Changes to the Medical Device Legislation in Europe – The Impact of Directive 2007/47/EC Kevin Webb Head of Regulatory & QA Mediqol Limited

Background 5-year review of Directive 93/42/EEC (Article 11) MDEG report (2002) Draft Public Consultation Text (March 2005) Proposal for amending Directive (December 2005)

Background

5-year review of Directive 93/42/EEC (Article 11)

MDEG report (2002)

Draft Public Consultation Text (March 2005)

Proposal for amending Directive (December 2005)

Background Directive 2007/47/EC published 21 September 2007 amends: Directive 93/42/EEC (MDD) Directive 90/385/EEC (AIMD) Directive 98/8/EC (biocidal products)

Background

Directive 2007/47/EC

published 21 September 2007

amends:

Directive 93/42/EEC (MDD)

Directive 90/385/EEC (AIMD)

Directive 98/8/EC (biocidal products)

Background Directive 2007/47/EC implementation arrangements: Directive entered into force on 11 October 2007 national transposition due by 21 December 2 008 compliance mandatory from 21 March 2010

Background

Directive 2007/47/EC

implementation arrangements:

Directive entered into force on 11 October 2007

national transposition due by 21 December 2 008

compliance mandatory from 21 March 2010

Principal Changes Alignment of Directive 90/385/EEC with Directive 93/42/EEC Medical software Clarification of single use Interface with other EU Directives Transparency arrangements EU Authorised Representative

Principal Changes

Alignment of Directive 90/385/EEC with Directive 93/42/EEC

Medical software

Clarification of single use

Interface with other EU Directives

Transparency arrangements

EU Authorised Representative

Principal Changes Medical device reprocessing Drug - device combinations Conformity assessment under Article 11. Conformity assessment under Article 12. Custom-made devices Clinical investigation requirements

Principal Changes

Medical device reprocessing

Drug - device combinations

Conformity assessment under Article 11.

Conformity assessment under Article 12.

Custom-made devices

Clinical investigation requirements

Principal Changes Essential requirements Annex II - Annex VII conformity assessment requirements Statement concerning devices for special purposes Classification Clinical evaluation requirements

Principal Changes

Essential requirements

Annex II - Annex VII conformity assessment requirements

Statement concerning devices for special purposes

Classification

Clinical evaluation requirements

Alignment of 90/385/EEC with 93/42/EEC Text of 90/385/EEC modified to bring it into line with 93/42/EEC. 90/385/EEC – Article 11. An AIMD manufacturer must register with the CA of the Member State in which the manufacturer has its registered place of business. All other changes follow those of 93/42/EEC.

Alignment of 90/385/EEC with 93/42/EEC

Text of 90/385/EEC modified to bring it into line with 93/42/EEC.

90/385/EEC – Article 11.

An AIMD manufacturer must register with the CA of the

Member State in which the manufacturer has its registered place

of business.

All other changes follow those of 93/42/EEC.

Medical Software 93/42/EEC - Article 1: 2. (a) Software specifically for diagnostic / therapeutic use is a medical device BUT NOT software intended for general purposes, when used in a healthcare setting (Recital 6 of 2007/47/EC). 93/42/EEC - Annex IX: 1.4 Stand-alone medical software is an active medical device.

Medical Software

93/42/EEC - Article 1: 2. (a)

Software specifically for diagnostic / therapeutic use is a

medical device

BUT NOT software intended for general purposes, when

used in a healthcare setting (Recital 6 of 2007/47/EC).

93/42/EEC - Annex IX: 1.4

Stand-alone medical software is an active medical device.

Medical Software Software introduces new issues which mean that not all conformity assessment procedures adequately address safety. Application of a QS with adapted design controls should be used. 93/42/EEC – Annex 1, ER 12.1a (new) “ For medical devices that incorporate software, or which are medical software in themselves, the software must be validated according to the state of the art, taking into account the principles of development lifecycle, risk management, validation and verification.”

Medical Software

Software introduces new issues which mean that not all

conformity assessment procedures adequately address safety.

Application of a QS with adapted design controls should be used.

93/42/EEC – Annex 1, ER 12.1a (new)

“ For medical devices that incorporate software, or which are medical software in themselves, the software must be validated according to the state of the art, taking into account the principles of development lifecycle, risk management, validation and verification.”

Medical Software Recommended reading - Guidance document ref. NB-MED/2.2/Rec4, Software and Medical Devices, (2001).

