LNE/G-MED North America, Inc MEDDEV 2.7.1 Rev 4: Implementing New - - PowerPoint PPT Presentation

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contact@lne-america.com 1-301-495-0477 lne-america.com LNE/G-MED North America, Inc MEDDEV 2.7.1 Rev 4: Implementing New Requirements for Clinical Evaluation Reports (CER) 1/25/2017 Do not distribute or reproduce without

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LNE/G-MED North America, Inc

MEDDEV 2.7.1 Rev 4: Implementing New Requirements for Clinical Evaluation Reports (CER)

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Speaker

Anne Le Rouzo

  • Sr Lead Auditor ISO 13485, ISO 9001,

CMDR, MDD, AO regulations, MDD

  • Non active implantable MD specialist

at G-MED NA

  • Technical Documentation and Design

Dossier assessor LNE / G-MED North America, Inc.

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MEDDEV 2.7.1 rev 4

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The new developments of MEDDEV 2.7.1 rev 4

  • New Concept introduced:

 sufficient clinical evidence A Quantity and Quality of the clinical evidence guaranteeing the scientific validity of the conclusions

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The new developments of MEDDEV 2.7.1 rev 4

When is clinical evaluation undertaken?

  • Clinical evaluation is conducted throughout the life cycle
  • f a medical device, as an ongoing process.
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The new developments of MEDDEV 2.7.1 rev 4

Who conducts the clinical evaluation?

The clinical evaluation should be conducted by a suitably qualified individual

  • r a team, taking into consideration:
  • Definition of the requirements in terms of qualification in line with the

device and its clinical performance and risks

  • Justification of choice of the evaluator(s)
  • Declaration of interest of each evaluator
  • Technical and scientific knowledge,
  • Research methodology, information management, regulatory

requirements, and medical writing knowledge

  • Training and experience
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The new developments of MEDDEV 2.7.1 rev 4

How is the clinical evaluation performed?

 Definition of the performance data and clinical safety data of the device  5 stages from the scoping and clinical evaluation plan to finalization of the CER

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Stage 0 Scoping & clinical evaluation plan Stage 1 Identification of pertinent data Stage 2 Appraisal of pertinent data Stage 3 Analysis of clinical data Stage 4 Clinical Evaluation Report

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Stage 0: Definition of the scope of the clinical evaluation & Clinical evaluation plan

 Detailed device description  Appendix A3

  • Identification of the devices (models, sizes, software versions,

accessories

  • Concise physical and chemical description (materials, incorporated

medicinal substances, tissues, or blood products), Mechanical and physicochemical characteristics;

  • Technologies used
  • Description of innovative aspects of the device
  • Place of the device in regards to available treatment /

management/ diagnostic options.

  • Exact description of intended purpose, medical indications
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Stage 0: Definition of the scope of the clinical evaluation & Clinical evaluation plan

 Setting up the clinical evaluation plan: aspects of the plan depending on the stage in the lifecycle of the product: before CE marking vs. CE marked

  • Device description
  • Information needed for evaluation of equivalence (pre-CE)
  • Risk management
  • Current knowledge/ state of the art in the corresponding medical

field

  • Data sources
  • Changes(post-CE)
  • New emerging clinical concerns , PMS aspects (post-CE)
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Stage 1: Identification of the pertinent data

 Data generated and held by the manufacturer:

  • Pre-market clinical investigations
  • All clinical data generated from RM activities and the PMS programs
  • Pre-clinical data

 Data from the litterature:

  • Clinical data relevant to the device under evaluation (data relating to

either the device itself or to equivalent device)

  • Current knowledge/state of the art
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Stage 2: Appraisal of pertinent data  Evaluation of data including scientific validity, relevance and their contribution to the demonstration of conformity

– Quality of the methodology & Scientific Validity of the content (9.3.1) – Relevance of the data (9.3.2) – Weight contribution of each data

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Clinical Equivalence

Revision 3

  • Same intended use and clinical conditions
  • Same site in the body
  • Similar population (including age, anatomy, physiology)
  • Similar relevant critical performance according to the clinical effect

expected for a specific intended use

  • Same clinical conditions and same intended purpose
  • Same site in the body
  • Similar population (including age, gender, anatomy, physiology)
  • Not foreseen to deliver significantly different performances

Revision 4

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Technical Equivalence

Revision 3

  • Used under similar conditions of use
  • Have similar specifications and properties (i.e. tensile strength, viscosity,

surface characteristics…)

  • Be of similar design
  • Use similar deployment methods (if applicable)
  • Have similar principles of operations
  • Used under the same conditions of use
  • Have similar specifications and properties (i.e. tensile strength, viscosity,

intensity of energy, wavelength, porosity, surface texture…)

  • Use similar deployment methods (if applicable)
  • Have similar principles of operation and critical performance requirements

Revision 4

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Biological Equivalence

Revision 3

  • Use same materials in contact with the same human tissues or body fluids
  • Use the same materials or substances in contact with the same human

tissues or body fluids Exception: devices in contact with intact skin and minor components of devices.

