If you would like to sell your medical devices in Europe, you must conduct a Clinical Evaluation in compliance with MDR 2017/745!
Clinical Evaluation, as per the MDR and MEDDEV 2.7/1 Rev.4, is a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertained to medical device in order to verify the safety and performance, including clinical benefits, of the medical device when used as intended by the manufacturer.
The results of your Clinical Evaluation will be recorded in the Clinical Evaluation Report and associated documents, which is an important phase in the way to the CE marking.
Clinical evaluation demands that the manufacturer must demonstrate the clinical benefits of their medical device to a sufficient degree. The manufacturer must ensure that unacceptable risks or side-effects will not be caused by their medical devices. They must also demonstrate that any claims made by the manufacturer about the safety and performance of the medical device needs to be supported by suitable evidence.
Clinical Evaluation takes place in 5 stages as per MEDDEV 2.7/1 Rev.4:
Stage 0: Define the scope and planning of clinical evaluation
Stage 1: Identification of the Pertinent Data
Stage 2: Appraisal of the individual data set in terms of scientific validity, relevance and weighting
Stage 3: Analysis of the clinical data
Stage 4: Finalize the Clinical Evaluation Report
Clinical Evaluation Report
The results of your clinical evaluation are documented in the Clinical Evaluation Report [CER]. It should demonstrate that the medical devices are clinically safe and efficient with respect to the intended purpose of the medical device. CER is required for all medical devices in Europe and it should be attached with the Technical file while submitting to the notified body.
Some of the contents of a CER are:
- Summary
- Clinical background, current knowledge and state of the art
- Clinical Data generated and held by the manufacturer
- Clinical Data from Literature
- Summary and appraisal of clinical data
- Analysis of the clinical data (Requirement on Safety, Requirement on acceptable Risk/Benefit Profile, Requirement on performance, Requirement on acceptability on side-effects)
- Conclusions
The CERs should be regularly updated based on the inputs from Post the Market Surveillance and Vigilance activities. Failure to do so would endanger the conformity with the medical device regulations.
Advantages of Outsourcing Clinical Evaluation
- Our experts will simplify and organize the clinical evaluation documentation without any delay;
- We have trained professionals who can document the Clinical Evaluation results without much hassle as they have deep insights into the matter due to their experience;
- Experts in reviewing medical device clinical data;
- Much economical than an in-house team at your firm;
- We have a large reference to standards and document collection;
- Good reputation and rapport with all Notified Bodies.
As per the MDR, clinical evaluation is a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertained to medical device in order to verify the safety and performance, including clinical benefits, of the medical device when used as intended by the manufacturer
- Clinical data is the information concerning safety or performance that is generated from the clinical use of a medical device and is sourced from the following:-clinical investigation(s) of the device concerned,-clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the medical device in question can be demonstrated,-reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a medical device for which equivalence to the medical device in question can be demonstrated,-clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up.
Clinical Evidence is the clinical data and clinical evaluation results associated to a medical device of a sufficient amount and quality to allow a qualified assessment of whether the medical device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer.
Clinical Evidence is the clinical data and clinical evaluation results associated to a medical device of a sufficient amount and quality to allow a qualified assessment of whether the medical device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer.
It is a systematic study in one or more human subjects, undertaken to assess the safety and performance of a medical device.
It is the practice of monitoring the safety and performance of a medical device after it has been released to the market. It is a mandatory regulatory requirement in EU and USA. The purpose of PMS is to identify any need to immediately apply any necessary Corrective actions or Preventive Actions.
Stage 0: Define the scope and planning of clinical evaluation
Stage 1: Identification of the Pertinent Data
Stage 2: Appraisal of the individual data set in terms of scientific validity, relevance and weighting
Stage 3: Analysis of the clinical data
Stage 4: Finalize the Clinical Evaluation Report
PMCF is a study carried out following the CE marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a medical device when used in accordance with its approved labelling.
Clinical Evaluation Plan determines the practicability of clinical evaluation by means of literature research and provides a road map for the clinical evaluation itself.
The contents of a CER are:
- Summary
- Scope of the clinical evaluation
- Clinical background, current knowledge and state of the art
- Device under evaluation
- Type of evaluation
- Demonstration of equivalence
- Clinical Data generated and held by the manufacturer
- Clinical Data from Literature
- Summary and appraisal of clinical data
- Analysis of the clinical data (Requirement on Safety, Requirement on acceptable Risk/Benefit Profile, Requirement on performance, Requirement on acceptability on side-effects)
- Conclusions
- Date of next clinical evaluation
- Dates and signatures
- Qualification of the Evaluators