MDCG publishes paper addressing notified body capacity

Article summary

The Medical Device Coordination Group (MDCG) has published a position paper about the concerns with the lack of notified body capacity and availability of medical devices and in vitro diagnostic devices. The position paper lists measures to enhance notified body capacity, access to notified bodies and manufacturers’ preparedness to facilitate transition to Regulation (EU) 2017/745 (the Medical Devices Regulation (MDR)) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation (IVDR)) and measures to avoid shortage of medical devices. In order to increase notified bodies’ capacity, the MDCG advises notified bodies to make use of hybrid audits, develop a framework for leveraging evidence from previous assessments conducted with regard to requirements under Directive 93/42/EEC (the Medical Devices Directive) and Directive 98/79/EC (the In Vitro Diagnostic Medical Devices Directive) for the purpose of conformity assessment procedures under the MDR and the IVDR, and make full use of the flexibility described in MDCG 2022-4 on appropriate surveillance under Article 120(3) of...