Medical Software

Recommended reading - Guidance document ref.

NB-MED/2.2/Rec4, Software and Medical Devices, (2001).

Clarification of Single Use aim to differentiate from ‘single patient use’ and address risks from re-use. 93/42/EEC - Article 1: 2(n) “ ‘ single use device’ means a device intended to be used once only, for a single patient.” 93/42/EEC – Annex I, ER 13.3(f) (new) “ A manufacturer’s indication of single use must be consistent across the Community.”

Clarification of Single Use

aim to differentiate from ‘single patient use’ and address risks from re-use.

93/42/EEC - Article 1: 2(n)

“ ‘ single use device’ means a device intended to be used once only, for a single patient.”

93/42/EEC – Annex I, ER 13.3(f) (new)

“ A manufacturer’s indication of single use must be consistent across the Community.”

Clarification of Single Use 93/42/EEC – Annex I, ER 13.6(h) For a single use device, the manufacturer must provide info. on known characteristics of it, which could pose a risk if the device were to be re-used.

Clarification of Single Use

93/42/EEC – Annex I, ER 13.6(h)

For a single use device, the manufacturer must provide info. on

known characteristics of it, which could pose a risk if the device

were to be re-used.

Interface with other EU Directives 93/42/EEC – Article 1:6. & 1:8. where a medical device also falls within the scope of Directive 89/686/EEC on PPE, by virtue of its intended use, the device must also comply with the relevant basic health and safety requirements of this Directive. medical devices emitting ionising radiation must comply with the requirements of Directives 96/29/Euratom and 97/43/Euratom, concerning protection of the health of individuals against danger arising from such radiation.

Interface with other EU Directives

93/42/EEC – Article 1:6. & 1:8.

where a medical device also falls within the scope of Directive

89/686/EEC on PPE, by virtue of its intended use, the device must also comply with the relevant basic health and safety requirements of this Directive.

medical devices emitting ionising radiation must comply with the requirements of Directives 96/29/Euratom and 97/43/Euratom, concerning protection of the health of individuals against danger arising from such radiation.

Interface with other EU Directives 93/42/EEC – Article 3. where a medical device also falls within the scope of Directive 2006/42/EC on machinery, for relevant hazards, the device must also comply with the essential health and safety requirements of this Directive, where these are more specific than in 93/42/EEC.

Interface with other EU Directives

93/42/EEC – Article 3.

where a medical device also falls within the scope of Directive

2006/42/EC on machinery, for relevant hazards, the device must also comply with the essential health and safety requirements of this Directive, where these are more specific than in 93/42/EEC.

Transparency arrangements 93/42/EEC – Article 10:3. For reportable incidents involving a medical device, Member State CAs must inform other Member State CAs and the EU Commission of the incident and the corrective actions taken or proposed to minimise the risk of recurrence. 93/42/EEC – Article 14:1 Member State CAs may request to be informed of all data allowing for identification and labelling of Class IIa, Class IIb and Class III devices, when the devices are put into service within their territory.

Transparency arrangements

93/42/EEC – Article 10:3.

For reportable incidents involving a medical device, Member State CAs must inform other Member State CAs and the EU Commission of the incident and the corrective actions taken or proposed to minimise the risk of recurrence.

93/42/EEC – Article 14:1

Member State CAs may request to be informed of all data allowing for identification and labelling of Class IIa, Class IIb and Class III devices, when the devices are put into service within their territory.

Transparency arrangements 93/42/EEC – Article 14a EU databank to be implemented by 5 Sep. 2012, and the EU Commission to evaluate its functionality by 11 Oct. 2012. info. to be included in the EU databank will now include manufacturer and EUAR registration data under article 14, and data relating to clinical investigations intended to demonstrate safety and performance. 93/42/EEC – Article 16.5 Each Notified Body must inform its CA and other NBs of the details of all CE Marking certificates issued, amended, suspended, withdrawn or refused.

Transparency arrangements

93/42/EEC – Article 14a

EU databank to be implemented by 5 Sep. 2012, and the EU

Commission to evaluate its functionality by 11 Oct. 2012.

info. to be included in the EU databank will now include

manufacturer and EUAR registration data under article 14, and data relating to clinical investigations intended to demonstrate safety and performance.

93/42/EEC – Article 16.5

Each Notified Body must inform its CA and other NBs of the details of all CE Marking certificates issued, amended, suspended, withdrawn or refused.

