shall be equivalent in all the listed technical, biological and clinical characteristics.
“The assessment of whether any differences in characteristics would result in clinically significant difference in safety and clinical performance shall also be duly substantiated and based on proper scientific justification. This assessment may be supported by e.g. clinical data from the scientific literature, common specifications (CS)36, harmonized standards or other established technical specifications”
MDR has additional requirements in addition to equivalence in order to not perform a clinical investigation –
“A manufacturer of implantable devices and class III devices shall perform clinical investigations except if the device has been designed by modifications of a device already marketed by the same manufacturer and equivalence can be demonstrated according to the MDR”39.
Exceptions for equivalence devices, other than implantable and class III, can be considered, and equivalence claimed to a device that is not CE-marked, provided all relevant MDR requirements regarding equivalence and clinical evaluation can be met.
- That the manufacturer shall have sufficient levels of access to the data relating to devices with which they are claiming equivalence41 . In the circumstance that the presumed equivalent device is from another manufacturer, there is no MDR requirement of a contract between the manufacturers for regulating the access to the technical documentation.
- That clinical investigations were conducted in accordance with international guidelines42
- That the clinical data meet the requirements of the MDR, and a justification is provided whether the clinical data are transferrable to the European population.