Want toknow moreabout theNotifiedBody?Everything you need to know to help you through the Notified Body process and on to accreditation.

Contents

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3 Meet the world with confidence

4 What is CE marking?

5 Where does the CE mark apply?

6 What is the role of the Competent Authority?

7 What is the role of the Notified Body?

8 How many Notified Bodies are there for the CE mark?

10 Who decides on the content of the Directives?

12 What is the process a manufacturer has to gothrough to get a CE mark?

14 In Vitro Diagnostic products

16 What does a Notified Body have to review as part ofthe assessment process?

18 Does a Notified Body have to see the product as partof the certification process?

20 Faults and alterations

21 Unannounced Audits

22 What a Notified Body does NOT do

23 Further Information

We are a respected, world-classNotified Body dedicated toproviding rigorous regulatoryand quality managementreviews and productcertifications for medical devicemanufacturers — around theworld. For more than 100years, BSI’s expertise hasprovided an assurance of safetyand quality to manufacturers inover 150 countries.

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Our mission is to ensure patient safety while supporting timelyaccess to global medical device technology. We strive to set theglobal standard in thorough, responsive, predictable conformityassessments, evaluations and certifications.

The challenges medical device manufacturers face in today’shighly competitive marketplace make it essential to ensurethat your product meets all regulatory and qualityrequirements before launch. It is critical to work with a leaderwho understands the industry and has the experience to reviewand confirm the products’ readiness for market – efficiently,reliably and promptly. BSI is a company that has been leadingthe way in assisting manufacturers to navigate through themaze of regulatory requirements.

While every effort has gone into this booklet to ensure that it accurately reflects the regulatory environment at the time ofpublication, you should be aware that this is complex and can change. Therefore, this booklet is not to be considered as providingany legal advice and is not to be used as a substitute to reading the regulations directly or seeking advice from a qualified expert.

Meet the worldwith confidence

Hi, I’mTerrence!

Meet Terrence, your personal

guide to the Notified Body.

CE marking is the medical device manufacturer’s claim that aproduct meets the essential requirements of all relevantEuropean Directives and is a legal requirement to place adevice on the market in the European Union.

The three medical devices Directives are:• Medical Devices Directive (MDD) • Active Implantable Medical Devices

Directive (AIMDD) • In Vitro Diagnostics Directive (IVDD)

The EU is currently reviewing all threeMedical Device Directives.

There are a number of other related Directives andRegulations that might need to be considered for example,Regulation 722/2012 concerning active implantable medicaldevices and medical devices manufactured utilising tissues ofanimal origin. This document is to provide a basic overviewand so does not include every necessary detail for yourproduct.

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EU Directives lay down certainend results that must beachieved in every MemberState. National authorities haveto adapt their laws to meetthese goals, but are free todecide how to do so.Regulations are the most directform of EU law - as soon asthey are passed, they havebinding legal force throughoutevery Member State, on a parwith national laws. Nationalgovernments do not take actionthemselves to implement EUregulations, but do ensure their

national law does not definethe subject matter

any further.But where will I be able to take my device

to market ?

What is CE marking?

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Where does theCE mark apply?

*If a device is in a clinical investigation/ performance evaluation (IVD) or is custom made there will be no CE.

The CE mark is applicable in the countries of the “European Economic Area”.

This includes:• The 28 Member States of the EU plus: Iceland, Liechtenstein,

Norway, Switzerland and Turkey.

You can take your device to market any-where in the “European

Economic Area”

IMPORTANT!No medical device can be placedon the market within Europewithout a CE mark to one of thethree medical device Directives,even if the product ismanufactured outside the EU.

Each country within the EU and partner countries has a Competent Authority. TheCompetent Authority is a body within the government of the Member States thattransposes the requirements of the Medical Device Directives into National Law.

The Competent Authority is also responsible for specifying one or more Notified Bodies,to act as independent third party assessors of the manufacturer’s compliance.

What is the role of theCompetent Authority?

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Competent Authoritiesensure that EU Directives areset (legally called Transposed)into each Country’s Law.

The Competent Authority inthe UK is the Medicines andHealthcare ProductsRegulatory Agency (MHRA).

