Writing a Successful Clinical Evaluation Report
As medical device companies work toward complying with the more stringent medical device regulations and guidelines, the role of effective medical writing becomes increasingly important.
Central to being compliant with the new Clinical Evaluation requirements is the development of novel documents, including the Clinical Evaluation Report (CER). The fourth revision of MEDDEV 2.7.1 specifies that the people involved in evaluating the clinical data for this report should be suitably qualified and possess a range of skills stemming from a knowledge of research methodology, clinical investigation design, biostatistics, information management, experience with relevant databases such as Embase and Medline, a degree from higher education in the respective field, and 5 years of documented professional experience.
These are just some of the qualifications an experienced medical writer would have gained by writing various regulatory documents in the strictly legislated biopharmaceutical and Medical Device industries.
The CER has to be submitted with the device´s Technical File as a component of the CE marking and conformity process. It is therefore wise to approach the CER as a standalone document due to its central importance and comprehensive inclusion of all the clinical evidence regarding the medical device´s safety and performance data.
A successful CER clearly presents strong clinical evidence that the medical device performs as intended without putting users and patients at risk. This clinical evidence is to come from three main sources:
- Clinical data from an in-depth methodological review of existing literature and appraisal of the scientific validity of results from the relevant articles
- Reports of clinical experience using the device, and
- Specifically designed clinical trials.
An experienced medical writer will have the relevant skills and experience to gather the various data about the medical device from the respective experts such as the manufacturer, information scientists, quality specialists, and safety scientists, and relevant departments such as regulatory, sales and marketing, research and development, clinical, and risk management. The medical writer would also be able to compile and analyze the data and then draft the CER by presenting the results objectively and according to the stipulations of MEDDEV 2.7.1 (Rev4), Medical Device Regulation (MDR 2017/745) and all other appropriate EU requirements.
The medical writer would therefore be a key member of any CER authorship team and will play a central role in giving the medical device´s regulatory compliance the best chance of success.
Medical Device Regulation: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance.) Available online: Click here to read more (Accessed: 17 September 2019).
MEDDEV 2.7/1 revision 4: European Commission. Clinical Evaluation: Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC. Available as PDF: Click here to read more (Accessed: 17 September 2019).
Documents need to be written | Europital can write them for you
At Europital, our modular approach to lending a helping hand no matter the size of the task, can help you prepare yourCER according to plan, on time, and to budget.
Contact our Senior Medical Writer, to learn more about how we can help you with all your Medical Writing needs.