How Malaysian Manufacturerscan fast track to export

marketswith EC certification?

Mourad Kholti4th March 2014

The 17th SE-Asian Healthcare Show,KLCC, Kuala Lumpur

Introduction

Fast track:the quickest and most direct route to achievement of a goal

Contents

DefinitionsClassificationConformity Assessment procedureTechnical DocumentationNotified BodiesAuthorized EU representative

Introduction

Based in Penang (Malaysia), Andaman Medical Sdn. Bhd. is aconsulting firm specializing in Medical Devices Regulatory Affairsand Quality Management.

Expertise:• Product registrations & licensing in ASEAN region• Regulatory Strategies in ASEAN and Europe• Quality Management Systems: (ISO 13485, US FDA 21 CFR part 820, GDPMD)• Clinical Evaluation• Suppliers Auditing• Local Authorized Representation• Certification audit in partnership with a European Notified Body

EU member states

Austria (1995) Belgium (1952) Bulgaria (2007) Croatia (2013) Cyprus (2004) Czech Republic (2004) Denmark (1973) Estonia (2004) Finland (1995) France (1952) Germany (1952) Greece (1981) Hungary (2004) Ireland (1973)

Italy (1952) Latvia (2004) Lithuania (2004) Luxembourg (1952) Malta (2004) Netherlands (1952) Poland (2004) Portugal (1986) Romania (2007) Slovakia (2004) Slovenia (2004) Spain (1986) Sweden (1995) United Kingdom (1973)

Medical Device

‘medical device’ means 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 andnecessary for its proper application, intended by the manufacturerto be used for human beings for the purpose of:— diagnosis, prevention, monitoring, treatment or alleviation ofdisease,— diagnosis, monitoring, treatment, alleviation of or compensationfor an injury or handicap,— investigation, replacement or modification of the anatomy or of a physiological process,— control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;

CE Marking

What the CE marking means?

The CE marking means that a manufacturer is declaring, on his own responsibility, that his product conforms with the relevant essential requirements in the Directives, and that it is fit for its stated, intended purpose. Once satisfied that the device meets the relevant provisions of the Directives and that the relevant assessments have been carried out, the manufacturer signs a ‘Declaration of Conformity’ prior to affixing the CE marking to his product before it is placed on the market.

CE Marking

Don’t get confused between the CE Mark and the China Export

Mark !

Notified bodies

What is a notified body?

A certification organization which the competent authority of a member state designates to carry out one or more of the conformity assessment procedures described in the medical devices directives annexes.(eg AFSSAPS in France, MHRA in UK,…)

A notified body must be qualified to perform all the functions set out in any annex for which it is designated. The designation may be restricted to specified types of devices and/or Annexes.

A notified body's tasks will vary depending on the classification of the products concerned and the conformity assessment route a manufacturer has chosen

Major steps for CE Marking

Classification

The compression therapy knee brace is indicated for relief of weak or injured knees. With comfortable, breathable, soft, smell-free, materials, it is recommended for knee joint distortions and effusions, after surgical interventions, scars treatments, oedemas, sprains and contusions.

Medical device definition:…diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,

Is my product a Medical Device ?

Classification

Which Directive?

Council Directive 90/385/EEC of 20 June 1990*Active implantable medical devices

Directive 98/79/EC of 27 October 1998 In vitro diagnostic medical devices

Council Directive 93/42/EEC of 14 June 1993*Medical devices

Links:On-going revision of the medical device directiveshttp://ec.europa.eu/health/medical-devices/documents/revision/index_en.htmCurrent medical device directiveshttp://ec.europa.eu/health/medical-devices/documents/index_en.htmGuidance MEDDEVshttp://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm

*changed by Directive 2007/47/EC of 5 September 2007. These changes shall apply from 21March 2010.

Classify my product

Rules are defined in Annex IV of the Directive

Basic questions:

• Is the device invasive ? • Is the device surgically invasive, or invasive with respect to body orifices ? • How long is the device used inside the body ? • Is the device electrically powered ?• Do any of the “Special Rules” apply? (rules 13-18) example: blood bags, there is

no need to read anything in Annex IX except Rule 18.

Guidance document: MEDDEV 2. 4/1 Rev. 9

I

IIa

IIb

III

R I S K

Choose my notified body

NANDO List

New Approach Notified and Designated Organizations

Choose my notified body

Criteria to consider when selecting my NB:

• Scope• Certification services (ISO 13485:2012)• Audit method• Contract (NB role)• Member of Team-NB• Other region services (Canada, US, etc…)• Auditors qualification and location

Select my conformity assessment routeAnnex II – EC Declaration of Conformity (Full Quality Assurance System)

Most comprehensive conformity assessment procedure referring to a full quality system including the design phase for new devices or changes of existing devices; Section 4 (Examination of the Design of the Product) applies only to class III devices; this Section is similar to Annex III - EC Type-Examination with the difference that in-house test results obtained by the manufacturer under his full quality management system may be used as the basis of certification; the manufacturer may choose the harmonized standard EN ISO 13485 in combination with the respective guidance standard as the basis of his quality system.

Annex III - EC Type Examination:

EC type-examination is the procedure whereby a notified body ascertains and certifies that a representative sample of the production covered fulfils the relevant provisions of this Directive.

