Hello Colleen,
The time needed to develop a clinical evaluation plan (CEP) will depend on the type of device and whether it needs to comply with the Active Implantable Medical Device Directive, the Medical Device Directive, or Medical Device Regulation (2017/745). The most detailed information that should be included in a CEP for the Directives is provided in MEDDEV 2.7/1 Rev. 4, Section 7, Definition of the scope of the clinical evaluation (Stage 0). An approach that we have used that has been accepted by Notified Bodies has been to include an Appendix to the CER listing key elements and information that are needed to develop the CER (hence, the planning of it) based on the list of elements in the table in Section 7 of the MEDDEV, tailoring the information to the particular device. This includes an indication of the location of relevant information in the Technical Documentation, e.g., risk management information. The time needed to develop such a plan might be a several hours to a day or so, but should be only a fraction of the time needed to develop the entire CER. This is because the suggested contents of the CEP are relatively straightforward.
In contrast, a CEP needed for a CER under the MDR, in which the elements required are specified in MDR Annex XIV, Section 1(a), could take significantly longer due to the need to address such information as: intended clinical benefits to patients with relevant and specified clinical outcome parameters; methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects; parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and intended purpose(s) of the device; and other information, such as clinical development plan (where relevant). Also, the MDR does not require the CEP to be a separate document, so the decision to make it an Appendix that is integral with the CER or separate will depend on a number of factors related to the particular device, including the length of the CEP. That is, it may be easier to have a separate document than one that is part of the CER.
In any case, the time needed to develop a CEP under the MDR will likely be two or three times longer (or more) than one needed for the Directives, so could take several days.
I hope this helps.
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Maria E Donawa, M.D.
President, Donawa Lifescience Consulting Srl
Rome, Italy
medonawa@donawa.com+39 06 578 2665
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Original Message:
Sent: 07-Aug-2020 13:48
From: Colleen Mullen
Subject: Clinical Evaluation Plan/ MEDDEV 2.7/1 Rev. 4
Dear All,
I was wondering if the group had experience in developing a CEP to ultimately support the CER?
I've developed the latter and have been contacted about creating the former.
Any ballpark as to how much time a CEP takes to create?
Many thanks-
Colleen
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Colleen Mullen
Boston MA
United States
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