Assess and designate Notified Bodies - TOPRA

Notified Bodies 

Neil Adams B.Sc. Ph.D. 

Director of Healthcare Operations 

BSI, Kitemark House, Maylands Avenue, 

Hemel Hempstead, HP2 4SQ, UK 

+44 (0)1442 278503 

+44 (0)7500 097027 

Neil.Adams@bsigroup.com 

www.bsigroup.com/healthcare

Regulatory Intelligence 

Notified Bodies

In this presentation we will 

cover 

• The roles and interactions of Notified 

Bodies 

• Conformity Assessment 

• Quality Systems 

• Regulatory Working Groups and Task 

Forces 

• Sources of Guidance

What do Notified Bodies do? 

• Assess the conformity of products to the Essential 

Requirements of the Medical Device Directives 

and the Quality Systems used to manufacture 

them to relevant standards 

– This enables manufacturers to affix the CE mark to 

the product and gain entry to the EU market 

• Notified Body involvement increases with the risk 

of product 

– For high risk products, Notified Bodies need very 

significant and varied expertise 

• Manufacturers need expert and stable Notified 

Bodies to provide secure long term market access 

6

Conformity Assessment by 

Notified Bodies 

• Audit Quality Systems 

– Design Process 

– Manufacturing of devices 

– Final Inspection 

Three year cycle 

• Audit Product Design Documentation 

• Test Devices 

– Batch 

– Type 

• Notified Bodies can be: 

– Quality System Registrar 

– Testing Agency 

Five year cycle 

7

Tasks for Notified Bodies 

• Pre-market assessment for medium or high risk 

devices 

– Assess quality systems, production and sterility 

– Review technical files and design dossiers 

• Ongoing evaluation 

– Quality Management System, Post-Market 

Surveillance and Vigilance 

– Changes to design 

– IVD batch verification 

• Re-evaluation and re-certification 

– Audit cycle, multi-site reviews 

– State of art in design 

8

9 

Role of the Member States 

• “Enforcement of Community legislation is an 

obligation on Member States” 

• Carry out market surveillance to make sure 

manufacturers comply 

• Act against persons who wrongly affix CE 

marks 

• Warn citizens and others of risks 

• Assess and designate Notified Bodies 

– Member States do this via a “Competent 

Authority” 

9

10 

Regulating Notified Bodies 

• Competent Authority Designates a Notified Body to Conduct 

Conformity Assessments 

– Notified Body must meet the Directives’ requirements 

– The Scope of Designation based on expertise in the Notified 

Body 

• MHRA is the UK’s Designating Authority 

• Six UK Notified Bodies with different scopes 

– http://www.mhra.gov.uk/Howweregulate/Devices/NotifiedBodies/ 

UKNotifiedBodiesundertheMedicalDevicesDirectives/index.htm 

• Over 80 Notified Bodies in the EU 

– http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fu 

seaction=directive.main 

10

Conformity Assessment Routes 

• If a product complies with the requirements of a new 

approach directive, the manufacturer signs a 

conformity declaration. 

• Depending on the potential risk of the device 

certification by a Notified Body may be required. 

• If certification is a requirement as part of the 

conformity assessment procedure, the manufacturer 

has the option to choose any of the Notified Bodies in 

any of the Member States of the EU. 

• Products which require certification by a Notified Body 

carry the CE-marking in combination with the number 

of the Notified Body, for example:

Conformity Assessment: Risk 

Based Classes 

18 classification rules (Annex IX) 

low Risk high 

sterile 

or with a measuring 

function 

S17

Conformity Assessment: Criteria 

for Risk Classification 

• invasive / non-invasive 

• surgically invasive / non-surgically invasive 

• implantable / non-implantable 

• active / non-active 

• short-term / long-term use 

• application on critical organs: central 

nervous system, central blood circulation 

system 

intended use

Conformity Assessment: 

Examples for Risk Classification 

• Class I 

– wheel chairs, patient beds, non-invasive electrodes 

• Class I* 

– sterile wound dressings, thermometer 

• Class IIa 

– ultrasound diagnostic device, respiration tubes, blood 

pressure monitoring devices, products for transition of 

blood 

• Class IIb 

– Lithotripthers, ablation devices, ventilators 

• Class III 

– prosthetic heart valves, neurologic catheters, artificial 

joints, breast implants, combination products

Conformity Assessment 

Procedures 

manufacturer 

Annex VII 

notified body 

sterile or with 

a measuring function: 