Revision 4

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Assuming Equivalence

 Equivalence can only be based on a single device  The three characteristics (clinical, technical, biological) must be fulfilled for this same device  “Similar” means that no clinically significant differences on the performance and safety of the device would be triggered by the differences between the device currently under assessment and the device presented as being equivalent

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Assuming Equivalence

 All differences to be identified, fully disclosed, and assessed  Comparative engineering drawings or pictures must be presented to be able to compare the design (shape) and the sizes of components in contact with the body  The manufacturer must verify whether the presumed equivalent medical device has been manufactured using a special treatment (e.g. surface modification, a process that changes the characteristics of the material); if this is the case, the treatment could cause differences in the technical and biological characteristics; this should be taken into account for the demonstration of equivalence and documented in the CER

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Assuming Equivalence

 Comparative plans or images should be included to compare the shapes and sizes of the elements in contact with the body  The manufacturer should include the non-clinical information (e.g. pre-clinical testing reports) in the technical documentation and summarize the information in the CER (with pointer to relevant sections of the technical documentation)  For the evaluation of technical characteristics, devices that achieve the same therapeutic result by a different means cannot be considered equivalent

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Assuming Equivalence

 For the evaluation of the biological characteristics:

– when a detailed chemical characterization of the materials that are in contact with the body is necessary, then ISO 10993-18 Appendix C can be used to show the toxicological equivalence, but this is just part of the evaluation of the biological criteria; – sourcing and manufacturing procedures may adversely affect impurity profiles  repetition of testing when production methods or sourcing are changed; – it may be necessary to show histopathological studies to demonstrate that the same host response is obtained in vivo for the application and the planned duration of contact; – for the tests on animals, the differences between species can reduce the predictive value of the test; the choice of the test and its predictive value must be justified

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Assuming Equivalence

 The only clinical data considered relevant are the data obtained when the equivalent device is a CE marked medical device used for its intended purpose as stated in the IFU.

Exceptions may be considered. When the equivalent device is not a CE marked device, information on the regulatory status of the equivalent device and a justification for the use of its data should be included in the clinical evaluation report. The justification should explain if the clinical data are transferable to the European population, and an analysis of possible gaps for good clinical practice (e.g. ISO 14155) and the relevant harmonized standards.

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Stage 3: Analysis of the clinical data

Analysis the data, whereby conclusions are reached about:  Compliance with the essential requirements in terms of performance and safety, including the ratio benefit / risk  The contents of the supporting documents  Residual risks and uncertainties or Questions unanswered (including rare complications, long-term performance, safety during use in "real life"), if these are acceptable for CE marking, it is necessary that they are followed up by PMS

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Stage 4: Clinical Evaluation Report

 Compilation of relevant clinical data, to establish sufficient clinical evidence necessary to demonstrate compliance.  Outlines all stages of the clinical evaluation:

  • Stage 0, scope of he clinical evaluation
  • Stage 1, identification of pertinent data
  • Stage 2, appraisal of pertinent data
  • Stage 3, analysis of the clinical data

 CER: approved, dated – Controlled document (QS)  CV and declaration of interests

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The new developments of MEDDEV 2.7.1 rev 4:

Active update of the CER – When ?

 Frequency defined and justified, based on criteria (risk, innovation, changes)  If new information coming from the PMS, potentially impacting the current evaluation  If no new information is coming from the PMS:

  • At least annually if the DM is at risk and / or innovative
  • Every 2 to 5 years, if the DM is not at risk and / or

innovative, with justification

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The new developments of MEDDEV 2.7.1 rev 4:

Active update of the CER – Why ?

 Ratio benefit/risk profile, side effects and risk mitigation measures:

  • Confirmation of Safety and acceptance per current state of the art
  • Accuracy/relevance of device information materials
  • Accuracy of PMS plan

 Confirmation of existing claims  Justification of new claims

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Clinical Evaluation

  • Sufficient clinical evidence to meet

ERs?

  • Significance of any clinical risks after

risk control?

Risk Management

  • Are all clinical risks in RMR?
  • Risk control identified and verified?
  • Benefit/Risk ration justified?

Post-Market Surveillance

  • Define the PMS Plan based on the

subtle and long term effects to be investigated

  • Is PMCF study needed as part of the

PMS plan?

Information Materials

  • Is the IFUs accurate?
  • Si all the safety information displayed

in IFUs reflected in the RMR?

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LNE / G-MED North America, Inc. 3930 Knowles Ave. Suite 306 Kensington, Maryland 20895 Office: (301) 495-0477 E-mail : contact@lne-america.com

Thank you!