Inhaltsübersicht

Inhaltsübersicht

1. Introduction
2. Scope
3. References
4. Definitions
5. Abbreviations
6. General principles of clinical evaluation
6.1 What is clinical evaluation?
6.2. When is clinical evaluation undertaken and why is it important?
6.3 How is a clinical evaluation performed?
6.4 Who should perform the clinical evaluation?
7. Definition of the scope of the clinical evaluation (Stage 0)
8. Identification of pertinent data (Stage 1)
8.1 Data generated and held by the manufacturer
8.2 Data retrieved from literature
9. Appraisal of pertinent data (Stage 2)
9.1 General considerations
9.2 The appraisal plan
9.3 Conduct of the appraisal
10. Analysis of the clinical data (Stage 3)
10.1 General considerations
10.2 Specific considerations
10.3 Where demonstration of conformity based on clinical data is not deemed appropriate
11. The clinical evaluation report (CER, Stage 4)
12. The role of the notified body in the assessment of clinical evaluation reports

Anhänge

A1 Demonstration of equivalence
A2 When should additional clinical investigations be carried out?
A3 Device description – typical contents
A4 Sources of literature
A5 Literature search and literature review protocol, key elements
A5.1 Background to the literature search and the literature review
A5.2 Objective
A5.3 Methods
A6 Appraisal of clinical data – examples of studies that lack scientific validity for demonstration of adequate clinical performance and/or clinical safety
A7 Analysis of the clinical data – compliance to specific Essential Requirements
A7.1 Conformity assessment with requirement on safety (MDD ER1 / AIMDD ER1)
A7.2 Conformity Conformity assessment with requirement on acceptable benefit/risk profile (MDD ER1 / AIMDD ER1)
A7.3 Conformity assessment with requirement on performance (MDD ER3 / AIMDD ER2)
A7.4 Conformity assessment with requirement on acceptability of undesirable side-effects (MDD ER6 / AIMDD ER5)
A8 Devices for unmet medical needs – aspects to consider
A9 Clinical evaluation report – proposed table of contents, examples of contents
A10 Proposed checklist for the release of the clinical evaluation report
A11 Information on declarations of interests
A12 Activities of notified bodies
A12.1 Notified body assessment of clinical evaluation by conformity assessment route
A12.2 Examination of a design dossier (Annex II.4; Annex 2.4) or of a type examination dossier (Annex III; Annex 3)
A12.3 Evaluation as part of quality system related procedures
A12.4 Notified body specific procedures and expertise

4. 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.

NOTE 1: This includes events related to the investigational device or the comparator. NOTE 2: This includes events related to the procedures involved.

NOTE 3: For users or other persons this is restricted to events related to the investigational medical device.

[EN ISO 14155:2011]

Bias: bias is a systematic deviation of an outcome measure from its true value, leading to either an overestimation or underestimation of a treatment’s effect. It can originate from, for example, the way patients are allocated to treatment, the way treatment outcomes are measured and interpreted, and the way data are recorded and reported. [Adapted from GHTF SG5/N2R8:2007]

Clinical data: the safety and/or performance information that is generated from the clinical use of a device. 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.

[derived from Article 1.2.k MDD and Art. 1.2.k AIMDD]

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.

Note: In exceptional cases where an instruction for use is not required, the collection, analysis and assessment are conducted taking into account generally recognised modalities of use.

Clinical evidence: the clinical data and the clinical evaluation report pertaining to a medical device. [GHTF SG5/N2R8:2007]

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’. [EN ISO 14155:2011]

Clinical investigation plan: document that states the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical investigation. [EN ISO 14155:2011]

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). [EN ISO 14155:2011]

Device registry: an organised system that uses observational study methods to collect defined clinical data under normal conditions of use relating to one or more devices to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure and that serves predetermined scientific, clinical or policy purpose(s).

Note: The term “device registry” should not be confused with the concept of device registration and listing.[MEDDEV 2.12/2 rev2]

Clinical safety: freedom from unacceptable clinical risks, when using the device according to the manufacturer’s Instructions for Use. [MEDDEV 2.7/2 revision 2]

Note: In exceptional cases where an instruction for use is not required, the collection, analysis and assessment are conducted taking into account generally recognised modalities of use.

Clinical use: use of a medical device in or on living human subjects.

Note: Includes use of a medical device that does not have direct patient contact.

Equivalent device: a device for which equivalence to the device in question can be demonstrated. [Derived from Art. 1.2.k MDD]

Feasibility study: a clinical investigation that is commonly used to capture preliminary information on a medical device (at an early stage of product design) to adequately plan further steps of device development, including needs for design modifications or parameters for a pivotal study. [MEDDEV 2.7/2 revision 2]

Harmonised standards: standards whose references have been published in the Official Journal of the European Communities. [Derived from article 5 of Directive 90/385/EEC and article 5 of Directive 93/42/EEC]

Hazard: potential source of harm. [EN ISO 14971:2012]

Hazard due to substances and technologies: for the purpose of this MEDDEV document, a hazard that is seen with products that share specific characteristics. Note: This includes products that contain the same materials and substances, material combinations, use the same technologies, produce similar abrasion, are used with the same type of surgical approach, share the same manufacturing procedures or impurities, or share other 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. [MEDDEV 2.12/rev 8]

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.

[Derived from MDD Art. 1.2.g, MDD Annex I section 13, AIMDD Art. 1.2.f, AIMDD Annex I sections 14 and 15]

Intended purpose: the use for which the device is intended according to the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials. [MDD Art. 1.2.g, AIMDD Art. 1.2.f]

Investigator: individual member of the investigation site team designated and supervised by the principal investigator at an investigation site to perform critical clinical-investigation-related procedures or to make important clinical investigation-related decisions. [EN ISO 14155:2011]

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. The objective is to confirm clinical performance and safety throughout the expected lifetime of the medical device, the acceptability of identified risks and to detect emerging risks on the basis of factual evidence. [MEDDEV 2.12/2 rev.2]

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. [MEDDEV 2.12/2 rev.2]

Risk: combination of the probability of occurrence of harm and the severity of that harm. [EN ISO 14971:2012]

Risk management: systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk. [EN ISO 14971:2012]

Serious adverse event: adverse event that

  1. led to death,
  2. led to serious deterioration in the health of the subject, that either resulted in
    1. a life-threatening illness or injury, or
    2. a permanent impairment of a body structure or a body function, or
    3. in-patient or prolonged hospitalization, or
    4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
  3. led to foetal distress, foetal death or a congenital abnormality or birth

NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the CIP [Clinical Investigation Plan], without serious deterioration in health, is not considered a serious adverse event. [EN ISO 14155:2011]

Sufficient clinical evidence: an amount and quality of clinical evidence to guarantee the scientific validity of the conclusions.

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