Clinical Evaluation Report is a method to collect, appraise and analyse clinical data (pre- and post-market ) pertaining to a particular medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use.
Clinical evaluation is a responsibility of the legal manufacturer and the annual Clinical Evaluation Report is a part of the technical file of the medical device. Clinical evaluation is conducted throughout the life cycle of a medical device, as an ongoing process.
MEDDEV 2.7/1 revision 4 is the latest guidelines to the manufactures and Notified Bodies for the CE Marking process as per new directives 93/42/EEC and 90/385/EEC.
LMG has a full package service in the quickest time period for developing the following set of documents according to client requirement.
- Risk Management File
- Stages (0, 1, 2, 3 and 4) of Clinical Evaluation Report including CER
- Post Market Surveillance (PMS)
- Post Market Clinical Fallow Up (PMCF)
- IFU/User manual
LMG undertake service request from manufactures of Class IIa, Class IIb and Class III.
The full package fees starts @2200 USD for class IIa, 2800 USD for class IIb, 3200 USD for class III.
Fees may change depends on the variants and models.