Regulatory Strategy / Clinical Evaluation of Medical Devices

Are you a medical device manufacturer ?


RCTs will support you in defining the regulatory strategy for your device as well as in conducting its clinical evaluation :


Regulatory strategy
Faced with the challenges related to European Regulation 2017/745, our experts specialized in medical devices will help you :
– Define and justify the class and status of your medical device
– Establish a regulatory development plan, detailing all the activities to be carried out to obtain the CE-marking
We will assess the specificities of your medical device and will guide you throughout the compliance with Regulation 2017/745.
Clinical Evaluation (CEP and CER)
The clinical evaluation involves the collection, analysis, and evaluation of the clinical data of a medical device (from clinical investigations, literature and/or post-market surveillance) in order to demonstrate the clinical safety, performance, and benefits of the device. The clinical evaluation is to be carried out throughout the life cycle of your device and needs to be submitted to your Notified Body to obtain, then renew, the CE-marking of your device. Depending on your needs, RCTs will :
– Create or update your Clinical Evaluation Plans and Reports (CEP and CER) in line with Regulation 2017/745 and the MDCG guidelines.
– Support you on a specific part of the clinical evaluation (e.g., definition of keywords, bibliographic research, medical device vigilance research, etc.)
At the early stages of development of your device, an initial clinical evaluation can be carried out for internal purposes. As it mainly consists of a literature review, this evaluation will enable you to better understand the medical field and alternative therapies of your device and, thus to :
– Refine the indications and clinical claims of your device
– Write its Instructions For Use (IFU)
– Define the clinical evaluation strategy
– Determine whether clinical investigations need to be carried out
– Guide you on the design of these investigations.

Our experts are available for you

Morgane Champiot
Study Director - Member of the AFCROs MD working group
Sara Guillemin
Medical Writer & Medical Device Regulatory Consultant at RCTs

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