Who is the Competent Authority

in the UK?

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The role of a Notified Body is to conduct a conformity assessmentunder the relevant EU Directives. The Notified Body conducts theconformity assessment against the relevant sections of theapplicable Directive (MDD, AIMDD or IVDD). The conformityassessment usually involves an audit of the manufacturer’s qualitysystem and depending upon the particular classification of thedevice, a review of the relevant technical documentation providedby the manufacturer in support of the safety and performanceclaims for the device. The technical documentation is assessedagainst the essential requirements set out within the EU Directivesand considers the relevant guidance set out by the EU.

Once the Notified Body has determined a manufacturer hasconformed to the relevant assessment criteria, it issues a CE certificateto show that the products assessed meet the requirements.

The manufacturer signs a Declaration of Conformity and applies theCE mark (with or without the Notified Body number).

What is the role of theNotified Body? IMPORTANT!

“The Notified Body and its staffmust carry out the assessmentand verification operationswith the highest degree ofprofessional integrity and therequisite competence in thefield of medical devices andmust be free from all pressuresand inducements, particularlyfinancial, which might influencetheir judgement or the resultsof the inspection, especiallyfrom persons or groups ofpersons with an interest in theresults of the verifications”.

Manufacturers are free tochoose a suitable Notified Body– ensuring that they arequalified and experienced withthe product to be certified.

There are over 70 EU Notified Bodies in total that can certify to the MedicalDevice Directives. However, not all of these Notified Bodies can certify to allcategories of medical device products. Products holding a CE mark from anyof the seventy plus Notified Bodies can be marketed to patients, pharmacies,clinicians and other healthcare professionals in any EU country. 

The three Medical Devices Directives are:• Medical Devices Directive (MDD) • Active Implantable Medical Devices

Directive (AIMDD) • In Vitro Diagnostics Directive (IVDD)

The EU is currently reviewing all three Medical Device Directives.

How many NotifiedBodies are there forthe CE mark?

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NandoVisit the Nando Website to see the accurate list of designatedNotified Bodies: ec.europa.eu/enterprise/newapproach/nando/

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In total there are over 70 EU Notified Bodies.

70+

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Who decides on the content of the Directives?

Input from:• Notified Bodies• Manufacturers• Trade associations • Patient groups• Clinical societies

Input to the Directive:• Member States (Countries)• Member of European

Parliament (MEP)• European Union Citizens

EuropeanCommission

EU CouncilEU Parliament

DRAFT DIRECTIVE

Three partynegotiations:trialogue

Hello I’m the product

manufacturer Hi I’m Terrencefrom BSI

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Legal DirectiveOnce both European Parliament and Council haveapproved the final text of a legislative proposal, it is jointlysigned by the Presidents and Secretaries General of bothinstitutions. After signature, the texts are published in theOfficial Journal and become official. Regulations aredirectly binding throughout the EU as of the date set downin the Official Journal.

The Designating Authority is also responsible forspecifying one or more Notified Bodies, to act asindependent third party assessors of the manufacturer’scompliance.

MHRAThe MHRA is the Competent Authority in the UK. TheCompetent Authority is a body with authority to act onbehalf of the government of the member state to ensurethat the requirements of the Medical Device Directives aretransposed into National Law and are applied. 

Put into Law by EUMember States countryCompetent Authorities

Notified Bodyassessment

Directives lay down end results to be achieved in everymember state, but leaves it up to national governments todecide how to adapt their laws to achieve these goals.Each Directive specifies the date by which the nationallaws must be adapted. Decisions apply in specific cases,involving particular authorities or individuals and are fullybinding.

LEGALDIRECTIVE

MDD and AIMDThe route to follow for certification depends on the riskclassification of the device.  • For Low risk Class I devices the manufacturers self certify's,

applying the CE mark. If the device has a measuring capability oris supplied sterile a Notified Body is however required. 

• For Class IIa (low to medium risk), Class IIb (medium to high risk)and Class III (high risk) devices, a Notified Body audits themanufacturer’s quality system and the manufacturer requires afavourable audit to proceed to CE marking. 