Annex V 

Annex VII + 

Annex 

IV, V or VI 

Annex II 

without design examination 

or 

Ann. III + Ann. IV, V or VI 

Ann. II with 

design examination 

Ann. III + 

Ann. IV or V

Conformity Assessment 

Procedures 

Technical Documentation 

I I* IIa IIb III IIa IIb III 

Annex VII 

EC- 

Declaration 

of 

Conformity 

Annex III 

EC - Type Examination 

Annex II 

Full Quality 

Assurance 

- ISO 13485 

Annex II 

Full Quality 

Assurance 

+ Design 

Examination 

I 

I* IIa IIb 

Annex IV 

I* IIa IIb III I* IIa IIb 

Annex V 

Annex VI 

- ISO 13485 

- Design 

Dossier 

Examination 

EC-Verification 

- each device 

- samples 

QA Production 

- ISO 13485 

QA Product 

- ISO 13485 

CE 

CE + Number of Notified Body

Conformity Assessment: Type 

Examination & Verification 

• EC-Type Examination* 

– Notified Body examines technical documentation 

and performs tests on a prototype to ensure 

conformity with essential requirements 

• EC – Verification* 

– Notified Body performs tests on every device or 

samples from current production to ensure 

conformity with technical documentation and 

essential requirements 

• * Not popular routes

Conformity Assessment: Quality 

Assurance 

• Notified Body performs audit of the 

manufacturer‘s quality assurance system 

• QA-system in accordance with ISO 13485 

(requirements for medical devices). (ISO 9001 

(general QA) is optional and not advisable) 

ISO 9001 

ISO 13485 

Not required 

for Medical 

Devices 

Specific 

requirements 

(Recommended) 

S19

Conformity Assessment: Steps to 

CE-Marking 

• Define intended use of the device 

• Classify the device 

• Choose a conformity assessment 

procedure 

• Set up and maintain the technical 

documentation including risk 

analysis 

• Perform conformity assessment (if 

required with Notified Body) 

• Issue the declaration of conformity 

and affix the CE marking

20 

Role of the Manufacturer 

• The manufacturer has total responsibility for 

ensuring product complies with Medical 

Device Directives before CE-marking it and 

placing it on the market 

• The manufacturer signs a Declaration of 

Conformity when: 

– Satisfied that the product meets Directives’ 

requirements 

– Necessary conformity assessments are complete 

20

Manufacturer: Product to CE mark 

Confirm the product is a medical device 

Establish the classification 

Choose conformity assessment route 

Prepare 

Quality Management System 


Draft Declaration of Conformity 

Conformity assessment 

Receive Certificate 

Sign Declaration of Conformity 

Apply CE Mark 

21





Prepare 







Apply CE Mark 

• Use in-house or consultant regulatory expertise 

• Discuss with Notified Bodies 

• Discuss with Competent Authorities if necessary 

• Select Notified Body 

• Conduct Clinical Strategy Review 

• Classification guidance in MEDDEV 2.4/1 rev 9 

• http://ec.europa.eu/consumers/sectors/medical 

-devices/documents/guidelines/index_en.htm 

• Conformity Assessment Routes 

• MDD/IVD Annex III Type examination 

• MDD/AIMD Annex II Full Quality System 

• MDD Annex V Production Quality System 

• MDD Annex IV EC Verification 

• MDD Annex VI Product Quality System 

• Prepare Regulatory Roadmap 

• Clinical Evaluation Plan 

• Parallel consultations? 

• Drug, Human Blood derivative, Animal 

Tissue 

• Realistic Timelines 

22





Prepare 






• Core evidence of compliance with EU Directive 

• Required for all devices, all classes 

• Class III devices require “Design Dossier” 

• Focuses on design and demonstrating 

compliance with the Essential Requirements 

• Documentation covers the design, manufacture and 

intended use of the product 

• Must allow assessment of the conformity of the 

product with the requirements of the Directive 

• Address all Essential Requirements 

• Justify “Not Applicables” 



Apply CE Mark 

23





Prepare 







Apply CE Mark 

Contents of a Design Dossier 

• Executive summary 

• General description of the product 

• Including a summary of how the device works 

• Drawings 

• Including a materials list 

• Product Specification 

• Including acceptance criteria and test method 

for verification or validation. 

