Pre-clinical Investigation, Clinical Investigation and Clinical Evaluation
The outcome of pre-clinical investigations can be used to get early customer feedback on products. This feedback can be used to improve your product design, to define your marketing strategy and your product positioning. Furthermore, a properly design clinical study should support the marketing strategy and help Research and Development for the creation of next generation product. In conclusion, pre-clinical and clinical investigations with added R/D and marketing value can help you to develop and introduce to the market a superior product in a timely manner.
To ensure a successful development and launch of your new or modified products, VISAMED offers you the possibility to evaluate your products using in vitro and in vivo models. VISAMED can help you in designing and performing bench test and acute and/or chronic animal studies. Those studies can serve as product design verification and validation. As a result, those studies will support the General Safety and Performance Requirements (Medical Devices Regulation (MDR) (EU 2017/745, Annex I) and global regulatory filing. VISAMED provides the following services:
- Identify standards/guidelines and requirements for in vitro and in vivo testing
- Develop product testing strategy in compliance with identified requirements
- Design, coordinate and/or perform testing
VISAMED can help you to manage your clinical study by assisting you with:
- the selection of the appropriate clinical strategy
- the selection of suitable investigators
- the Design of clinical plans and conformity with the European harmonized standards EN ISO 14155 series
- the Insurance coverage
- the Applications/Notification to Ethical committees and European competent authorities
- the Study initiation and monitoring
- the Data management and analysis
EU MDR Compliant Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER)
VISAMED is preparing clinical evaluations for your products compliant to EU MDR. The evaluation of clinical data is not only of prime importance for the official approval process and product launch, but also for the continuing market surveillance in the field of medical devices.
The clinical evaluation is based on a comprehensive analysis of available pre-and post market clinical data relevant to the intended use of the device in question, including clinical performance data and safety data. This includes data specific to the device in question as well as any data relating to devices claimed as equivalent by the manufacturer. The outcome of this process is a report which includes a conclusion on the acceptability of risks and side effects when weighed against the intended benefits of the device.
The evaluation of clinical data is part of the technical documentation and conformity assessment, and therefore has to be submitted to the notified body as part of the official approval process for medical devices. The clinical evaluation should be revised in regular intervals based on the risk of the product.
Update your CER with Clinical Data from post Market Surveillance (PMS) and Post Market Clinical Follow-Up (PMCF). The 4th revision of the MEDDEV 2.7.1 Clinical Evaluation states that:
- All Device Classifications need a Clinical Evaluation Plan and Report
- Manufacturers must define and justify the frequency of updating their CER’s
- CER’s need to be updated with new PMS data when there is a change in the current evaluation.
Other relevant guidance documents are: MDR (2017/745), MDCG 2020–1, MDCG 2020–5, MDCG 2020–6, MDCG 2020–13 and IMDRF MDCE WG/N56.