Annex IV - EC Verification:

A conformity assessment procedure in which the Notified Body examines and tests every individual device or devices taken on a statistical basis, if the manufacturer manufactures homogeneous batches; the Notified Body releases individual devices or batches; EC Verification may be applied to class IIa, IIb and III devices.

Annex V - EC Declaration of Conformity (Production Quality Assurance):

A conformity assessment procedure for the quality system of the manufacturer excluding the design phase of new devices but including all other aspects of conformity with the MDD; this conformity assessment procedure is the most suitable procedure for sterile class IIa devices,

Annex VI - EC Declaration of Conformity (Product Quality Assurance):

A conformity assessment procedure for the quality system for manufacturers of devices whose relevant properties can be assessed in final inspection; the manufacturer may base his quality system on the standard EN ISO 13485; this conformity assessment procedure is not suitable for devices involving special manufacturing processes requiring validation, like sterilization;

Annex VII - EC Declaration of Conformity:

A conformity assessment procedure in which the manufacturer himself declares the compliance of his devices with the MDD; suitable for class I devices,and required for class IIa devices in combination with one of the Annexes IV, V, or VI.

Select my conformity assessment route

Class I

EC Declaration of Conformity(sterile or with a measuring

function)

Annex VIIEC Declaration of Conformity

Annex VII

EC Verification

Annex IV

Production Quality Assurance

Annex V

Product Quality Assurance

Annex VI

Class IIa

EC Declaration of Conformity

Annex VIIFull Quality Assurance

Annex II

EC Verification

Annex IV

Production Quality Assurance

Annex V

Product Quality Assurance

Annex VI

Select my conformity assessment route

Class IIb

EC type examination

Annex IIIFull Quality Assurance

Annex II

EC Verification

Annex IV

Production Quality Assurance

Annex V

Product Quality Assurance

Annex VI

Class III

EC type examination

Annex IIIFull Quality Assurance

Annex II

EC Verification

Annex IV

Production Quality Assurance

Annex V

Technical documentation

CE Technical File or Design Dossier shall include:• Device description• Essential Requirements Checklist• Risk Management• Verification and Validation activities• Manufacturing processes• Clinical evaluation• Labelling• Declaration of Conformity

2 guides:• NBMED guide: NB-MED/2.5.1/Rec5 –Technical documentation• GHTF guide:

Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)

Technical documentation

Main elements:

Avoid excessive paperwork!

Technical documentation

Example:

European Authorized Representative

Where a manufacturer who places a device on the market under his own name does not have a registered place of business in EU, he shall designate an authorizedRepresentative

“authorized representative” means any natural or legal person established in theCommunity who, explicitly designated by the manufacturer, acts and may beaddressed by authorities and bodies in the Community instead of the manufacturerwith regard to the latter’s obligations under this directive;”

both the manufacturer and the authorized representative to set up a contract specifying the task and authority the manufacturer will delegate to the authorized representatives

Andaman Medicalchemin des Trefles74200 Thonon les BainsFrance

European Authorized Representative

Role and obligations:

• Authorization to place its name, address, phone number on your device labels etc. Acting as your primary contact point for the EU Authorities.

• Registering of your Risk Class I devices with the Authorities before they are marketed.

• Keeping your technical file documentation ready and available for the European Competent Authorities.

• Protecting your documentation confidentiality because they are authorized to show them to the Competent Authorities only.

• Notification of serious device incidents to the Competent Authorities• Additional services you should ask for:

• Assistance with technical file documentation• Notification of changes and amendments to the Medical Device Directive

that affect your device(s).

European Authorized Representative

Distributor vs Independent Authorized Representative:

• Should my distributor focus on sales & marketing or on Regulatory Affairs? • Will my distributor in France object if the name and address of my UK

distributor in appears on all labelling?• Do I have to scrap all my labels, inserts and packaging, if I change distributors

will it be costly to change all device?• In case of incident due to transportation from the distributor to the end-user,

will my distributor defend his company or mine?• If my distributor is unable to answer the Competent Authority's questions, does

anyone in my company have the necessary skills to do so directly?• Will confidentiality be maintained when placing a technical file containing

design information with my distributor?• Will my distributor stay up to date on regulatory changes in Europe and will

provide me with timely warning when changes affect my devices?

Major steps for CE Marking

How to fast track - Summary

CE marking for other countries?

28 member states but 33 competent authorities

• Liechtenstein• Norway• Switzerland• Iceland• Turkey

But also…• Mutual recognition with Australia• Abbreviated procedure for other countries like China, Singapore, Saudi

Arabia, South-America…

Medical Device Directives Recast

Revision of EU regulations:

Why?• Notified Body consistency• Clinical trials requirements• Different interpretation of regulations by the 33 CA’s• PMS and vigilance implementation• Major incidents (PIP scandal)What?• Combine MD and AIMD in one directive• More scrutiny from CA and NB (unannounced inspections)• More transparency with public access to Database (EUDAMED)• Unique Device Identification (UDI)When?• Enforcement in 2016/2018?

www.andamanmed.cominfo@andamanmed.com

Sources

http://www.mhra.gov.ukhttp://eur-lex.europa.eu

http://medicaldeviceacademy.comhttp://www.dekra-certification.com