MDCG position paper published for manufacturers who, despite all reasonable efforts, cannot achieve EU MDR certification in time.

?Articles 94 and 97 of the EU MDR provide a mechanism for requesting a competent authority to review a device which does not conform to the EU MDR, but does not present an unacceptable risk to health and safety. This is a mechanism that may be used by manufacturers who, despite all reasonable efforts, have not been able to secure EU MDR certification before their existing EU MDD certification has expired. Over recent months we've helped manufacturers successfully use this route.

Where a device is nonconforming to the EU MDR because it has not successfully completed conformity assessment, the competent authority may allow a period of time for the device to be brought back into conformity. MDCG 2022-18 now provides the information needed by manufacturers, their authorised representatives and the competent authorities to keep products that do not present an unacceptable risk to health and safety on the EU market. This is a much-needed coordinated approach to maintain patient care, and a vital lifeline to many manufacturers who have not been able to secure or complete their EU MDR certification process due to external delays or resource constraints within the certification system.

Written by - Caroline Timberlake