Clinical Data as an Input to Biological Evaluation

A joint session on EU MDR with Dr. Hatem Rabeh (Clinical Evaluation Navigator) and Marina Daineko (MedCore)

Clinical investigation data, equivalence claims, published literature and PMS/PMCF signals are all admissible inputs to biological evaluation. This session shows where clinical data helps and where it stops. Recorded live on 30 October 2026, with the live audience Q&A.

Key Takeaways from This Session

The clinical evaluation chain starts from the state of the art. The workflow runs from the state of the art to the clinical evaluation plan, the acceptance criteria and PMCF. The first part of the session lays it out so the biological evaluation can be read against it.

Biocompatibility is not a bubble. The clinical evaluation outputs that flow into a biological evaluation were set out one by one, so the two documents tell the same story about the same device.

Intended use is the starting point, and the patient population sets limits. The patient population is rarely considered in biological evaluations, yet residual limits differ for neonates, paediatric patients and adults.

Biological equivalence and similar clinically established devices. The session covers biological equivalence in the 2025 edition of ISO 10993-1, predicate devices, and similar clinically established devices.

Clinical use, use history and reasonably foreseeable misuse. A long history of safe use and reasonably foreseeable misuse, which is now part of ISO 10993-1, were discussed as inputs and as limits.

Only complaints that show a biological response count. Complaints and post-market data were sorted into those that matter for biocompatibility and those that do not. An absence of complaints is not proof of safety.

Devices on the market and new devices are handled differently. The clinical evaluation side was explained for both cases, including how the biological evaluation report feeds the manufacturer data section of the CER.

Copy-paste versus summaries, and what auditors see. Copy-paste between the SOTA, the CEP and the CER was compared with short summaries, from the point of view of the person who reads the file.

What We Cover in This Session

● How a clinical evaluation is built: state of the art, the clinical evaluation plan, acceptance criteria and PMCF

● Intended use and patient population, and why they set limits in a biological evaluation

● Biological equivalence: predicate devices and similar clinically established devices

● Clinical use, use history and reasonably foreseeable misuse

● Complaints and post-market data, and which of them count for biocompatibility

● Live Q&A: gaps from the biological evaluation report in the CER

● Live Q&A: IMDRF codes and biocompatibility issues

● Live Q&A: history of safe clinical use in the biological evaluation report

● Live Q&A: safety signals from market feedback

Meet the Speakers

Dr. Hatem Rabeh

MD, MSc Eng. • Clinical Evaluation Expert, Clinical Evaluation Navigator

Dr. Rabeh brings a unique combination of clinical, engineering and regulatory expertise.

Doctor and Biomedical Engineer: A medical doctor who also holds a master’s degree in biomedical engineering, with more than eight years devoted exclusively to the clinical evaluation of medical devices under EU MDR.

Both Sides of the File: More than 60 clinical evaluation reports written and reviewed across Class I, IIa, IIb and III devices, prepared for manufacturers and assessed from the notified body side.

Speaker and Author: Speaker at the European Medical Writers Association and the CSMD-Horizon congress, co-host of a state of the art webinar with the notified body Szutest (NB 2975), and publishing weekly on clinical evaluation on LinkedIn.

Dr. Rabeh on LinkedIn →

Marina Daineko

MSc • Biocompatibility Consultant, MedCore

Marina is a biocompatibility consultant who speaks and trains on biological safety and evaluation. In this session she covers the biological evaluation side: what clinical data can support, and where its limits are.

Marina on LinkedIn →
MedCore →

Who Should Watch This Session?

This session is for anyone who writes or reviews a biological evaluation or a clinical evaluation, and needs the two to agree:

✓ Biocompatibility and toxicology specialists who want to know which clinical data they can use
✓ Clinical Evaluation Specialists and Medical Writers who receive a biological evaluation report for the CER
✓ Regulatory Affairs Managers preparing a submission or answering a deficiency round
✓ Quality and PMS Managers deciding which complaints and post-market data feed biocompatibility

Also Watch: More Notified Body Webinars

Earlier sessions: a notified body clinical reviewer on what he looks for in a clinical evaluation, and three with SZUTEST NB2975: how notified bodies interpret the state of the art during review, what counts as clinical data under the MDR, and how to CE mark AI software under the MDR and the AI Act.

Watch the Notified Body Reviewer Webinar →
Watch the SOTA Webinar →
Watch the Clinical Data Webinar →
Watch the AI Software Webinar →

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Educational and general information. Nothing said in this session is a decision, an approval, or regulatory, legal or medical advice, and nothing binds any notified body or authority.

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