Thanks Jennifer, I appreciate your follow-up! We just heard similar information regarding BfArM from our EUAR, which is great news. From our experience BfArM is among the most stringent CAs, so hopefully this means other CAs are following the same model.
I am hopeful that BfArM will eventually stop requiring the individual report form once Eudamed is up and running, but we have a while to wait for that!
Thanks again,
Jennifer
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Jennifer Cabralda, RAC (US, CAN)
Director, Regulatory Affairs
Richmond, BC, Canada
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Original Message:
Sent: 06-May-2021 08:16
From: Jennifer Kratz
Subject: MEDDEV 2.7/3 Transition to MDCG 2020-10-02
Hi Jennifer,
My company received a response from BfArM that they would like to have all of the data points entered onto MDCG 2020-10/2 for old SAEs but they understand that all the data may not be readily available. So it is not mandatory for old SAEs but it is mandatory for any being reported on or after 26MAY. BfArM also indicated that they will still require the completion of their SAE report form and also quarterly reporting.
Hope this helps!
Kind regards,
Jennifer
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Jennifer Kratz
Director, Safety Services
Clinlogix LLC
Lower Gwynedd PA
United States
Original Message:
Sent: 03-May-2021 20:11
From: Jennifer Cabralda
Subject: MEDDEV 2.7/3 Transition to MDCG 2020-10-02
Hi Jennifer – any chance you have an update from the two competent authorities you contacted (and if so, are you willing to share which ones)? I am also very interested in the answer to this question.
Thanks,
(Another) Jennifer
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Jennifer Cabralda, RAC (US, CAN)
Director, Regulatory Affairs
Richmond, BC, Canada
Original Message:
Sent: 16-Apr-2021 12:11
From: Jennifer Kratz
Subject: MEDDEV 2.7/3 Transition to MDCG 2020-10-02
Many thanks, Neil.
Your assessment is helpful and your approach neutralized the risk of non-compliance. We have contacted 2 Competent Authorities and if/when I receive a response, I will share it with you.
Best regards,
Jen
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Jennifer Kratz
Director, Safety Services
Lower Gwynedd PA
United States
Original Message:
Sent: 16-Apr-2021 03:30
From: Neil Armstrong
Subject: MEDDEV 2.7/3 Transition to MDCG 2020-10-02
Hi Jennifer:
We looked into this a couple of months ago and concluded that it was not clear whether additional recording requirements applied to all subjects in trials completing after the date of application (DoA), or those treated after the DoA, or just those recruited after the DoA or indeed not to any trial authorized under prior legislation. In discussion with our Competent Authority, their view was that if a trial was authorized under the MDR and/or completed after the DoA, all MDR requirements applied. Again MDR is already law and can be used, it is just that it becomes mandatory on the DoA. Our decision was, the addition recording burden was not that great and it was better to record the additional items. FYI we completed that trial early, so we could have done it under the old requirements, but we have hopefully eliminated any questions about validity in future use of the data by complying with the latest legislation.
Hope that helps
Neil
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Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom
Original Message:
Sent: 15-Apr-2021 17:33
From: Jennifer Kratz
Subject: MEDDEV 2.7/3 Transition to MDCG 2020-10-02
Hello,
I am preparing MDCG 2020-10-02 tables for ongoing clinical trials that have been using MEDDEV 2.7/3 tables to report SAEs to the EU Competent Authorities.
The new MDCG 2020-10-02 table requires more information for each SAE than the MEDDEV 2.7/3 table. Do I need to add all the new data points like age and gender for each SAE that was reported to EU Authorities prior to 26MAY2021? Or can I just include this information for new initial SAE reports submitted after 26MAY2021?
Thanks!
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Jennifer Kratz
Director, Safety Services
Lower Gwynedd PA
United States
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