Posted 13 May 2020 | By
The European Commission’s Medical Device Coordination Group (MDCG) on Wednesday released a new guidance explaining how safety reporting in clinical investigations of medical devices should be performed under the Medical Devices Regulation (MDR).
The guidance comes after both the date of application of the MDR and the launch of Eudamed were delayed by one and two years, respectively. (RELATED: MDR delay official as industry calls to push back IVDR, Regulatory Focus 24 April 2020; Eudamed’s 2-year delay: CAMD executive group calls for interim solutions, Regulatory Focus 2 December 2019).
“Since the electronic system referred to in Article 73 (Eudamed) will not be available and fully functional at the date of application of the MDR this guidance outlines the procedures for safety reporting in clinical investigations in the absence of Eudamed,” MDCG writes.
MDCG says the guidance applies to premarket clinical investigations of non-CE marked devices, CE marked devices used outside their intended uses and device studies covered under MDR Article 82.
The guidance also applies to certain postmarket clinical follow-up investigations, specifically those that involve procedures outside the normal conditions of use of the device and those that impose additional procedures that are invasive or burdensome.
MDCG clarifies that some other postmarket clinical investigations “may be subject to safety reporting requirements in line with this guidance due to national requirements following MDR Article 82, but there is no such general requirement,” and encourages sponsors to check with the appropriate national competent authority to determine what reporting procedures should be followed.
Additionally, the guidance applies to trials initiated under the Active Implantable Medical Devices Directive and the Medical Devices Directive. “These investigations may continue to be conducted after the date of application of the MDR, but the reporting of serious adverse events and device deficiencies shall be carried out in accordance with the MDR requirements from 26 May 2021 and onwards,” MDCG writes.
MDCG also says the guidance is relevant to medical devices used in clinical trials for medicinal products, unless the study is not meant to assess the safety or performance of a CE-marked device and the device is used according to its intended purpose.
From the date of application of the MDR, 26 May 2021, MDCG says that a new summary reporting form should be used for reportable events and new findings or updates to already reported events.
MDCG says the requirement to perform safety reporting via Eudamed will kick in 6 months after a notice regarding Eudamed’s functionality has been published in the Official Journal of the European Union according to MDR Article 34(3).
Once the transition to Eudamed begins, MDCG says that sponsors should continue to submit follow-up and final reports to the national competent authorities using the same procedure used to submit the initial reports and that all new reportable events should be submitted to Eudamed.
“Whether retrospective uploading of previous event reports to Eudamed will be possible is not clear at the time this guidance is issued,” MDCG writes.
The guidance goes on to explain what events are considered reportable under MDR Article 80(2); requirements for reportable events occurring in third countries; what individuals and entities are required to report and to whom; as well as reporting timelines based on the seriousness of the event.
Guidance
The guidance comes after both the date of application of the MDR and the launch of Eudamed were delayed by one and two years, respectively. (RELATED: MDR delay official as industry calls to push back IVDR, Regulatory Focus 24 April 2020; Eudamed’s 2-year delay: CAMD executive group calls for interim solutions, Regulatory Focus 2 December 2019).
“Since the electronic system referred to in Article 73 (Eudamed) will not be available and fully functional at the date of application of the MDR this guidance outlines the procedures for safety reporting in clinical investigations in the absence of Eudamed,” MDCG writes.
MDCG says the guidance applies to premarket clinical investigations of non-CE marked devices, CE marked devices used outside their intended uses and device studies covered under MDR Article 82.
The guidance also applies to certain postmarket clinical follow-up investigations, specifically those that involve procedures outside the normal conditions of use of the device and those that impose additional procedures that are invasive or burdensome.
MDCG clarifies that some other postmarket clinical investigations “may be subject to safety reporting requirements in line with this guidance due to national requirements following MDR Article 82, but there is no such general requirement,” and encourages sponsors to check with the appropriate national competent authority to determine what reporting procedures should be followed.
Additionally, the guidance applies to trials initiated under the Active Implantable Medical Devices Directive and the Medical Devices Directive. “These investigations may continue to be conducted after the date of application of the MDR, but the reporting of serious adverse events and device deficiencies shall be carried out in accordance with the MDR requirements from 26 May 2021 and onwards,” MDCG writes.
MDCG also says the guidance is relevant to medical devices used in clinical trials for medicinal products, unless the study is not meant to assess the safety or performance of a CE-marked device and the device is used according to its intended purpose.
From the date of application of the MDR, 26 May 2021, MDCG says that a new summary reporting form should be used for reportable events and new findings or updates to already reported events.
MDCG says the requirement to perform safety reporting via Eudamed will kick in 6 months after a notice regarding Eudamed’s functionality has been published in the Official Journal of the European Union according to MDR Article 34(3).
Once the transition to Eudamed begins, MDCG says that sponsors should continue to submit follow-up and final reports to the national competent authorities using the same procedure used to submit the initial reports and that all new reportable events should be submitted to Eudamed.
“Whether retrospective uploading of previous event reports to Eudamed will be possible is not clear at the time this guidance is issued,” MDCG writes.
The guidance goes on to explain what events are considered reportable under MDR Article 80(2); requirements for reportable events occurring in third countries; what individuals and entities are required to report and to whom; as well as reporting timelines based on the seriousness of the event.
Guidance
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