Clinical evaluation of a medical device, which means making, collecting, analysing, and evaluating clinical data about your device on a regular basis, is a key part of getting and keeping EU market approval.
For medical device clinical evaluation to be approved and developed, it needs to meet strict regulatory guidelines (MEDDEV 2.7/1 version 4 and MDR 2017/745). This means that it needs to have regulatory documents that show credible clinical evidence of how safe and well it works.
What is Clinical Evaluation (CE)?
A clinical evaluation is the analysis and collection of clinical data from different sources in a planned way.
The MDR says that the maker of a medical device has to do a clinical evaluation during the whole time it is in use. So, a clinical evaluation also includes a clinical follow-up of the medical device on the market. The clinical evaluation has to be a part of the quality management system, and it has a lot to do with the risk management that has to be done.
Aim of Clinical Evaluation
The goal is always to confirm the clinical safety and efficacy of the medical device throughout its expected lifecycle and to make sure that the risks that have been found are worth it compared to the clinical benefit.
Clinical evaluation is hard to do and takes a lot of time, so it may only be possible for an interdisciplinary team to handle it. Hire our experts to handle parts of the process or the whole thing, and we’ll make sure you can focus on what you do best while we take care of the rest. Furthermore, it provides suitable strategies which help keep your documents up to date in the future with personal efforts and little time.
Steps in Clinical Evaluation
Let’s talk about the basics of how your device will be evaluated in a clinical setting.
The guidelines say that during a clinical evaluation, the following steps should be taken:
Step 0: Planning
Outline the structure and goal of the clinical evaluation, the type of product development (known or new application, new technology, and intended use), and how the product will be used.
Step 1: Identification
Consider the possible sources and equivalence, and collect clinical data: clinical experience, scientific literature, and clinical trial.
Step 2: Assessment
Each person looks at their own data and compares it to set criteria. (Is the source safe? Does the source tell you about the product’s safety and benefits?)
Step 3: Analysis
Overall evaluation of relevant data to see if there is proof of how well and safely a medical device works. Criteria: Importance of data, conclusions about the safety and benefits of the product, and the ability to evaluate in either a quantitative or qualitative way.
Step 4: Report
Report on the evaluation that is logically organised, with documentation and justifications of the steps and documentation of each step (Clinical Evaluation Report).
Documentation For Clinical Evaluation
A clearly and well-designed written are required for all device classifications, including both old and new devices, in order to record and plan the medical device clinical evaluation and evidence.
As part of the Technical Documentation, the CER and CEP are two important documents that the Notified Body, which is an independent organisation accredited by a European Member State and responsible for assessing conformity and (re-)certifying most medical devices and in-vitro diagnostics so that they can be sold on the European market, looks over.
To get and keep a CE mark, you need to go through a medical device clinical evaluation. Setting up the clinical strategy early on in the development process makes sure that clinical evidence about your device will be collected.