How To Write An Effective CER
The clock is ticking for medical device manufacturers distributing in the European Union (EU). The EU is transitioning from the Medical Device Directive (MDD) to the new Medical Device Regulation (MDR). The updated European Medical Device Regulation (MDR) introduced in May 2017 has new, stricter criteria for CER (Clinical Evaluation) reports, such as the basis of establishing an equivalence with another device and the quality of data considered in your clinical evaluation.
We consider the 5 issues that you should consider when creating a Clinical Evaluation Report.
1. Define a CER protocol and strategy
Identify the scope of the medical device and the Clinical Evaluation Report and create a plan for the clinical evaluation (performance, safety, and risk/benefit endpoints).
2. Demonstrate equivalence in Clinical Evaluation Reports
Among the most complex aspects is the term ‘equivalence’, which – if demonstrated – would exempt manufacturers of high-risk devices from performing costly and lengthy clinical investigations. This section must address whether the clinical evaluation is based on scientific literature and justify equivalence if clinical data is not appropriate for the device. It is critical to avoid the common mistake of selecting equivalent devices that are not relevant to your product. Documented data must be identified and analyzed for each equivalent device and for the differences between devices.
3. Evaluate literature review data
It is critical that literature surveys are conducted in a systematic process. The clinical context should be heavily detailed and address: 1) Sources, 2) Search methods (including selection criteria for the literature review), 3) Quality control measures, 4) Results, 5) Number and type of research literature. The data analysis should include an objective method (multiple reviewers)
4. Determine the requirement for clinical investigation
The requirement for a clinical investigation is determined by the risk profile of the device. High-risk devices and devices based on innovative technologies (or for a new intended use) must be subject to a clinical investigation.
5. Monitor post-marketing activities
Under the MDR, PMS activities must be adequately planned and documented in the CER. The processes for evaluating ongoing clinical data and updating CERs must also be documented.
Talk To Us About Clinical Evaluation Reports
Acorn Regulatory is unique in that we employ a full-time staff of experts across many disciplines including clinical and device. We have extensive experience of writing clinical evaluation reports for client companies. Talk to us today to see how we can help you with issues related to clinical evaluation reports.
Call us on 00353 52 61 76 706 or complete the form below.
Further MDR Reading from Acorn Regulatory
The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR
As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at the role of the Person Responsible for Regulatory Compliance (PRRC).
The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European medical devices legislation that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices. Read more here.
Get The 1st Acorn Regulatory Medical Device Regulations Whitepaper
The new medical device regulations (MDR) will come into force in May 2020. In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations. For many companies, there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied. Read the first whitepaper here
2nd Acorn Regulatory MDR Whitepaper
The Medical Device Regulations – MDR – What You Need To Know
The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. Our medical device team has been working with many companies to support them for the changeover from the MDD to MDR. During our interactions with these clients, many topics are being raised time and again. Read more here.