• Up to Date Risk Analysis and Risk Management 

Report 

• Standards List A few words about standards 

• Process flowchart 

• Design Verification and Validation Data 

• With justification of sample sizes 

• Labelling and Instructions for Use 

• Product lifetime and shelf life 

• Integrity and shelf life of Packaging 

• Biocompatibility and Sterilization information 

• Clinical Evidence 

24

Use of Standards 

2 

5 

• Manufacturer must identify standards used to 

demonstrate conformity with particular essential 

requirements 

• Harmonised Standards give presumption of conformity 

with Essential Requirements of Safety and 

Performance 

• All Harmonised Standards published on EU web site 

– Dates of publication in OJ 

– Dates of cessation of presumption of conformity 

– http://ec.europa.eu/enterprise/policies/europeanstandards/documents/harmonised-standardslegislation/list-references/medical-devices/index_en.htm 

• Horizontal and Vertical Standards

Horizontal Harmonised Standards 

apply across device classes 

EN ISO 13485:2003 

EN ISO 14971:2009 

EN ISO 10993 

Medical devices - Quality management systems - Requirements for 

regulatory purposes 

Medical devices - Application of risk management to medical devices 

various parts relating to Biological evaluation of medical devices 

(biocompatibility, toxicity…) 

EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: 

General requirements 

EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: 

Clinical investigation plans 

EN 980:2008 

EN 1041:2008 

EN ISO 22442-1:2007 

Symbols for use in the labelling of medical devices 

Information supplied by the manufacturer of medical devices 

Various parts relating to medical devices utilizing animal tissues and 

their derivatives 

26

Relationship between Standard 

and Directive 

BS EN ISO 22442-1:2007 relating to medical devices 

utilizing animal tissues and their derivatives

Vertical Harmonised Standards 

• Relate to specific types of device 

• All Harmonised Standards published on EU 

web site 

– Dates of publication in OJ 

– Dates of cessation of presumption of conformity 

– http://ec.europa.eu/enterprise/policies/europeanstandards/documents/harmonised-standardslegislation/list-references/medicaldevices/index_en.htm 

28



(relate to specific device types) 

First 

publication 

OJ 

Reference of 

superseded 

standard 

Date of 

cessation of 

presumption of 

conformity of 

superseded 

standard 

EN ISO 15883-1:2009 

Washer-disinfectors - Part 1: General requirements, 

terms and definitions and tests (ISO 15883-1:2006) 

02/12/2009 EN ISO 15883- 

1:2006 

21/03/2010 

EN ISO 15883-2:2009 

02/12/2009 EN ISO 15883- 

21/03/2010 

Washer-disinfectors - Part 2: Requirements and tests for 

2:2006 

washer-disinfectors employing thermal disinfection for 

surgical instruments, anaesthetic equipment, bowls, 

dishes, receivers, utensils, glassware, etc. (ISO 15883- 

2:2006) 

EN ISO 15883-3:2009 


washer-disinfectors employing thermal disinfection for 

human waste containers (ISO 15883-3:2006) 

EN ISO 15883-4:2009 


washer-disinfectors employing chemical disinfection for 

thermolabile endoscopes (ISO 15883-4:2008) 

02/12/2009 EN ISO 15883- 

3:2006 

02/12/2009 EN ISO 15883- 

4:2008 

21/03/2010 

21/03/2010 

29





Prepare 





• Establish that the product meets the essential 

requirements of directives 



Apply CE Mark 

30


Notified Body Involvement 

The higher the risk of the device, the more 

the Notified Body has to be involved 

Design Dossier Review 

Technical File Review 

Annex II design output 

Technical File review 

Annex II design output; Annex V no design output 

QMS Assessment 

Sterility & Metrology Technical Review 

QMS Assessment 

Medical Device NB 

Class III 

Class IIb 

Class IIa 

Class I 

ISO 13485 

31

Guidance and Recommendations 

• Working Groups and Task Forces 

– http://ec.europa.eu/consumers/sectors/medicaldevices/dialogue-parties/workinggroups/index_en.htm 

