securing the ce mark for your medical device · 2017-03-30 · definition - accessories zaccessory...

www.highedge.co.uk © High Edge Consulting 2012

MassMEDIC: The European Medical

Device Market – Re-Examined June 13, 2012

Securing the CE Mark for Your Medical

Device

Peter Rose – Managing Director High Edge Consulting Ltd


High Edge Consulting

Worldwide Regulatory

Affairs

Contamination Control

& Microbiology

Sterilization

Auditing

Services

Training

Services

Quality Systems


High Edge Authorized Rep

European Union Authorized Representative


CE Marking

• ‘Passport’ to legally place medical devices on the market in the EFTA & European Union (EU) (total 31 countries)

• CE Marking on a product ensures the free movement of the product

• CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities


Countries of Europe


Why CE Mark

Population

• USA 312 million (September 2011 – US census bureau)

• Europe 857 million (2010, includes Russia & Turkey)

• UK 62 million (June 2011)

Medical Device Market Size

• USA US $ 105.8 billion (2010), world’s largest

• Europe US $ 51.2 billion (2010)

• Germany US $ 19.5 billion (2011), Europe’s largest

• UK US $ 9.0 billion (2011), Europe’s #2 (rising to US $ 10.8bn by 2016)

• France US $ 8.8 billion (2011), Europe’s #3 Source: Espicom


Route Map to CE Marking

Determine that your product is a Medical Device

Classify your product according

to risk category

Chose your conformity

assessment route

Appoint a Notified Body (If applicable)

Construct a Product Technical File

Document ISO 13485 Quality Management

System

Undergo Regulatory Audit and Approval


What is and is not a Medical

Device

3 Medical Device Directives that define what is a Medical Device

93

/42

/EEC

Medical Device Directive

98

/79

/EC

In Vitro Diagnostic Medical Device Directive

(IVDs)

90

/38

5/E

EC

Active Implantable Medical Devices Directive

(AIMDs)


Definitions - MDD

Definition MDD: “any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. Devices are to be used for the purpose of: • Diagnosis, prevention, monitoring, treatment or alleviation of disease.

• Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap.

• Investigation, replacement or modification of the anatomy or of a physiological process

• Control of conception”


FDA Definition of Medical Device

A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

• intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other

animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."


Definition - Accessories

‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;


Definitions – MDD Example

Example: Hip replacement (Femoral Head & Cup)

“any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. Devices are to be used for the purpose of:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease.





Definitions – MDD Example

Example: Condom

“any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. Devices are to be used for the purpose of:

• Diagnosis, prevention, monitoring, treatment or alleviation of disease.





Definitions - IVDs

• Definition IVD: “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: – concerning a physiological or pathological state, or

– concerning a congenital abnormality, or

– to determine the safety and compatibility with potential recipients, or

– to monitor therapeutic measures”


Definitions - IVDs

• Specimen receptacles are considered to be in vitro diagnostic medical devices – “‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.

Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination”


Definitions – IVDs Example

Example: Blood Glucose Tests

“any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

– concerning a physiological or pathological state, or





Definitions – IVDs Example

Example: Chorionic villus sampling (CVS)

“any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

– concerning a physiological or pathological state, or





Definition - AIMDs

• Definition AIMD: “Any medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure”

A device is ‘active’ if it relies for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.


Definition – AIMDs Example

Example: implantable cardiac pacemakers

“Any medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure”



Definition – AIMDs Example

Example: cochlear implants

“Any medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure”



What is and is not a Medical

Device • If it does not meet any of the European Directives then it can

be CE Mark Exempt

• Check Intended Use !


Intended Use

• The intended use statement is the manufacturers stated intentions for the device and all claims and regulations hinge on that

• Important to be consistent with the statement in marketing and literature including salespersons behaviour and website

Cotton Buds: Intended to apply make up or medicine ?

Walking Stick: Intended to compensate for an injury or handicap or just for a hill walker ?

Surface Wipes: Intended to disinfect an endoscope or work surfaces?


