EU Clinical Evaluation Reports (CER) and Literature Review for Medical Devices
European Directive 2007/47/EC, which amends the EU Medical Devices Directive MDD 93/42/EEC (and Active Implantable Medical Devices Directive AIMDD 90/385/EEC), places greater emphasis on clinical data and a Clinical Evaluation Report (CER).
Recital 8, which is in the preamble of Directive 2007/47/EC, makes the statement “clinical data, even for Class I devices, is generally required”.
Also, Annex I, Essential Requirements states: “Demonstration of conformity with the Essential Requirements must include a clinical evaluation in accordance with Annex X”.
Can we assist you with the medical device Clinical Evaluation Report (CER) or Clinical Literature Review?
Clinical evaluation entails the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device. Based on our medical clinical professional background we're specialized in reviewing medical clinical data, including medical devices, and we can ensure that your Clinical Evaluation Report meets all EU requirements.
We assist you by preparing the entire Clinical Evaluation Report, the Clinical Literature Evaluation section of the CER and or we provide your team with a search strategy protocol and list of references in support of your CER.
Please contact us on how we assist you with preparing your clinical evaluation reports and performing clinical literature reviews.
Clinical Evaluation in the MDR
The Medical Device Regulation (MDR) aims to elaborate on the current clinical investigation requirements in Article 15 MDD and Annex X, and aligns the MDR with the clinical trials regime for medicinal products. The system proposed for clinical investigations is similar to the current system for medicinal products under the Clinical Trials Directive (Directive 2001/20/EC), including notification in a centralized database as is currently the case in EudraCT, the European Clinical Trials Database.
ISO 14155:2011 addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out on human subjects to assess the safety or performance of medical devices for regulatory purposes. ISO 14155:2011 does not apply to in vitro diagnostic medical devices (IVDR).
The ISO 14155 standard contains extensive guidance on the most important processes of clinical investigations with medical devices. It references the ISO 14971 standard on the application of risk management to medical devices, which means these two standards need to be understand and executed together.
Our team of professionals includes medical specialists, MD's, professors, scientists, research nurses, etc., who are looking forward to support your endeavors.
We offer you services to that include
- a submission process for multinational clinical investigations in the EU that must be performed via an electronic system.
- communication with local Ethical Committees
- patient information process (see amended annex XIV, part I and II).
- Post-Market Clinical Follow-up (PMCF) and implementing the PMCF MEDDEV 2.12/2 Rev2.
- medical writing
- monitoring activities
- covering clinical trial liability insurance (mandatory)