Clinical Evaluation Report
Clinical Evaluation Report is a report that must be prepared regardless of the risk group of the device. Clinical Evaluation Report must demonstrate that the medical device has the safety and performance properties at the same level as the applicable directives, standards, guides etc. set forth and as the equivalent and reference device have. In the preparation of Clinical Evaluation Report different clinical and non-clinical data are utilized. The data that will be used in the Clinical Evaluation Report must be correctly chosen, evaluated with attention and approved by the professional team.
Clinical Evaluation Report must be reviewed and updated periodically. Advice on how frequently it should be reviewed is written in Meddev 2.7/1 guide. Clinical evaluation report which is the most critical section of the technical file of a device, must be prepared by a person who has knowledge on the production and applicable standards, directives and guides, and also experience on clinical evaluation. Clinical Evaluation Report Consulting is important because:
- Clinical Evaluation Report Consulting plays an effective role in deciding which data should be used in the clinical evaluation report and where should this data be gathered from.
- Clinical Evaluation Report Consulting also plays an important role in determining the evaluation criteria.
- Clinical Evaluation Report Consulting provides solutions on how frequently you should review the clinical evaluations.
TıbbiCE Consulting, Training and Validation Services’ principle for product and quality management system is to give a “Purpose-driven, Solution and Customer Satisfaction Oriented” service that grounds on data confidentiality with its expert consultants.
We share the knowledge and experience we have gained in 9 years through working with more than 140 medical device producers and being involved in the CE and ISO 13485 Certification processes of more than 300 medical devices. We conduct the certification process professionally and aim to complete it in optimum time.
- General Overview of Clinical Evaluation
- What is a Clinical Evaluation?
- When is clinical evaluation undertaken and why is it important?
- Clinical evaluation for initial CE-marking
- How Frequently Should the Clinical Evaluation be Updated?
- PMS, POST MARKET SURVEILLANCE, PMCF, POST MARKET CLINICAL FOLLOW UP
General Overview of Clinical Evaluation
Clinical Evaluation (Meddev 2.7. rev.04 Guide) INTRODUCTION
- section 6a of Annex I to Directive 93/42/EEC (amended by Directive 2007/47/EC) and to
- section 5a of Annex 1 to Directive 90/385/EEC (amended by Directive 2007/47/EC),
the demonstration of conformity with Essential Requirements for a medical device must include a clinical evaluation, which is conducted in accordance with Annex X to Directive 93/42/EEC or with Annex 7 to Directive 90/385/EEC.
Clinical Evaluation (meddev 2.7.1.rev.04 Guide) SCOPE
It provides a general approach for MDD and AIMDD, cannot be used for IVD.
The depth and the scope of the clinical evaluation must be appropriate to the nature, intended purpose and the risks of the investigated device.
MEDDEV 2.7.1 guide is not legally binding. It is recognized that under given circumstances, for example as a result of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements.
Nevertheless, due to the participation of interested parties and of experts from national Competent Authorities, it is anticipated that this guide will be followed within the Member States, thereby supporting uniform application of relevant provisions of EU Directives and common practices.
On certain issues not addressed in the Directives, national legislation may be different from this guide.
This guide is regularly updated according to regulatory developments. The latest version of the guide should always be used.
Clinical Evaluation (Meddev 2.7.1rev.04 Guide) DEFINITIONS
Adverse event: any untoward medical occurrence, unintended disease or injury, or any untoward clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or not related to the investigational medical device.
Serious adverse event: adverse event that led to death or led to serious deterioration in the health of the subject.
Clinical data: Clinical data are sourced from:
- clinical investigation(s) of the device concerned; or
- clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or
- published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.
Clinical evaluation: a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a 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 evidence: the clinical data and the clinical evaluation report pertaining to a medical device.
Clinical investigation: systematic investigation in one or more human subjects, undertaken to assess the safety or performance of a medical device. Note: 'clinical trial' or ' clinical study' are synonymous with ' clinical investigation'.
Clinical investigation plan: document that states the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical investigation.
Clinical performance: behaviour of a medical device or response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s).
Clinical safety: freedom from unacceptable clinical risks, when using the device according to the manufacturer’s Instructions for Use.
Clinical use: use of a medical device in or on living human subjects.
Equivalent device: a device for which equivalence to the device in question can be demonstrated.
Harmonised standards: standards whose references have been published in the Official Journal of the European Communities.
Hazard: potential source of harm.
Hazard due to substances and technologies: for the purpose of this MEDDEV document, a hazard that is seen with products that share specific characteristics.
Incident: any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health.
Information materials supplied by the manufacturer: for the purpose of this document, this refers to the labelling, instructions for use and the manufacturer's promotional materials for the device under evaluation.
PMCF study: 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 device when used in accordance with its approved labelling.
PMCF plan: the documented, proactive, organised methods and procedures set up by the manufacturer to collect clinical data based on the use of a CE-marked device corresponding to a particular design dossier or on the use of a group of medical devices belonging to the same subcategory or generic device group as defined in Directive 93/42/EEC.
Risk: combination of the probability of occurrence of harm and the severity of that harm.
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