Clinical Evaluation of Medical Devices according to MDR (EU) 2017/745
Conformity Assessments of Medical Devices
In the EU, the technical documentation and clinical evaluation form the central part of medical device conformity assessments. A clinical evaluation is required for medical devices of all risk classes and is crucial in determining the need for clinical studies.
With the introduction of the new MDR (EU) 2017/745 and the recent MEDDEV 2.7/1 revision 4, the rules for planning and updating clinical evaluations have been tightened.
In 2020, the guidelines relating to clinical evaluation and the “clinical evaluation assessment report template” of the Medical Device Coordination Group (MDCG) were published. This means that all relevant guidance documents are now available for the preparation of a clinical evaluation in accordance with the MDR. However, the guidelines have now become increasingly complex and confusing, so that a clinical evaluation should definitely be carried out by experts in order to ensure conformity with all requirements.
Literature Research and Clinical Evaluations
Our experts conduct or update scientific literature searches in line with the requirements of the MDR (EU) 2017/745 under consideration of the latest guidelines, which form the basis for a clinical evaluation. In the case of newly developed products, we recommend to conduct a literature search in advance in order to be able to better assess the expected requirements and approval effort.
Our experts first create a clinical evaluation plan ensuring that all of the information we need for the report is available.
In terms of the clinical evaluation report, to provide the required information and evaluations in a targeted manner, we apply the "clinical evaluation assessment report template", which is also used by the notified bodies. Of course, if available, we also take into account the data of technically, biologically and clinically similar products in order to avoid gaps in the proof of suitability for the indications you have defined.
- Equipped with recent and individually customized literature, you can get an idea of your device’s ranking on the global market and the key factors relevant for the medical practice.
- Our expert clinical evaluation helps you to save time and speed up the conformity assessment procedure with your notified body.
- With suitable literature evidence and the professional evaluation of literature data, you can save costs by avoiding unnecessary clinical investigations or PMCF studies.
Feel free to contact us for more information on the procedure of a clinical evaluation or request a call from our expert. We also support you in processing deviations identified by your notified body.