The Medical Device Coordination Group (MDCG) released a new position paper on the transition to the Medical Devices Regulation (MDR) and In Vitro Devices Regulation (IVDR) this August. Addressing the existing challenges of notified body capacity to certify medical devices and in vitro diagnostic devices, this document lists several actions to avoid a shortage of medical devices.
To enhance notified bodies’ capabilities, the MDCG includes recommendations on:
- the use of hybrid audits in an efficient manner;
- conformity assessment procedures;
- surveillance activities of legacy devices.
Among others, the position paper includes commitments by the MDCG to review its guidance to remove the administrative workload of notified bodies under MDR and IVDR. In addition, further proposals are adding codes to the designation of notified bodies, and the revision of the previous guidance (namely section III.6 of MDCG 2019-6 Rev. 3).
Furthermore, the Medical Device Coordination Group aims at simplifying the access to notified bodies for manufacturers. For instance, it stresses out the necessity to take into account the interests of SMEs concerning fees. Especially, SME manufacturers and first-time applicants have be able to have access to conformity assessment procedures.
On the other hand, this document also addresses manufacturers. Indeed, manufacturers are invited to consult guidance Notice to manufacturers to ensure timely compliance with MDR requirements and to focus on the importance of communication with notified bodies.
Eventually, the document also suggests:
- increasing the flexibility of the conformity assessment of legacy devices;
- providing additional guidance to both notified bodies and manufacturers;
- elaborating further definitions for “orphan devices” to meet legal requirements;
- to medicines authorities, expediting the review of consultations by notified bodies regarding medical devices incorporating an ancillary medicinal substance and companion diagnostics.
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