• Medical Devices Expert Group (MDEG) 

– MEDDEV Guidance 

• NB-MED 

– NB Recommendations 

• NBOG 

– NBOG Guidance

Medical Devices Expert Group 

(MDEG) 

• Umbrella group for other working groups in 

the field 

– Co-ordinates and oversees their activities 

• Chaired by Commission 

• Member States, Industry and other 

stakeholder representatives 

– Also meets in closed sessions including 

Competent Authorities only

Guidance MEDDEVs 

• http://ec.europa.eu/consumers/sectors/medicaldevices/documents/guidelines/index_en.htm 

• Guidelines that promote a common approach 

– manufacturers and Notified Bodies involved in the 

conformity assessment procedures according to the 

relevant annexes of the Directives 

– Competent Authorities charged with safeguarding Public 

Health 

• Reflect consensus of those in Medical Devices Sector 

– Competent Authorities 

– Commission Services 

– Notified Bodies 

– Industry and other interested parties

MEDDEVs 

2.1 Scope, field of application, definition 

2.2 Essential requirements 

2.4 Classification of Medical Devices 

2.5 Conformity assessment procedure 

– General rules 

– Conformity assessment for particular groups of products 

2.7 Clinical investigation, clinical evaluation 

2.10 Notified bodies 

2.11 Products using materials of biological origin 

2.12 Market surveillance 

2.13 Transitional period 

2.14 IVD 

2.15 Other guidance

NB-MED 

• Chaired by Notified Bodies 

• Terms of Reference 

– Share experience and exchange views on application of 

conformity assessment procedures with the aim of contributing to 

a better understanding and consistent application of 

requirements and procedures 

– Draft technical recommendations on matters relating to 

conformity assessment and build a consensus 

– Advise the Commission on subjects related to application of the 

medical device directives 

– Consider, and if necessary, draft reports on ethical aspects of 

notified bodies’ activities 

– Ensure consistency with standardization work at European level 

– Keep informed of harmonisation activities at European level

NB Recommendations 

• http://www.team-nb.org/documents.htm 

• NB-MED/2.1/Rec1 Representative Sample 

• NB-MED/2.1/Rec2 Explanation of Terms 

• NB-MED/2.1/Rec3 Accessories and other parts for Active Implantable Medical Devices 

• NB-MED/2.1/Rec4 Medical devices with a measuring function 

• NB-MED/2.1/Rec5 Placing on the market of fully refurbished medical devices 

• NB-MED/2.2/Rec1 EMC requirements 

• NB-MED/2.2/Rec2 Treatment of computer used to program Active Implantable Medical Devices (AIMD) 

• NB-MED/2.2/Rec3 "Use-by" date for Medical Devices 

• NB-MED/2.2/Rec4 Software and MEdical Devices 

• NB-MED/2.5.1/Rec4 Content of mandatory certificates 

• NB-MED/2.5.1/Rec5 Technical Documentation 

• NB-MED/2.5.1/Rec6 Renewal of EC Design-Examination and Type-Examination Certificates 

• NB-MED/2.5.2/Rec1 Subcontracting - QS related 

• NB-MED/2.5.2/Rec2 Reporting of design changes and changes of the quality system 

• NB-MED/2.5.2/Rec3 Translation procedure 

• NB-MED/2.5.4/Rec1 Homogeneous batches 

• NB-MED/2.5.4/Rec2 Verification of Manufactured Products for the IVD Directive 

• NB-MED/2.5.5/Rec1 Conformity assessment procedures of breast implants 

• NB-MED/2.5.5/Rec2 Combination of CE-marked and non-CE-marked medical devices and non-medical devices 

• NB-MED/2.5.5/Rec3 Conformity Assessment of Annex II, IVD's designed and evaluated prior to adoption of Common Technical 

Specifications (CTS) 

• NB-MED/2.5.5/Rec4 Assessment of the sensitivity of In Vitro Diagnostic Medical Devices - guidance on the application of the CTS 