Transparency arrangements 93/42/EEC – Article 15:6 Concerning clinical investigations conducted in accordance with Article 15 (i.e. with non-CE Marked devices), Member State CAs shall communicate with each other and with the EU Commission the following information: all decisions to refuse a clinical investigation approval; all decisions to terminate an approved clinical investigation early on safety grounds; all decisions involving significant modification or temporary interruption to an approved clinical investigation

Transparency arrangements

93/42/EEC – Article 15:6

Concerning clinical investigations conducted in accordance with Article 15 (i.e. with non-CE Marked devices), Member State CAs shall communicate with each other and with the EU Commission the following information:

all decisions to refuse a clinical investigation approval;

all decisions to terminate an approved clinical investigation early on safety grounds;

all decisions involving significant modification or temporary

interruption to an approved clinical investigation

Transparency arrangements 93/42/EEC – Article 20. Defines that certain information concerning the device and the manufacturer shall not be treated as confidential, in order to facilitate transparency: - info. on registration under Article 14 of manufacturers and EU Authorised Reps (EUAR). - info. provided by a manufacturer, EUAR or distributor in relation to a field safety corrective action. - info. contained in CE Marking certificates.

Transparency arrangements

93/42/EEC – Article 20.

Defines that certain information concerning the device and the manufacturer shall not be treated as confidential, in order to facilitate transparency:

- info. on registration under Article 14 of manufacturers and EU

Authorised Reps (EUAR).

- info. provided by a manufacturer, EUAR or distributor in relation to a field safety corrective action.

- info. contained in CE Marking certificates.

Transparency arrangements 93/42/EEC – Article 20(a) (new). Member State CAs will exchange such information with each other and the EU Commission to enable uniform application of the Directive.

Transparency arrangements

93/42/EEC – Article 20(a) (new).

Member State CAs will exchange such information with each other and the EU Commission to enable uniform application of the Directive.

EU Authorised Representative 93/42/EEC – Article 14:2. Manufacturers based outside the European Community must designate a single EUAR. The designation of the EUAR should at least cover all devices of the same model (Directive 2007/47/EC, Recital 14)

EU Authorised Representative

93/42/EEC – Article 14:2.

Manufacturers based outside the European Community must designate a single EUAR.

The designation of the EUAR should at least cover all devices of the same model (Directive 2007/47/EC, Recital 14)

Device Reprocessing Recognition of risks associated with device reprocessing Proposal to reclassify Class I reusable surgical instruments included in Draft Public Consultation Text, but dropped from final proposal following industry pressure. 93/42/EEC – Article 12a (new) EU Commission will report to the EU Parliament on this issue by 5 Sep. 2010. Based on the report, the EU Commission may submit to the Parliament a further proposal in respect of device reprocessing, to ensure a high level of protection of health.

Device Reprocessing

Recognition of risks associated with device reprocessing

Proposal to reclassify Class I reusable surgical instruments

included in Draft Public Consultation Text, but dropped from final proposal following industry pressure.

93/42/EEC – Article 12a (new)

EU Commission will report to the EU Parliament on this issue by 5 Sep. 2010. Based on the report, the EU Commission may submit to the Parliament a further proposal in respect of device reprocessing, to ensure a high level of protection of health.

Drug - Device Combinations 93/42/EEC – Article 1:5(c) For devices incorporating as an integral part a medicinal substance falling within the scope of Directive 2001/83/EC, the decision as to which Directive the product is regulated under will be based on the principal mode of action.

Drug - Device Combinations

93/42/EEC – Article 1:5(c)

For devices incorporating as an integral part a medicinal

substance falling within the scope of Directive 2001/83/EC, the decision as to which Directive the product is regulated under will be based on the principal mode of action.

Drug - Device Combinations 93/42/EEC – Annex I, ER 7.4 NB is now responsible for verifying usefulness of the medicinal substance (as a constituent of the device), while medicine CA remains responsible for verifying quality and safety of the medicinal substance. the clinical risk / benefit profile of the incorporation of the medicinal substance into the device must be taken into account by the medicine CA. a further consultation with the medicine CA is required for changes to the medicinal substance (and its manufacture) .

Drug - Device Combinations

93/42/EEC – Annex I, ER 7.4

NB is now responsible for verifying usefulness of the medicinal

substance (as a constituent of the device), while medicine

CA remains responsible for verifying quality and safety of the

medicinal substance.

the clinical risk / benefit profile of the incorporation of the medicinal substance into the device must be taken into account by the medicine CA.

a further consultation with the medicine CA is required for changes to the medicinal substance (and its manufacture) .

