CE MARkING FOR MEDICAL DEVICESThe Route to CE Marking

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INTRODUCTIONMedical Devices sold within the European market must have CE Marking affixing to identify claims of safety and compliance with regulatory mandates. The European Union strictly controls the use of CE Marking on Medical Devices. To affix CE Marking, manufacturers may need to work with a recognized Notified Body, such as BSI, to confirm compliance with European regulations (Directives).

The route to CE Marking can be very complex and confusing; manufacturers must be knowledgeable and determined to learn in order to successfully achieve compliance. The Medical Devices market is increasingly global and regulations are constantly evolving. Working with an experienced and recognized Notified Body, such as BSI, who can guide your organization through the regulatory requirements can bring confidence and many benefits to manufacturers who wish to access these global markets.

BSI is respected and recognized as one the largest and leading

Notified Bodies operating in the Medical Devices sector.

As a Notified Body, BSI has established a reputation for being

competent to review the most complex and novel devices that

represent the cutting edge of medical device technology. The BSI

Medical Devices Notified Body consists of a core team of full-time

BSI employed experts who focus on different device technologies

and can draw on a range of leading specialists - an experienced

professional team qualified to deliver consistent, timely and

predictable reviews.

BSI has served the Medical Devices manufacturing industry for over

twenty years, providing respected accredited conformity assessments

of both devices and quality management systems. Your company

can benefit from BSI’s experience, skills and expertise. CE Marking:

• Indicatestogovernmentsand

stakeholders that the product

can be sold legally within the

European Union

• Indicatestogovernments

and stakeholders that your

organization is implementing

accepted practices

• Ensuresthattheproductwill

move freely throughout the

European Market

• Indicatestocustomersthat

the device is intended to

meet safety and quality

requirements

• Promotespatientbenefit

and safety

• Enhancesproductcredibility

• Leadstoimprovedsales

opportunities

CE marking is a legal requirement for Medical Devices intended for sale in Europe.

WORk WITH THE EXPERTS

2 BSI Product Services CE Marking for Medical Devices

CE marking is a legal requirement for devices intended for sale in Europe. The route to achieving CE Marking can seem complex and confusing, but when you partner with a well versed Notified Body, like BSI, this process will move smoothly and efficiently.

The key stages of CE Marking are:

1. Classification of Your Medical Device

2. Identifying and Meeting Essential Requirements

3. Preparing Technical Documentation

4. Completing Required Conformity Assessments

5. Signing a Declaration of Conformity

THE ROUTE TO CE MARkING THE MEDICAL DEVICE DIRECTIVES

Medical Device Directives are guidelines which a Notified Body must abide by when dealing with certain types of classifications of Medical Devices for CE Marking. In addition, the company seeking CE Marking must adhere to the guidelines within the directives.

BSI is designated as a Notified Body with a comprehensive scope under the Medical Devices Directives and Active Implantable Medical Devices Directive.

As a Notified Body under the MDD and the AIMDD, BSI has one of the broadest scopes of any Notified Body.

This means that BSI has the technical expertise and experience to assist and provide appropriate conformity assessment services including:

•TechnicalDocumentation/FileorDesign Dossier Assessment and Review

•DeviceTypeExamination

•ProductQualityAssurance

•ProductionQualityAssurance

•FullQualityAssurance

•BatchVerification/Release

In addition, BSI is also fully prepared to handle your ISO 13485:2003MedicalDevicesQualityManagementSystem.

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THE EU DIRECTIVES IN DETAIL

There are three European CE marking directives that specifically apply to medical devices manufacturers:

The Medical Devices Directive (MDD) applies to medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive.

The Active Implantable Medical Devices Directive (AIMDD) applies to active devices intended to be permanently implanted in humans and related accessories.

The In Vitro Diagnostics Directive (IVDD) applies to all devices and kits used away from the patient to make diagnosis of patient medical conditions.

As a Notified Body under the MDD and the AIMDD, BSI has one of the broadest scopes of any Notified Body.

FURTHER CLASSIFICATION

In addition to falling under a specific EU Directive, Medical Devices under CE Marking are also separated into different classifications in accordance with their level of risk. It is the responsibility of the manufacturer to determine which classification is appropriate for their medical devices. When working with an experienced Notified Body, such as BSI, this decision should be much easier to make.

•ClassI–“lowrisk”devices.Generallynon-invasiveandreusable devices, low significant risks to the patient.

•ClassIIa–“mediumrisk”devices,suchassingleuseinstruments, medium risk active devices and monitors etc.

•ClassIIb–“medium-highrisk”devices,someexamples include long term implants, x-ray units, some contraceptive devices

•ClassIII–“highrisk”devicessuchasdevicesthatcontact the heart and brain, devices with medicinal substances and animal materials etc.

•AIMDD–alldevicesundertheAIMDDaretreatedsimilarly to Class III devices under the MDD.

When deciding what the appropriate classification for a medical device should be, some key areas to be considered include:

•Thenatureofthedevice(ieisitactive,re-usableetc)

•Howlongthedevicewillbeincontactwiththebody

•Thepartofthebodythatthedevicewillbeincontactwith

•Howthedevicewillattachto,penetrateoreffectthebody

•Theintendedpurposeforthedevice

•Anyspecialconsiderations(egincorporating medical substances)

With BSI’s years of experience and skill, determining the classification for you medical device will be a smooth process.