Device Classification

• Annex IX of the MDD sets out the classification rules to determine which class a device falls into according to its properties, function and intended purpose

• Devices are assigned to one of three risk categories:

– Class I for low-risk devices,

– Classes IIa and IIb for medium-risk devices and

– Class III for high-risk devices



Example 1: Plasters & Wound Dressings

• Section 1 - Non invasive

• Rule 4

All non-invasive devices which come into contact with injured skin: – Normal plasters for superficial wounds. Class I

– Fly Larvae system for chronic or necrotic wounds. Class IIa

– Absorbent dressing for major trauma. Class IIb



Example 2: Contact Lens

• Section 2 – Invasive

• Rule 5

All invasive devices with respect to body orifices, other than surgically invasive devices and which are not intended for connection to an active medical device or which are intended for connection to an active medical device in Class I: – Short term use. Class IIa

– Long Term use. Class IIb



Example 3: Heart Defibrillation Catheter


• Rule 7

All surgically invasive devices intended for short-term use are in Class IIa unless they are intended:

— either specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body, in which case they are in Class III,

Note: Section 3 “Additional rules applicable to active devices” do not apply in this case



Example 4: Breast Implant


• Rule 8

All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended….


Classification IVDs

• IVDs

– Annex II List A – which includes test kits for HIV, HTLV and Hepatitis and some blood grouping products, including those used to test donated blood

– Annex II List B – which amongst others includes test kits for rubella, toxoplasmosis and phenylketonuria test kits as well as self test kits for blood glucose

– Self Testing – All others


Classification AIMDs

• Active Implantable Medical Devices are considered unique and have no classification except for their designation as an AIMD


Conformity Assessment –Medical Devices

Class I

Non sterile &

Non measuring

Class IIa

Comply with Essential

Requirements

Document Product Technical File

ECDC

Self Declaration


Requirements

Document Product Technical File

ECDC

Self Declaration

Notified Body certificate for

sterility and/or metrology

Comply with Essential Requirements

Annex VII with

Annex V

Audit of the production quality assurance system ISO 13485:2003

(excluding design) by Notified Body

Annex VII with Annex VI

Audit of final inspection and

testing ISO 13485:2003

(excluding design & Manufacture) by

Notified Body

Annex II

Audit of the full quality assurance

system ISO 13485:2003 by Notified Body

CE Mark CE Mark CE Mark CE Mark CE Mark CE Mark

Class I

Sterile and/or

measuring

Submit RG2 to MHRA

Annex VII with Annex IV

EC verification

Examination & testing of each

product or homogenous batch

by Notified Body

Declaration of Conformity


Conformity Assessment –Medical Devices

Class III Class IIb


Requirements

Submit Design Dossier

to Notified Body

Annex II

Audit of the full quality

assurance system ISO

13485:2003 by Notified

Body


Annex III

Type examination by

Notified Body

With Annex V

Production QA

ISO13485: 2003 (excl

design) by NB

Annex II

Audit of the full quality

assurance system ISO

13485:2003 by Notified

Body

CE Mark CE Mark CE Mark CE Mark CE Mark

Annex III

Type examination by

Notified Body

With Annex IV

Every Device/batch

verified by NB (non

sterile only)


Annex III

Type examination by

Notified Body

With Annex VI

Inspection QA (non

sterile only)

ISO13485:2003 (exl

design & manufacture)


Conformity Assessment – IVDs

General Self-testing

List B Products

List A products

Annex III

Excluding Section 6

Self Certification

Annex III

Including Section 6

Design examination

by Notified Body

Annex IV

Full Quality system

audited by Notified

Body

Annex V

EC type examination

by Notified Body

Annex V

EC type examination

by Notified Body

Annex VI Section 5

Batch verification by

Notified Body

CE Mark CE Mark CE Mark CE Mark CE Mark

Annex VII

Production quality

system audit by

Notified Body


Conformity Assessment - AIMDs

• There are no classifications for AIMDs, either devices fall into this definition or they do not

Active Implantable Medical Devices


Annex 2

EC Declaration of Conformity

Audit of the complete quality assurance system

ISO 13485:2003 by Notified Body

CE Mark CE Mark CE Mark

Annex 3 EC Type Examination

by Notified Body with

Annex 4 EC verification

Annex 3 EC Type Examination

by Notified Body with

Annex 5 EC Declaration of

conformity (Production Quality)



