The clinical evaluation report (CER) is an important part of the Technical File/ Design Dossier for a medical device.
Although the medical writer conducts the literature review and compiles the CER, input is required from several disciplines: engineers, regulatory specialists, safety scientists and quality experts all play vital roles. The aim of this workshop is to better understand what is involved in writing a CER to MDR standards and how the different disciplines can contribute to the CER writing process.
The workshop will focus on the increased requirement for compliant CERs based on the evolution of the MEDDEV documents and the MDR. It will combine analysis of the new regulatory requirements per product risk class with real life examples on do’s and don’ts when planning and writing CERs.
Who is the course for?
This workshop will be of interest to anyone involved with the clinical evaluation process and who contributes to the CER:
- Clinical Department managers
- Regulatory Affairs managers
- Marketing staff
Experience of writing or contributing to a CER and awareness of the MDR 2017/745 would be useful.
Participants should be familiar with MEDDEV 2.7/1 rev. 4 (2016), particularly Appendix A9, as this will be referred to during the workshop.
- Introductions and workshop overview
- Overview of clinical evaluation and clinical investigation requirements of the MDR, MEDDEV 2.7/1 rev4, MEDDEV 2.12/2 rev 2 and ISO 14155
- Brief overview of medical devices classification. Risk class and notified body expectations on clinical data and summary of clinical documents related to each risk class
- Stages of clinical evaluation
• Scoping and planning – the clinical evaluation plan: What is “sufficient clinical data”?
When are clinical studies necessary? When can I claim equivalence?
• Identifying and appraising pertinent data
• Analysis of clinical data
- The CER layout and content, with particular focus on:
• Current knowledge and state of the art
• Equivalence justification
• Clinical literature review
• Risk assessment
• Post-market surveillance (PMS) and post-market clinical follow-up (PMCF)
• Update from ISO 14155
- Discussion of participants’ real life examples
- Summary and Conclusions
Type of training
The workshop will be a mixture of presentation, group work and discussion.
At the end of the training, you will be able to…
…know how to write a CER and what should be included in it.
Gillian is a pharmaceutical physician and regulatory medical writer with over 30 years’ clinical and industry experience providing regulatory writing services for pharmaceutical and medical device clients.
Gillian has broad pharmaceutical and medical devices experience across a wide range of therapeutic areas, e.g. cardiology, orthopaedics, clinical pharmacology, ophthalmology, diabetes and gynaecology. Over the years she has written numerous clinical study reports, clinical evaluation reports, clinical summaries and overviews, and various clinical trial documents. Gillian trained in medicine and was a research physician in academia and phase I-II contract research; a clinical project manager for phase III trials with Pfizer GRD; and also with a pharmaceutical and medical devices consultancy. She is a member of the Royal College of Physicians and Faculty of Pharmaceutical Medicine, has an MBA and an MSc in Clinical Pharmacology. Gillian is an active member of the European Medical Writers Association (EMWA) where she gives workshops on literature reviews, transferable skills in pharmaceutical and medical device writing, drug safety and ICH-GCP. She is a member of EMWA’s medical devices special interest group.