Drug - Device Combinations 93/42/EEC – Annex II, §4.3 & Annex III, §5. Medicine CA must provide its opinion of the safety and quality of a medicinal substance incorporated into a device within 210 days of receiving the information required for its review .

Drug - Device Combinations

93/42/EEC – Annex II, §4.3 & Annex III, §5.

Medicine CA must provide its opinion of the safety and quality of a medicinal substance incorporated into a device within 210 days of receiving the information required for its review .

Conformity Assessment – Article 11 CE certificates issued under Annex V and VI will be valid for no more than 5 years.

Conformity Assessment – Article 11

CE certificates issued under Annex V and VI will be valid for no more than 5 years.

Conformity Assessment – Article 12 Anyone who sterilises a device, system or procedure pack (intended to be user-sterilised) and places it on the market in the sterile condition must undertake conformity assessment for the sterilisation process applied, in accordance with Annex II or Annex V.

Conformity Assessment – Article 12

Anyone who sterilises a device, system or procedure pack (intended to be user-sterilised) and places it on the market in the sterile condition must undertake conformity assessment for the sterilisation process applied, in accordance with Annex II or Annex V.

Custom Made Devices 93/42/EEC – Article 4:2 Manufacturers of custom made devices must make the statement made under Annex VIII available to the named patient on request. 93/42/EEC - Annex VIII Custom made devices now subject to post-market surveillance equirements, including vigilance reporting to CAs

Custom Made Devices

93/42/EEC – Article 4:2

Manufacturers of custom made devices must make the

statement made under Annex VIII available to the named patient on request.

93/42/EEC - Annex VIII

Custom made devices now subject to post-market surveillance equirements, including vigilance reporting to CAs

Clinical Investigation 93/42/EEC – Article 15 The authorisation process for clinical investigations with non-CE Marked medical devices will include a review of the clinical investigation plan.

Clinical Investigation

93/42/EEC – Article 15

The authorisation process for clinical investigations with non-CE Marked medical devices will include a review of the clinical investigation plan.

Clinical Investigation Requirements 93/42/EEC – Article 15:2 & 15:3 The authorisation process for clinical investigations with non-CE Marked medical devices will include a review of the clinical investigation plan. 93/42/EEC – Article 15:7 The manufacturer or EUAR must inform the Member State CA when a clinical investigation taking place in a Member State ends, including a justification for any early termination of the investigation.

Clinical Investigation Requirements

93/42/EEC – Article 15:2 & 15:3

The authorisation process for clinical investigations with non-CE

Marked medical devices will include a review of the clinical

investigation plan.

93/42/EEC – Article 15:7

The manufacturer or EUAR must inform the Member State CA

when a clinical investigation taking place in a Member State

ends, including a justification for any early termination of the

investigation.

Essential Requirements 93/42/EEC – Annex 1, ER 1 Adds requirement to consider ergonomic design features 93/42/EEC – Annex 1, ER 6(a) Emphasises requirement for conformity assessment to include a clinical evaluation 93/42/EEC – Annex 1, ER 7.1 Specifies the requirement for the results of biophysical modelling used in device design to be appropriately validated

Essential Requirements

93/42/EEC – Annex 1, ER 1

Adds requirement to consider ergonomic design features

93/42/EEC – Annex 1, ER 6(a)

Emphasises requirement for conformity assessment to include a

clinical evaluation

93/42/EEC – Annex 1, ER 7.1

Specifies the requirement for the results of biophysical modelling

used in device design to be appropriately validated

Essential Requirements 93/42/EEC – Annex 1, ER 7.5 Adds requirement for manufacturers to pay special attention to device constituents with carcinogenic, mutagenic, reproductive toxic potential. Devices which contain phthalates, and which are intended to channel, transport or store medicines, body fluids or other substances for administration must be labelled to show presence of phthalates. 93/42/EEC – Annex 1, ER 13.1 Information supplied by the manufacturer must take account of the knowledge and training of the user.

Essential Requirements

93/42/EEC – Annex 1, ER 7.5

Adds requirement for manufacturers to pay special attention to

device constituents with carcinogenic, mutagenic, reproductive

toxic potential.

Devices which contain phthalates, and which are intended to

channel, transport or store medicines, body fluids or other

substances for administration must be labelled to show presence

of phthalates.

