Requirements on clinical data in Europe - TÜV SÜD · Requirements on clinical data ... Depending...

Requirements on clinical data in Europe Dr. Bassil Akra Director Global Clinical Affairs

TÜV SÜD Product Service

Current Medical Device Directives

TÜV SÜD Product Service Slide 2

Applicable Directives • Active Implantable Medical Devices AIMDD 90/385/EEC accepted: 20.06.90; adopted: 01.01.93; end of transition: 31.12.94 • Medical Devices MDD 93/42/EEC accepted: 14.06.93; adopted: 01.01.95; end of transition: 13.06.98 • In Vitro Diagnostics IVDMDD 98/79/EC accepted: 27.10.98; published: 07.12.98; adopted: 07.06.2000; end of transition: 07.12.2003

Where are we heading to ?

MDD AIMD IVDD

MEDDEV 2.7.1

2007/47EG

Rec. 2013/473

920/2013


Current Requirements for Clinical Data


Dir. 2007/47/EC Which medical devices require a clinical evaluation? ALL Medical Devices regardless of Classification Annex I: Demonstration of conformity with the essential requirements must include a

clinical evaluation in accordance with Annex X

One focus of the new regulations will be clinical evaluation

Clinical Evaluation according to current MEDDEV 2.7.1 Rev. 3


Clinical Evaluation The assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer.

EU Regulations Proposal – Clinical Evaluation


Article 4: Placing on the market and putting into service A device shall meet the general safety and performance requirements which

apply to it, taking into account its intended purpose.

Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation in accordance with Artilce 49.

Current Requirements for Clinical Data


Dir. 2007/47/EC - CLINICAL DATA The safety and/or performance information that is generated from the use of a device

SOURCE OF CLINICAL DATA

Studies reported in scientific literature of a similar device (EQUIVALENCY)

Published and/or unpublished reports

Clinical investigation(s) of the device concerned

EU Regulations Proposal – Clinical Evaluation


Article 49: Clinical Evaluation Manufacturers shall conduct a clinical evaluation in accordance with the principles

set out in this Article and Part A of Annex XIII.

A clinical evaluation shall follow a defined and methodologically sound procedure based on either of the following:

A critical evaluation of the relevant scientific literature A critical evaluation of the results of all clinical investigations A critical evaluation of the combined clinical data

Equivalence Approach based on current available literature


Same intended use

(Clinical condition/Disease, Severity, Application Site, Patient Population, Critical Performance Parameter) +

Technical and biological equivalence +

No clinically significant difference regarding safety and performance

Clinical Evaluation – Example 1

TÜV SÜD Product Service http://www.orthopaedicsurgeon.com.sg/total-hip-replacement/ Slide 10

Which route should you follow for the device under consideration?

Example of available competitors New Device

Clinical Evaluation – Example 2



Example of available competitors New Device

A

B http://www.exac.com/patients-caregivers/joint-replacement-surgery/hip-replacement/components-hip-replacement http://evertsmith.com/innovations/

http://www.exac.com/patients-caregivers/joint-replacement-surgery/hip-replacement/components-hip-replacement

http://evertsmith.com/innovations/

Clinical Evaluation – RISK MANAGEMENT PROCESS



IDEA

RISK IDENTIFICATION METHODS

RISK MITIGATION METHODS

RESIDUAL RISKS ACCEPTABILITY

Clinical Evaluation according to MEDDEV 2.7.1 Rev. 3


Clinical Evaluation Report

Stage 3Analysis of

relevant data

Stage 2Appraisal of

individual data sets

Stage 1Identification of

Clinical Data

Sufficient?

Generateadditional clinical

Data

NO YES

Determination ofScope

Clinical Investigation Route


MEDDEV 2.7/4 – When should a clinical investigation be undertaken? Decision Tree General Classification Rules • Class III

• Implants, Most Cardiovascular Devices • Class IIb

• Energy/Substance Delivering, Ionizing Radiation Emitting, Long Term Surgically Invasive Devices

• Class IIa • Most Active & Short Term Surgically Invasive

• Class I • Wheelchairs, Surgical Instruments

Current Clinical Investigation Route Requirements


MEDDEV 2.7/4 – When should a clinical investigation be undertaken? The Conformity Assessment process for active implantable medical devices as well as

for class III and implantable medical devices requires that a clinical investigation is undertaken unless it is duly justified to rely on existing data. Section 1.2 of Annex 7 of directive 90/385/EEC Section I.1a of Annex X of directive 93/42/EEC

Current Clinical Investigation Route Requirements


MEDDEV 2.7/4 – When should a clinical investigation be undertaken? Depending on clinical claims, risk management outcome and on the results of the

clinical evaluation, clinical investigations may also have to be performed for non-implantable medical devices of classes I, IIa and IIb.

Additional clinical investigations may be feasible to corroborate the existing clinical evidence with regard to aspects of clinical performance, safety, benefit/risk-ratio or to determine relative effectiveness and safety with suitable comparators.

