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.

MDR and IVDR sampling criteria

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:

  • At least one representative device per generic device group for MDR Class IIb and IVDR Class C devices; and
  • At least one representative device for each category of devices for MDR Class IIa and IVDR Class B devices.

MDCG 2019-13 also clarifies related assessment responsibilities of Notified Bodies under Annex IX, Chapter II of both the MDR and IVDR.

MDR, IVDR codes for Notified Bodies

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:

  • MDA/MDN: pertain to device design and intended purpose; to be used for allocation of staff to review device technical documentation. These codes may target either a field of medical application or a device’s physical/technological principles.
  • MDS: applicable to devices with specific characteristics; used for allocation of staff for technical documentation reviews as well as for auditing special processes in some cases.
  • MDT: applicable to technologies and processes related to manufacturing of devices; used for allocation of manufacturing site auditors. MDT code assignment should be based on production processes for a device itself as well as for upstream production processes.

Learn more about European MDR and IVDR compliance at Emergo by UL:

  • European MDR compliance preparation and resource center
  • European CE Marking consulting for in-vitro diagnostic (IVD) manufacturers
  • On-site EU MDR training for medical device manufacturers
  • EU MDR gap assessment and transition strategy for medical device companies
  • Whitepaper: Understanding Europe’s Medical Devices Regulation
  • Whitepaper: The European In-vitro Diagnostic Medical Devices Regulation (IVDR)