• For Class III devices a Notified Body evaluates the design of themedical device, by reviewing a design dossier submitted by themanufacturer, and issues a certificate of conformity with theDirective if it is satisfied with the device’s safety and performancedata. 

• AIMD, Active Implantable Medical Devices are regarded, by theirvery nature, as high risk devices in terms of the AIMDD(90/385/EEC) and must undergo Full Quality Assurance includingdesign of the product and post market surveillance.

What is the process a manuhas to go through to get a C

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What is the risk classification of my

new glasses?

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facturer E mark?

This chart shows examplesof products that fall into

each class of risk. Glassesare low risk.

Device classification examples

Class Device Examples

I (low risk) • Bandages• Wheelchairs• Corrective glasses and frames

IIa (low to medium risk) • Disposable contact lenses• Suture• Dental fillings

IIb (medium to high risk) • Complex wound dressings for burns• Baby incubators• Dialysis equipment

III (high risk) • Hip replacements• Drug eluting stent• Absorbable sutures

AIMD • Implanted cardiac pacemakers

IVDs are medical devices and accessories used toperform tests on samples, such as blood, urine,tissue, effectively any sample which can be takenaway from the human body to help detectinfection, diagnose a medical condition, preventdisease or monitor drug therapies.

The Directive groups IVDs into four categoriesaccording to the perceived risk associated with therelative hazard to public health and/or patienttreatment by an IVD failing to perform as intended.

In Vitro Diagnosticproducts

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It’s all about the

risk versus benefitbalancing act.

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Definition of an auditAn official inspection ofan individual's ororganization's accounts,typically by anindependent body.

IVD classification examples

IVD Classification Examples

General No Notified Body requiredManufacturer self declares

Tests for Hormones, CardiacMarkers, Hematology andClinical Chemistry Tests

Self Test Notified Body requiredReview of design & labelingfor lay user suitability

Pregnancy, Cholesterol Home Tests

Annex II List B Notified Body requiredAudit of technicaldocumentation & qualitymanagement system

Rubella, PSA,Self Test for Blood Glucose

Annex II List A Notified Body requiredDesign Dossier Review(Including Compliance tothe CTS)Audit of qualitymanagement systemBatches released by theNotified Body

HIV, Hepatitis ABO BloodGrouping

What does a Notified Body review as part of the assess

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Dependent on the particular classification of thedevice, a Notified Body will carry out either a fulltechnical file review or in the case of ClassIII/AIMD/Annex II List A, an in-depth design dossierreview (Risk based and defined within the Directives).The manufacturer must provide all the technicaldocumentation in support of the safety andperformance claims for the device. Technicaldocumentation is assessed against the essentialrequirements set out within the EU Directives; itconsiders the standards, common technicalspecifications, and relevant guidance set out by the EU.

From an EU regulatory perspective there are key requirements to meet, these are contained in the three EUMedical Device Directives (MDD, AIMDD and IVDD). The conformity assessment requires an audit to be carriedout on-site of the manufacturer’s quality system or evidence of a current valid QMS certificate (see below) froma recognised Notified Body.

The CE process includes a Quality Management System(QMS) assessment. A comprehensive audit of thefacility includes, reviewing the manufacturing process,systems, controls, material handling, microbiological &sterile systems etc. The audit is carried out to thestandard ISO 13485 (the harmonized Medical DeviceQMS standard) and has a three year validity; as part ofthis process there is an annual surveillance audit toensure conformity is maintained.

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have to ment process? ISO 13485

The ISO 13485 standard is an effectivesolution to meet the comprehensiverequirements for a qualitymanagement system. Adopting ISO13485 provides a practical foundationfor manufacturers to address theregulations and responsibilities as wellas demonstrating a commitment to thesafety and quality of medical devices.

Congratulations yourproduct has passed.

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Does a Notified Body have to see theproduct as part of the certification process?There are a number of conformity assessment procedures that amanufacturer can follow to CE mark a medical device. The CE processinvolves a Quality Management System (QMS) assessment that reviewsthe design, manufacture, inspection and test processes during whichthere will be direct involvement with the product.