EU Regulations Proposal – Clinical Investigations Requirements


Preamble (46) in the proposed regulation Clinical data of Class III medical devices and

Implantable medical devices should be, as a general rule, based on clinical investigations to be carried out under the responsibility of a sponsor.

Preamble (47) in the proposed regulation Clinical investigations in line with major

international guidance in this field, such as the international standard ISO 14155:2011.

Clinical Investigation Route


Clinical Investigation

Sponsor

Investigation site

Qualified investigators

CIB Annex B

normative

CIP Annex A

normative

Informed consent form

Insurance Favorable opinion of

ethics committee

Approval of Competent Authority

EU Regulations Proposal - Clinical Investigations Requirements


Preamble (48) in the proposed regulation An electronic system should be set up at Union level to ensure that every clinical investigation is registered in a publicly accessible database.

No personal data of subjects participating in a clinical investigation should be recorded in the electronic system.

Preamble (51) in the proposed regulation This Regulation should only cover clinical investigations which pursue regulatory purposes laid down in this Regulation.

Already there


Three Annexes: I. Product Assessment II. Quality System Assessment III. Unannounced Audit

Annex I – Product assessment


Notified Bodies should: Review All relevant preclinical data Clinical evaluation Post-market clinical follow-up undertaken or planned

Verify the clinical evaluation is up-to-date Assess the need for and appropriateness of a post- market clinical follow-up plan

April 2014

EU Regulations Proposal - Resource Requirements


Manufacturers have to perform qualified clinical evaluations

Designating authorities have to employ qualified staff

Notified Bodies have to employ qualified staff



At all times and for each conformity assessment procedure and each kind or category of products in relation to which it has been notified, a notified body shall have within its organization the necessary administrative, technical and scientific personnel with technical knowledge and sufficient appropriate experience relating to medical devices and the corresponding technologies to perform the conformity assessment tasks, including the assessment of clinical data.


TÜV SÜD Product Service Slide 24 TÜV SÜD Product Service Slide 24

Radiology Cardiology

Orthopedic Surgery

Neurology

Add value by

know-how

General Medicine

Computer Science

Electrical Engineering

Chemical Engineering

Biological Science

Mechanical Engineering

Medical Science

Environmental Science


TÜV SÜD Product Service Slide 25 New Clinical Data Requirements in the EU

Notified bodies shall have available personnel with clinical expertise. This personnel shall be integrated in the notified body’s decision-making process in a steady way in order to: Identify when specialist input is required Appropriately train external clinical experts Be able to discuss and challenge the clinical data contained in the CER Be able to ascertain the comparability and consistency of the clinical Assessments conducted by clinical experts Be able to make an objective judgment

April 2014

PMCF Requirements according to current MEDDEV 2.12/2 Rev. 2


Why PMCF?

Rare complications or problems become apparent after wide-spread or long term use of the device

An appropriate PMS Plan is key to identifying and investigating residual risks associated with the use of medical devices placed on the market

To confirm the safety and performance throughout the expected lifetime of the device, the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence

PMCF Requirements according to current MEDDEV 2.12/2 Rev. 2


PMCF is mandatory per example, for: Innovative Products Significant changes High product related risks High risk anatomical locations/target populations Emergence of new information on safety or performance Where CE marking was based on equivalence Unanswered questions of long-term safety and performance

EU Regulations Proposal – PMCF Requirements


Why PMCF? To confirm the safety and performance throughout the expected lifetime of the device, the continued acceptability of identified risks and to detect emerging risks on the basis of factual evidence

Systematic registries for Class IIb and Class III devices

EU Regulations Proposal – Scrutiny Procedure

Proposal Commission


Proposed Scrutiny Procedure (Article 44, Page 66) Medical Devices Directives revision proposal

Manufacturer Submission

Notified Body

Notified Body Review

Notified Body Pre-report

Commission

Medical Devices Coordination Group MDCG T= 28 Days

Scrutiny? Scrutiny Start

MDCG Scrutiny

Notified Body Approval Board

T= 60 Days

MDCG final comment

CE

Consider

EU Regulations Proposal – Scrutiny Procedure

Proposal Parliament


Manufacturer Submission SNB SNB Evaluation

Commission

MDCG T= 20 Days

Scrutiny?

SNB Approval Board CE

If scrutiny

Evaluation of CER, PMCF

and other relevant doc

T= 30 Days*

*Clock Stop System

Opi

nion

°

°Appeal procedure

Follow

Summary: what to expect in the future?

TÜV SÜD Product Service Slide 31 New Clinical Data Requirements in the EU

Notified bodies

will

Involve external

clinical experts if deemed necessary

Discuss and challenge the clinical data contained in

the CER

Challenge the comparability

and consistency of

the clinical data

TÜV SÜD Product Service Slide 32 Lighting Services

Dr. Bassil Akra Director - Global Clinical Affairs For enquiries, email me at: [email protected]

Questions?

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