This appears to me to be similar to using internal audit to self-declare issues with your QMS. If you are aware of the issue and taking actions (correction and corrective action) and you are showing progress, it is unlikely that you will receive a nonconformance for the issue. However, you need to have the plan and show progress. This does not mean it is not nonconforming and the issue remains until you have taken the action, it simply means that they aren't going to force action (let your system work). The fact remains, you need to take action toward conformity. As long as I can see you doing that, I wouldn't write this up during an audit as a nonconformity, just an observation with a plan for review at the next audit (again looking for adequate progress). This is the practical risk based approach. Hopefully that clarifies.
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Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE MBA
Becker MN
United States
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Original Message:
Sent: 08-Aug-2017 11:57
From: Anonymous Member
Subject: Transitions: MEDDEV 2.7/1 Rev 3 vs Rev 4 vs MDR
This message was posted by a user wishing to remain anonymous
Dear All,
I am hoping you can provide some insight on NB expectations/interpretations regarding the MDR and the state of the art for conducting a CER as described in MEDDEV 2.7/1. In our view, it is unusual for an NB to provide a transition timeline for adherence to a MEDDEV, but these are unusual days. The below is a "Dear Client" letter from TÜV SÜD. Please share any similar experiences from other NBs.
Thanks in advance!
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On May 5, 2017, the new medical device regulation was published with a transition period of 3 years. Due to this fact and the fact that this regulation includes specific clinical requirements which are not consistent with the MEDDEV Guidance Document on clinical evaluation (MEDDEV 2.7/1 Rev. 4), TÜV SÜD decided to extend the implementation timeline for the reflection of the state-of-the-art methods of clinical evaluation. This decision was taken to allow medical device manufacturers to use their resources effectively when adopting the upcoming changes with the new regulation to their clinical evidence documentation. This extension is just possible if the requirements on clinical evaluation and active post-market surveillance of the applicable directive MDD and/or AIMDD are fulfilled. In particular, the following timelines are applicable from today: July 31, 2017 – May 25, 2020
- Every submission can still follow the currently used methodology reflected in the MEDDEV 2.7/1 Rev. 3 or another comparable method
- Every submission shall include a plan on how to reflect the current state-of-the-art method for clinical evaluation (i.e., MEDDEV 2.7/1 Rev. 4 or another comparable method)
- Every technical documentation that is selected in this period shall either include a plan for the reflection of state-of-the-art methodology implementation as presented, for example, in the MEDDEV 2.7/1 Rev. 4, or be part of a general plan of the manufacturer
May 26, 2020
- Every CER which is signed after May 26, 2020, shall be reflecting the current state-of-the-art method of clinical evaluation by either following the Rev. 4 of the MEDDEV or another comparable method
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