Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qserve Conference 2013)

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Text of Clinical evaluations and impact of the new Regulations y R. Higgins MHRA ( Qserve Conference 2013)

This is the Regulator Title

Clinical Evaluation - The Impact of

The New Regulatory Framework

Rob Higgins .

2

Problems With Notified Body

Assessments

Still some concerns as to how Notified Bodies have addressed this element

Manufacturers have limited understanding

Notified Bodies appear reluctant to challenge in

this area

Improvements have been seen as to how NBs have

handled this activity. However

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Examples of Issues

Notified Bodies issuing certification even though

data was based on unsubstantiated equivalency

studies not complete

No check on MS no objections or ethics committee approvals for EU Investigations

4

Examples of Issues (Cont)

Users supplied with non CE marked products to evaluate - No Notified Body challenge

Notified Bodies not reporting to MEDDEV requirements

Notified Bodies not taking into account the effect of design changes to product during investigations

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CE MARKING

what essential

requirements?

what information?

in vitro / animal data?

clinical data

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STAGES EVALUATION

identify clinical data from

- literature

- clinical experience

- investigation appraisal of data sets

- suitability

- contribution safety, performance

analysis relevant data

- strength of evidence

- conclusions about performance, safety

is clinical evidence sufficient

to demonstrate conformity

with relevant ERs yes produce clinical

evaluation report

generate new or

additional data

no

7

SOURCES OF DATA

literature searching - protocol

- rationale

- sources, extent searches

- selection criteria

- inclusions, exclusions

clinical experience

- pms reports, adverse events, FCAs

clinical investigation

- plan (objectives, numbers, duration, end points)

- compliance

- regulatory authority/REC letters

- modifications - final report

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How is a Clinical Evaluation Performed

Identification of pertinent standards and clinical data.

Appraisal of each individual data set in terms of its relevance, applicability, quality and clinical

significance.

Analysis of the the individual data sets whereby conclusions are reached about the performance,

safety and presentational aspects of the device.

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Who Should perform the Clinical Evaluation ?

Suitably Qualified and have Knowledge of

the device technology and its application

research methodology

diagnosis and management of the conditions intended to be treated or diagnosed by the device

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CLINICAL EVALUATION REPORT

general details

description device, intended purpose

intended indications, claims

context evaluation (old, new technology)

choice clinical data

summary clinical data and appraisal

data analysis (performance, safety, ifu)

conclusions

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CLINICAL EVALUATION REPORT

(Cont)

The clinical evaluation report should be

signed and dated by the evaluator(s) and

accompanied by the manufacturers justification of the choice of evaluator

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Notified Body Assessment of

Clinical Evaluation

As part of a QS conformity assessment procedure

- Assessment of the manufacturers procedure for clinical evaluation

- As part of the representative sampling of devices to

verify the clinical evaluation data for Class IIa and IIb

devices

As part of a design dossier or type examination dossier assessment to assess and verify the validity of the

clinical evaluation report

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LITERATURE REVIEW

Is data sufficient and of appropriate

quality to demonstrate safety, performance

and risk benefit analysis of..

DEVICE IN QUESTION?

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EQUIVALENCE

clinical

same clinical condition, purpose same site, similar population

technical similar specifications, properties, deployment

critical performance, principles operation

biological same materials, same tissues

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Use of existing clinical data

Basically equivalent to proven designs!

Novel features, extra benefits! Regulatory

Marketing Manufacturers cant have it both ways!

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INDICATION FOR CLINICAL INVESTIGATION

new device

new function

new feature

modification

new material

cannot mimic clinical situation

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MHRA NB EXPECTATIONS

Follow MEDDEV 2.7.1 to include NB reporting requirements

Ensure equivalency if Manufacturers have followed literature route based on similar products

Review MS letters of No Objection, especially Comments, for trials performed in EU

Thoroughly investigate cases where data indicates that studies are not complete prior to certification

Raise major nonconformities in cases where Users are supplied with non CE marked products to evaluate

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Proposed Regulations :

Clinical Evaluation

Confirmation that a clinical evaluation must be performed

For Implantable devices and devices falling within Class III clinical investigations shall be performed. Demonstration of

equivalence shall generally not be considered as sufficient

justification for not carrying out a CI.

If safety and performance requirements are not based on clinical data then an adequate justification must be made

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Clinical Investigatons

Contact person must be established in the Union

Must obtain a single identification number

On receipt of application MS has 6 days in which to decide whether the application is valid

35 day period in which a decision must be made

Use of an electronic system

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Clinical Investigatons (cont)

30 day deadline for approval of changes

If the sponsor temporarily halts a clinical investigation on safety grounds then they shall

inform MSs within 15 days

Prescribes the information required to be in Application

21

Clinical Investigations of Devices

Bearing the CE Marking

Post Market Clinical Follow Up Investigations must

be notified to MSs at least 30 days prior to

commencement

22

Clinical Investigations Conducted

in More Than One Member State

Single application via electronic system

Applicant shall propose one MS as the co-ordinator

23

Reviews for Class III Devices

Proposed Regulations

Summary of the preliminary conformity assessment to be reviewed by the MDCG

Parliamentary Committee

Special Notified Bodies to be designated by EMA

Also data to be independently reviewed

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Key Issues

For Implantable devices and devices falling within Class III clinical investigations shall be performed. Demonstration of equivalence shall generally not be considered as sufficient justification for not carrying out a CI

35 day period in which a decision must be made

Post Market Clinical Follow Up Investigations must be notified to MSs at least 30 days prior to commencement

Clinical Investigations conducted in more than one Member State