93/42/EEC – Annex 1, ER 13.1

Information supplied by the manufacturer must take account of

the knowledge and training of the user.

Essential Requirements 93/42/EEC – Annex 1, ER 13.6(o) Devices incorporating human blood derivatives must contain details of these derivatives in the IFU provided with 93/42/EEC – Annex 1, ER 13.6(q) The IFU provided with a device must show the date of issue or revision level. 93/42/EEC – Annex 1, ER 14 ER deleted.

Essential Requirements

93/42/EEC – Annex 1, ER 13.6(o)

Devices incorporating human blood derivatives must contain

details of these derivatives in the IFU provided with

93/42/EEC – Annex 1, ER 13.6(q)

The IFU provided with a device must show the date of issue or

revision level.

93/42/EEC – Annex 1, ER 14

ER deleted.

Annex II – VII Conformity Assessment Declaration of Conformity must clearly identify the devices covered. Post-market surveillance must include consideration of clinical experience in the post-production phase Where design / manufacture are subcontracted, the manufacturer must have a procedure (and records) which show the controls in place to ensure the continued efficient operation of the quality system

Annex II – VII Conformity Assessment

Declaration of Conformity must clearly identify the devices

covered.

Post-market surveillance must include consideration of clinical

experience in the post-production phase

Where design / manufacture are subcontracted, the

manufacturer must have a procedure (and records) which show

the controls in place to ensure the continued efficient operation

of the quality system

Annex II – VII Conformity Assessment The technical documentation for a device must: specify whether or not animal tissues are utilised in its manufacture; include details of the preclinical evaluation performed. The conformity assessment undertaken by NBs will: for Class III devices, include a closer examination of the design; for Class IIb devices, include an assessment of the technical documentation for at least one representative device for each generic device group (set of devices having same / similar intended use and technology)

Annex II – VII Conformity Assessment

The technical documentation for a device must:

specify whether or not animal tissues are utilised in its manufacture;

include details of the preclinical evaluation performed.

The conformity assessment undertaken by NBs will:

for Class III devices, include a closer examination of the design;

for Class IIb devices, include an assessment of the technical

documentation for at least one representative device for each

generic device group (set of devices having same / similar intended

use and technology)

Annex II – VII Conformity Assessment The conformity assessment undertaken by NBs will: for Class IIa devices, include an assessment of the technical documentation for at least one representative device for each device subcategory (set of devices having common areas of intended use and technology) The selection of devices for assessment will take account of the novelty of the technology, similarities in design, manufacture and sterilisation, intended use and the findings of previous assessments. NB routine surveillance activities shall include assessment of further samples of device technical documentation

Annex II – VII Conformity Assessment

The conformity assessment undertaken by NBs will:

for Class IIa devices, include an assessment of the technical

documentation for at least one representative device for each

device subcategory (set of devices having common areas of intended

use and technology)

The selection of devices for assessment will take account of

the novelty of the technology, similarities in design, manufacture

and sterilisation, intended use and the findings of previous

assessments.

NB routine surveillance activities shall include assessment of

further samples of device technical documentation

Annex II – VII Conformity Assessment Records (including aspects of the technical documentation) must be kept for 5 years from the date device manufacture, or for the useful life of the device, if greater. For implants records must be kept for 15 years from the date of last manufacture. Conformity assessment of Class I Sterile / Class I Measuring devices may now follow Annex II (for the sterility / measurement aspect) in combination with Annex VII.

Annex II – VII Conformity Assessment

Records (including aspects of the technical documentation) must

be kept for 5 years from the date device manufacture, or for the

useful life of the device, if greater. For implants records must be

kept for 15 years from the date of last manufacture.

Conformity assessment of Class I Sterile / Class I Measuring

devices may now follow Annex II (for the sterility / measurement

aspect) in combination with Annex VII.

Statement Concerning Devices for Special Purposes For custom made devices: include manufacturer’s name & address. For non-CE Marked devices intended for clinical investigation: Include: the clinical investigator’s brochure; confirmation of insurance of participants; informed consent documentation; statement concerning whether or not the device under investigation incorporates a medicinal substance or human blood derivative; statement concerning whether or not materials of animal origin are utilised in manufacture of the device under investigation

Statement Concerning Devices for Special Purposes

For custom made devices:

include manufacturer’s name & address.

