Dec 18, 2019
Two new guidance documents from European regulators address sampling criteria for medium-risk medical devices and IVDs, and clarify Medical Devices Regulation (MDR) codes for designation of Notified Bodies to the Regulation.
First, the European Medical Device Coordination Group’s (MDCG) MDCG 2019-13 guidelines provide definitions of sampling criteria for Class IIa and IIb medical devices under the MDR, as well as for Class B and C IVD products under the In-vitro Diagnostic Medical Devices Regulation (IVDR).
Both new Regulations require assessment of technical documentation of:
MDCG 2019-13 also clarifies related assessment responsibilities of Notified Bodies under Annex IX, Chapter II of both the MDR and IVDR.
Second, MDCG’s MDCG 2019-14 guidance clarifies information regarding codes used for designation of Notified Bodies under the new Regulations.
These codes are designed for use by European authorities to define the scope of Notified Body designations under the MDR and/or IVDR, as well as by Notified Bodies themselves to indicate their staff qualifications as well as qualifications necessary for particular device assessments.
“These codes may be very broad and, furthermore, unequivocal authorisation of personnel to codes and the assignment of codes to a device is not always straightforward,” states MDCG in the document. “However, the notified body’s system needs to ensure, in all cases, that the authorisation of personnel and team allocation for the conformity assessment of a device ensures adequate knowledge and expertise.”
The document lays out three main code types:
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