Clinical evidence your notified body accepts
A weak evidence argument does not fail quietly. It comes back as a deficiency round, and each round costs months you have already promised to someone.
Clinical Evaluation Navigator is the consulting practice of Dr. Hatem Rabeh, MD, MSc Biomedical Engineering. It writes the CEP, CER, SOTA and PMCF documents you submit under EU MDR 2017/745.
- 60+clinical evaluation reports delivered and accepted
- Notified bodiesworks with them, so files are written the way they are reviewed
- MD + MScclinician and engineer, one person
- EN / FRdrafted and reviewed in both
Devices I work on
- AI software as a medical device
- Spine implants and spinal navigation
- Robotic surgical systems
- Fluorescence imaging
- Embolisation devices
What gets delivered
Each document is written to the requirement it has to satisfy, with every claim traceable to a source a reviewer can check.
Clinical Evaluation Plan (CEP)
Defines the scope, the clinical development stage, the endpoints and the acceptance criteria before any data is analysed. A plan states what will be done, never what was found.
Your acceptance criteria are fixed before the data, so nobody can argue they were fitted to it afterwards.
Clinical Evaluation Report (CER)
Appraises and analyses the clinical evidence against the plan’s criteria, under MDR Annex XIV Part A and MEDDEV 2.7/1 Rev. 4.
Your evidence argument holds together when a reviewer reads it cold.
State of the Art (SOTA)
Establishes what current practice and comparable devices actually achieve, which is what the device’s own performance and safety get measured against.
Your thresholds rest on published evidence instead of a number someone chose.
PMCF plan and report
Post-market clinical follow-up under MDCG 2020-7 and 2020-8: what will be collected, from whom, against which thresholds, and what the data showed.
Your post-market plan answers the questions before they are asked.
Clinical investigation support
Investigation plan, protocol and report support under ISO 14155, including when an investigation can be avoided through equivalence.
You find out early whether equivalence spares you the study.
Deficiency responses
Answers to notified body questions, written so the reviewer can locate the change and close the point without a second round.
The point closes on the first round instead of the third.
Who writes your documents
Dr. Hatem Rabeh is a medical doctor and medical engineer working exclusively on clinical evaluation for medical devices. The clinical judgment and the regulatory drafting come from the same person, which is why the evidence argument in the report holds together.
Manufacturers bring him in for a first CE marking, an MDR renewal, or a notified body deficiency round, and he writes the documents rather than reviewing someone else’s draft.
- Track record
- More than 60 clinical evaluation reports delivered and accepted, and ongoing collaboration with notified bodies
- Qualifications
- MD, MSc Biomedical Engineering
- Based in
- 6 rue Simone Veil, 38170 Seyssinet-Pariset, France. Works with manufacturers across Europe.
- Direct line
- +33 7 69 82 08 14
- Frameworks applied
- EU MDR 2017/745, MEDDEV 2.7/1 Rev. 4, the MDCG 2020 series, ISO 14155, ISO 14971
- Languages
- English and French
What clients say
Published recommendations on LinkedIn, quoted in full context there.
“He helped us assess the strengths and weaknesses of our initial approach, then guided us through the state of the art report, clinical evaluation plan and clinical evaluation report with clear, structured steps.”
“He consistently met deadlines, delivering high-quality results that were instrumental in advancing the development of our medical device.”
“The state-of-the-art report he delivered was clear, detailed, and directly useful for our regulatory and market access strategy.”
“He guided us through key decisions, helping us structure our approach in a way that was clear, well-documented, and aligned with regulatory expectations.”
“Very knowledgeable and always willing to share, with especially an excellent knowledge in clinical evaluation of medical devices.”
How the work runs
The Clinical Evidence Acceptance method. Five steps, the same order every time, so you always know where you are and what lands next.
We look at what you already have
Your device, what it claims to do, and the clinical evidence in your file today. The point is to find the gap now, not three months in.
You get: a written list of what is missing.
We establish what good looks like
What comparable devices on the market actually achieve. This becomes the bar your device is measured against, so it is settled before any target is.
You get: the state of the art report (SOTA).
We agree the pass marks in advance
Which endpoints matter and what counts as passing, written down before any analysis. Nobody can later argue the targets were chosen to fit the result.
You get: the clinical evaluation plan (CEP).
We write the report
The literature and your own data, appraised and analysed against that plan, with every claim traceable to its source.
You get: the clinical evaluation report (CER).
We defend it with your notified body
When questions come back, they get answered so the reviewer can find the change and close the point rather than open another round.
You get: the written responses, and the point closed.
Common questions
What is a clinical evaluation report?
A clinical evaluation report assesses the clinical evidence for a medical device and concludes whether it demonstrates safety, clinical performance and clinical benefit for the intended purpose. It is required under EU MDR 2017/745 Annex XIV Part A.
What is the difference between a clinical evaluation plan and a clinical evaluation report?
The plan is written first and defines the method: the scope, the endpoints, and the acceptance criteria the device will be judged against. The report applies that method and presents the results. A plan that already contains results cannot have been written before the analysis, and a reviewer notices.
Does a Class I device need a clinical evaluation?
Yes. Clinical evaluation is required for every device class under EU MDR 2017/745. The depth of the evidence changes with class and risk, the obligation does not.
What is a state of the art analysis?
It establishes what is currently achievable for the same clinical condition and device type, drawing on published literature and comparable devices. It is what gives the acceptance criteria a defensible basis instead of an arbitrary threshold.
Start with the device, not a proposal
Tell me the device, its class and where you are in the process. You get a straight answer on what is needed and what is missing.