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Every device that carries CE Marking must fully address the relevant essential requirements. These Essential Requirements include:

•FitnessforPurpose–thedevicedoeswhatitis supposed to do

•Safety–thedevice’sdesignandconstructionconformstosafety principles taking account of the state of the art

•Risk/HazardAnalysis–therisksshouldbeevaluatedandshould be far less than the intended benefits

•TransportandStorage–devicesmustbemanufacturedandpackaged in such a way that the intended use will not be affected when transported or stored

•Otherdevicespecificrequirements

A key tool and foundation for addressing the Essential Requirements are harmonized standards covering products and processes; BSI is well versed on the most appropriate standards.

CONFORMITY ASSESSMENT MODULES (ANNEXES)

Depending on the classification of the medical device, certain Conformity Assessment Modules or routes to CE Marking exist to help meet the essential requirements of a CE Mark:

1.AnnexII–FullQualitySystem

2. Annex III – Type Examination

3. Annex IV – Verification

4.AnnexV–ProductionQualitySystem

5.AnnexVI–ProductQualitySystem

6. Annex VII – Declaration of Conformity

Again, depending on the classification of the device, a company must take one (or a combination of two) of these routes to CE Marking. For the Medical Device Directive (MDD) – Annex II or V are the most widely used.

THEESSENTIALREQUIREMENTS

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THEQA(QUALITYASSURANCE)ANNEXES IN DETAIL

For the Medical Device Directive (MDD) the quality assurance conformity assessment routes, Annex II and V are the most commonly used.

Annex IIThis requires a full quality systems assessment (ISO 13485:2003) by the Notified Body and is focused on manufacturer’s ability to consistently design and manufacturer compliant devices (this route is ideal for class IIb and class III devices). For Class III devices under Annex II, a design dossier submission is also required to allow the Notified Body to conduct a detailed review of the manufactures design solutions, clinical data and risk assessment.

Annex VUnder Annex V, production quality system assessment, the Notified Body audits the manufacturer’s quality system and processes covering production using ISO 13485:2003 without the design requirements as a model. The Notified Body is required to establish confidence in the manufacturer’s ability to consistently produce compliant devices.

TECHNICAL DOCUMENTATION

European regulations require technical documentation for all device classifications, irrespective of the Annex being followed to CE Marking. The technical documentation, often referred to as the technical file, contains the information demonstrating conformity with the essential requirements of the directives. It also includes product specifications and manufacturing information. The complexity and risk of the devices determine the scope and level of detail required within the technical file.

BSI has specific guidance on the kind of data that your company’s technical file should contain.

DECLARATION OF CONFORMITY

Once you have gone through the process of CE Marking you must claim conformity through a Declaration of Conformity. This document claims:

•Thedevicesmeettherelevantessentialrequirements

•Appropriateconformityassessmentprocedureshave been completed

•Thedeviceisdesigned,manufacturedandtestedinaccordance with technical documentation

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MEDICAL DEVICE TRAINING

BSI Management Systems offers a comprehensive program of training courses for CE Marking and ISO 13485:2003:

Medical Devices CE MarkingThrough BSI’s CE Marking course students will gain knowledge of the Medical Device Directive and CE Marking approach to provide leadership for their organizations when placing medical devices on the market in the European Union.

Understanding ISO 13485:2003An ideal introduction to the ISO 13485:2003 requirements including the proposed changes that form the basis of the revised standard.

Implementing 13485:2003This course introduces the concepts needed to understand, develop, and implement a quality management system as outlined in the medical devices standard ISO 13485:2003. This course also discusses the use of ISO 14971:2007, which contains key principles and guidance for risk management.

ISO 13485:2003 Internal AuditorProvides the knowledge and skills required to conduct ISO13485:2003QualityManagementSystemsInternalAudits.

ISO 9001:2000 Lead Auditor Course with Emphasis on ISO 13485:2003 This course begins with a review of ISO 13485:2003 and continues to teach the principles of process auditing in accordance with quality management system standards and ISO 19011:2002. In addition, the concepts of ISO 14971:2007 are introduced.

Understanding ISO 14971:2007This course is designed to provide participants with a greater knowledge of ISO 14971:2007. Professionals gain an understanding of how ISO 14971:2007 can improve their business and risk management efforts and will also understand how ISO 14971:2007 applies to ISO 13485:2003.

WEBINARS

BSI also offers a selection of Webinars – interactive online presentations that allow participants to hear the instructor through a telephone conference call while following the presentation element via a webpage.

The following topics are some offered classes in our Webinar suite:

•OverviewofISO14971:2007

•OverviewofCEMarking

•OverviewofISO13485:2003

•OverviewofCMDRandCMDCAS

•RecordedWebinar:Japan-NewRegulationsfor Medical Devices Manufacturers

Visit BSI’s medical devices public training pages for more details on who should attend, the benefits of each course, and the course dates and locations at: www.bsiamerica.com/CEtraining

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