The Regulators

• Competent Authorities

– Government Organisations

– 1 per country

– 32 Competent Authorities

– http://ec.europa.eu/health/medical-devices/files/list-of-contact-points-within-the-national_en.pdf

• Notified Bodies

– Commercial Organisations

– Currently 77 NBs

– http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.notifiedbody&sort=name

http://ec.europa.eu/health/medical-devices/files/list-of-contact-points-within-the-national_en.pdf
















http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.notifiedbody&sort=name




Role of Competent Authority

• The organisation appointed by each national government to enforce compliance with the directive in that country


Role of the Notified Body

• Agents of Competent Authority

• Independent but commercial organisations

• Provide services for conformity assessment as required by the MDDs for CE marking

• Conformity assessment may include inspection, quality assurance, type examination or design examination, or a combination of the above


Typical Technical File

Section 1 Device Description

Section 2 Labelling

Section 3 Design & Manufacturing

Section 4 Essential Requirements

Section 5 Risk Analysis & Control

Section 6 Product Verification & Validation


Device Description

• General description

• Product variants and configurations

• Accessories, other medical devices and other products that to be used with

• Intended use statement:

– Medical condition is to be treated

– Intended patient population

– Contraindications

• Description of how the device works including unique features and performance claims


Device Description

• Product specification

• List of components and their materials

– Materials of Animal Origin statement

– Human cells/tissue products/derivatives statement

• Previous generations or similar competitor devices

• Device classification

• Conformity assessment route


Labelling

• All labelling associated with the device

– labels on the device itself

– labels on the primary pack

– labels on the packaging, etc

• IFU (Instructions for Use)

• Sales / Promotional Literature

• A list of countries where the

device will be marketed, and corresponding official languages


Design & Manufacturing

• Description of the design stages applied to the device

• Technical drawings

• Further detail on product design

• General overview of the manufacturing process

• Manufacture, assembly, in process and final product testing, device packaging

– Documentation comprising the Device Master Record

– Critical suppliers including sub-contracted manufacturing processes

• Product Release process


Essential Requirements

• EC Declaration of Conformity

• Full details for product Classification

• Completed Essential Requirements Checklist

• List of Applied Standards


Risk Management

• Risk Management according to EN ISO 14971:2009

– Risk Management Plan

– dFMEA

– pFMEA

– uFMEA

Risk Analysis

Evaluation of overall

residual risk acceptability

Risk Control

Risk Evaluation

Production & Post Production

Info

Risk Management Report


Product Verification & Validation

• Summary of the results of verification and validation activities typically:

– Engineering tests – Laboratory tests – Pre-clinical test data – Published literature inc. relevant competitor products

• Biocompatibility data

• Medicinal substances

• Animal or human cells, tissues or their derivatives

• Sterilization


• Software verification and validation

• Pre-clinical data related to clinical safety and performance of the device.

• Clinical Evaluation

• Shelf Life with supporting data

• Other relevant data

Product Verification & Validation


ISO 13485

• 21 CFR 820 is a great starting point

• ISO 13485 is based on the ISO 9001 format but with additional requirements for medical devices relating to:

– Design

– Special Processes

– Environmental Control

– Traceability

– Documentation records

– Regulatory actions


ISO 13485

EN ISO 13485:2012

• Medical Devices Quality Management Systems- Requirements for Regulatory Purposes

• Requirements section identical to ISO 13485:2012

ISO/TR 14969:2005

• Medical Devices Quality Management Systems Guidance on the Application of ISO 13485: 2003


ISO 13485 Overview

Introduction

Scope

Normative References

Terms & Definitions

0

1

2

3

4

5

6

7

8

Quality Management System

Management Responsibility

Resource Management

Product Realization

Measurement Analysis & Improvement


Questions


Thank You www.highedge.co.uk

[email protected]

Office: +44 115 921 6200

@HighEdgeConsult

High Edge Consulting Ltd

BioCity Nottingham

Pennyfoot Street

Nottingham

NG1 1GF

United Kingdom

securing the ce mark for your medical device · 2017-03-30 · definition - accessories zaccessory...

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