For IVDs Manufacturers with Annex II List A devices are required to haveevery batch of device released by the Notified Body which may oftenrequire testing of the product.

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Hi i’m Terrence. I’ve come to see your

product.

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Faults and alterations

When a product component is altered, whoneeds to do what?It is the responsibility of the manufacturer toinform the Notified Body of any changes to amedical device, and demonstrate to theNotified Body that the changes do notadversely affect the device’s safety andperformance. The Notified Body reviews thesubmitted data against the ‘EssentialRequirements’ of the relevant medical deviceDirective to ensure conformity and to confirmthe certificate remains valid. There aredifferent requirements placed on devicesdependent on its conformity assessment route.

Who is responsible for monitoring andreporting product faults once they have beenreleased onto the market?Once a product is commercialised, it is for themanufacturer to report adverse events andproduct performance issues to the CompetentAuthority. The Competent Authority is requiredto react and respond appropriately in theinterests of patient safety. The relevantCompetent Authority in a given EEA memberstate will co-ordinate the reported eventsunder the EU vigilance system and, whereappropriate, share this information and anyfield safety actions with other member states.

IMPORTANT!The entry of data ontothe European Data Bank(EUDAMED) is theresponsibility of theCompetent Authority ofeach member state.

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Notified Bodies are required under EU legislation to performunannounced audits of medical device manufacturer’s and relatedsupplies. Key requirements from this section of the CommissionRecommendation include the following requirements:• Unannounced audits of the manufacturer or one of its critical

subcontractors or suppliers of crucial components. • The unannounced audit must be additional to the regular

assessment cycle and at least one day by two auditors. • At least one unannounced audit per 3rd year with increased

frequency for high risk device manufacturers and/ormanufacturers with a poor history of compliance, or wherespecific information provides reasons to suspect non-conformities of the devices or their manufacturer.

• Specified areas of focus for the visit.These include manufacturing, testing,linkage of manufactured items to thetechnical file and device specifications,identification and traceability,reconciliation of materials and criticalprocesses, plus further testing of deviceswith a design or type examination certificate.

Unannounced auditsSURPRISE!

I’m Terrence yourBSI auditor.

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The directors, executives and personnel (whether directly employed or subcontracted)responsible for carrying out the evaluation and verification activities shall be independentof both the manufacturers for whom the Notified Body conducts assessments and thecommercial competitors of those manufacturers, during their employment by the NotifiedBody. Personnel shall not have been involved in the design, construction, marketing ormaintenance of the devices.

What a Notified Bodydoes NOT do

Define the Directives The Notified Body does not writeor decide on the EU regulations –their input will be consideredduring the debating stage shownabove but they will not decide onthe legislation. Notified Bodiesassess against the requirementsof the Directives, they do notwrite them.

Consultancy Notified Body personnel (whetherdirectly employed or subcontracted)shall not offer or provide (or haveoffered or provided) consultancy oradvice to the manufacturer, theauthorised representative, a supplieror their commercial competitor asregards the design, construction,marketing or maintenance of theproducts under assessment.

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Further information

Where can I find a full list of Notified Bodies?

Further information may be found on the following websites:• European Commission Health Devices

ec.europa.eu/health/medical-devices• Full list of Notified Bodies and Competent Authorities

ec.europa.eu/enterprise/newapproach/nando/• MHRA

www.mhra.gov.uk/• ZLG

www.zlg.de/en/zlg.html • Notified Body Operations Group (NBOG)

www.nbog.eu/• Team-NB – Association of medical Notified Bodies

www.team-nb.org/

DISCLAIMERWhile every effort has gone into this bookletto ensure that it accurately reflects theregulatory environment at the time ofpublication, you should be aware that this iscomplex and can change. Therefore, thisbooklet is not to be considered as providingany legal advice and is not to be used as asubstitute to reading the regulations directlyor seeking advice from a qualified expert.

Goodbye!BSI Notified Body (0086)Kitemark CourtDavy AvenueKnowlhillMilton KeynesMK5 8PPUnited Kingdom

T: +44 845 080 9000E: eu.medicaldevices@bsigroup.comW: medicaldevices.bsigroup.com

NBG

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