For non-CE Marked devices intended for clinical investigation:

Include:

the clinical investigator’s brochure;

confirmation of insurance of participants;

informed consent documentation;

statement concerning whether or not the device under investigation

incorporates a medicinal substance or human blood derivative;

statement concerning whether or not materials of animal origin are

utilised in manufacture of the device under investigation

Classification (Annex IX) Rule 1.7 Amended definition of central circulatory system (for Class III devices under Rules 6, 7 & 8). (includes the aortic arch and the descending aorta as far as the aortic bifurcation) Rule 2.6 Amended definition of continuous use = uninterrupted use (including discontinuation of use followed by immediate replacement with same or identical device)

Classification (Annex IX)

Rule 1.7

Amended definition of central circulatory system (for Class III

devices under Rules 6, 7 & 8).

(includes the aortic arch and the descending aorta as far as the aortic bifurcation)

Rule 2.6

Amended definition of continuous use = uninterrupted use

(including discontinuation of use followed by immediate replacement with same

or identical device)

Classification (Annex IX) Rule 5 Invasive (body orifice) devices intended for connection to a Class I active medical are classified in the same way as their manual counterparts. Rules 6 & 7 Transient use, surgically invasive devices for use in direct contact with the central nervous system are in Class III (Rule 6). Transient and short term surgically invasive devices intended to control a defect of the heart or central circulatory system, by direct contact with these parts of the body, are in Class III.

Classification (Annex IX)

Rule 5

Invasive (body orifice) devices intended for connection to a Class I

active medical are classified in the same way as their manual

counterparts.

Rules 6 & 7

Transient use, surgically invasive devices for use in direct contact

with the central nervous system are in Class III (Rule 6).

Transient and short term surgically invasive devices intended to

control a defect of the heart or central circulatory system, by direct

contact with these parts of the body, are in Class III.

Classification (Annex IX) Rule 15 Devices intended specifically for disinfecting invasive devices are in Class IIb.

Classification (Annex IX)

Rule 15

Devices intended specifically for disinfecting invasive devices are

in Class IIb.

Clinical Evaluation (Annex X) Conformity with the Essential Requirements for a device, including the acceptability of the clinical risk / benefit ratio, will generally require clinical data. This holds true for all classes of device . An evaluation of the clinical data is required, which must follow a defined and methodologically sound procedure. The clinical evaluation can comprise: a critical evaluation of relevant scientific literature on an equivalent device; or, a critical evaluation of the results of all clinical investigations with the device in question; or, a combination of both of the above.

Clinical Evaluation (Annex X)

Conformity with the Essential Requirements for a device, including the

acceptability of the clinical risk / benefit ratio, will generally require

clinical data. This holds true for all classes of device .

An evaluation of the clinical data is required, which must follow a

defined and methodologically sound procedure.

The clinical evaluation can comprise:

a critical evaluation of relevant scientific literature on an equivalent

device; or,

a critical evaluation of the results of all clinical investigations with the

device in question; or,

a combination of both of the above.

Clinical Evaluation (Annex X) For Class III devices, the data for clinical evaluation shall come from clinical investigation with the device concerned, unless adequate justification is provided for use of existing data on another device is pro The outcome of the clinical evaluation shall be documented and be included in the technical documentation for the device. This is required for all classes of device. The clinical evaluation must be actively updated in the post-market phase using data from surveillance of the device and relevant literature. A documented rationale must be provided for not performing post- market clinical follow-up.

Clinical Evaluation (Annex X)

For Class III devices, the data for clinical evaluation shall come from

clinical investigation with the device concerned, unless adequate

justification is provided for use of existing data on another device is pro

The outcome of the clinical evaluation shall be documented and be

included in the technical documentation for the device. This is required

for all classes of device.

The clinical evaluation must be actively updated in the post-market

phase using data from surveillance of the device and relevant literature.

A documented rationale must be provided for not performing post-

market clinical follow-up.

Clinical Evaluation (Annex X) Where a manufacturer determines that clinical evaluation is not required for demonstration of conformity with the Essential Requirements, a documented justification must be provided, which references the outcome of risk management, performance evaluation, bench-testing and preclinical evaluation, and which discusses the capability of these data to demonstrate conformity.

Clinical Evaluation (Annex X)

Where a manufacturer determines that clinical evaluation is not required

for demonstration of conformity with the Essential Requirements, a

documented justification must be provided, which references the

outcome of risk management, performance evaluation, bench-testing

and preclinical evaluation, and which discusses the capability of these

data to demonstrate conformity.