• NB-MED/2.7/Rec1 Guidance on clinicals 

• NB-MED/2.7/Rec3 Evaluation of clinical data 

• NB-MED/2.12/Rec1 Post-Marketing Surveillance (PMS) post market/production 

• NB-MED/2.13/Rec1 CE-Marking of pre-MDD devices 

• NB-MED/2.13/Rec2 CE-Marking of established IVD devices 

• NB-MED/2.15/Rec1 Voluntary certification at an intermediate stage of manufacture

Example recommendation 

http://www.team-nb.org/Documents/R2_5_1-6_rev4.pdf

NB-MED/2.5.1/Rec6 Renewal of EC Design-Examination 

and Type-Examination Certificates 

• The purpose of this Recommendation is to describe the 

procedure for renewal of EC Design-Examination Certificates 

or Type-Examination Certificates, so as to avoid the following 

extremes: 

– automatic renewal 

– repeating the complete previous product assessment without 

due recognition of previous Notified Body approvals (both 

original and for substantial changes). 

• Contents 

– Introduction 

– Scope 

– Purpose 

– Renewal Procedure 

– Rationale and History Sheet

Notified Body Operations Group 

(NBOG) 

• http://www.nbog.eu/ 

• Terms of Reference: 

– To improve the overall performance of Notified 

Bodies in the medical devices sector by primarily 

identifying and promulgating examples of best 

practice to be adopted by both Notified Bodies 

and those organisations responsible for their 

designation and control 

• Membership 

– European Commission 

– Member States’ Designating/Competent 

Authorities

NBOG Activities 

• Training for Designating Authority assessors 

• Peer Review of the work of DAs: 

– identify examples of good performance and 

practice 

– confirm consistency of approach in the 

designation and control of NBs 

– detect common problems and shortcomings 

– facilitate transfer of skills between Member States 

– promote best practice between Member States 

– enhance confidence amongst stakeholders 

• Endorsed documents

NBOG Documents 

• Designating Authorities Handbook 

• Best Practice Guides 

– Change of Notified Body 

– Guidance on Design-Dossier Examination and Report Content 

– Role of Notified Bodies in the Medical Device Vigilance System 

– Guideline for Designating Authorities to Define the Notification Scope of a Notified Body Conducting 

Medical Devices Assessment 

– Guidance on Notified Body‘s Tasks of Technical Documentation Assessment on a Representative 

Basis 

– Guidance for Notified Bodies auditing suppliers to medical device manufacturers 

– Guidance on Audit Report Content 

– Certificates issued by Notified Bodies with reference to Council Directives 93/42/EEC, 98/79/EC, 

and 90/385/EEC 

• Checklists 

– Checklist for audit of Notified Body’s review of Clinical Data/Clinical Evaluation 

• Forms 

– Notification form – Directive 93/42/EEC 

– Notification form – Directive 90/385/EEC 

– Notification form – Directive 98/79/EC 

– Certificate Notification to the Commission and other Member States





Prepare 







• Surveillance continues............ 

Apply CE Mark 

43

Renewals: Addressing New 

Regulatory Hurdles 

Five year cycle 

Now 

Updated Legislation 

Updated MEDDEV Documents 

New Harmonised Standards 

State of the Art 

Then 

44

We have covered 

• The roles and interactions of Notified 

Bodies 

• Conformity Assessment 

• Quality Systems 

• Regulatory Working Groups and Task 

Forces 

• Sources of Guidance

Summary of 

recommended references 

• Notified Bodies 

– http://www.mhra.gov.uk/Howweregulate/Devices/NotifiedBodies/UKNotifiedBodiesundertheMedical 

DevicesDirectives/index.htm 

– http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.main 

• Classification guidance in MEDDEV 2.4/1 rev 9 

– http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines/index_en.htm 

• Harmonised Standards 

– http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standardslegislation/list-references/medical-devices/index_en.htm 

• Working Groups and Task Forces 

– http://ec.europa.eu/consumers/sectors/medical-devices/dialogue-parties/workinggroups/index_en.htm 

• Guidance Documents: MEDDEVs 

– http://ec.europa.eu/consumers/sectors/medical-devices/documents/guidelines/index_en.htm 

• NB Recommendations 

– http://www.team-nb.org/documents.htm 

• NBOG 

– http://www.nbog.eu/

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