reporting changes to the notified body - bsi group · • change of supplier for eto sterilisation...

Copyright © 2015 BSI. All rights reserved.

Reporting Changes to the Notified Body

Vicky Medley - Head of QMS, Medical Devices November 2015

2 Copyright © 2015 BSI. All rights reserved. Copyright © 2015 BSI. All rights reserved.

1) Requirements & Guidance 2) Reporting Changes - What, When, Why & How 3) Some examples 4) Summary & Questions

3 Copyright © 2015 BSI. All rights reserved.

Requirements of the Medical Directives on Reporting Changes


Medical Devices Directives

• Medical Devices Directive (MDD) 93/42/EEC

• Active Implantable Medical Devices (AIMD) 90/385/EEC

• In Vitro Diagnostics Directive (IVD) 98/79/EC


MDD 93/42/EEC

Quality System

Annex II Section 3

The manufacturer must inform the notified body… of

any plan for substantial changes to the quality system or the product-range covered. The notified body must assess

the changes proposed…

Annex V & VI Section 3

The manufacturer must inform the notified body

which approved the quality system of any plan for

substantial changes to the quality system. The notified

body must assess the changes proposed…

Product

Annex II Section 4

Changes to the approved design must receive further

approval… wherever the change could affect

conformity with the essential requirements of the Directive

or with the conditions prescribed for use of the

product.

Annex III

The applicant shall inform the notified body which issued the

EC type examination certificate of any modification

made to the approved product.


IVDD 98/79/EC

Quality System

Annex IV Section 3

The manufacturer must inform the notified body… of

any plan for substantial changes to the quality system or the product-range covered.

Annex VII Section 3

The manufacturer must inform the notified body

which approved the quality system of any plan for

substantial changes to the quality system.

Product

Ann III Sec 6 Ann IV Sec 4.4

Changes to the approved design must receive further

approval… wherever the change could affect

conformity with the essential requirements of the Directive

or with the conditions prescribed for use of the

product.

Annex V Section 6

Changes to the approved device must receive further …

wherever the changes may affect conformity with the

essential requirements of the Directive or with the

conditions prescribed for use of the device.


AIMD 90/385/EEC

Quality System

Annex 2 Section 3

The manufacturer shall inform the notified body… of any

plan to alter the quality system

Annex 5 Section 3

The manufacturer shall inform the notified body which has approved the quality system

of any plan to alter that system

Product

Annex 2 Section 4

…shall inform the notified body… of any modification

made to the approved design. …must obtain supplementary

approval where such modifications may affect

conformity with the essential requirements… or the

conditions prescribed for the use of the product.

Annex 3

The applicant shall inform the notified body which issued the

EC type examination certificate of any modification

made to the approved product.


To determine whether a change is reportable to the Notified Body we need to know

1. Which directive? (MDD / AIMD / IVDD)

2. Which Annex / Conformity Assessment Route?

3. Whether certified via a Quality System Annex / Certificate or a Product Annex / Certificate?


The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system or the product-range covered. The notified body must assess the changes proposed…

Quality System Annexes

Directive Requirements


Changes to the approved design must receive further approval from the notified body… wherever the change could affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the product

Product Annexes

Directive Requirements


Guidance – NBOG 2014-3

08/12/2015


Guidance – NBOG 2014-3

• Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System

• Published November 2014

• http://www.nbog.eu/

• Includes:

• Requirements on reporting changes

• Roles and responsibilities

• Examples of changes

http://www.nbog.eu/

http://www.nbog.eu/


Reporting Changes - What, When, Why & How


The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system or the product-range covered. The notified body must assess the changes proposed…

Quality System Annexes

What & When?


Changes to the approved design must receive further approval from the notified body… wherever the change could affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the product

Product Annexes

What & When?


Why?

The Notified Body has to

• Decide whether the changed quality system still fulfils the requirements

• Determine and assess whether changes to the quality system could affect the fulfilment of Essential Requirements

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Why?

The Notified Body has to determine appropriate action including:

• Contract review / Update (as needed)

• Assessment of the product design dossier

• Assessment of the quality system or special audit

• Update / Reissue of the EC certificate

• Items / implementation for verification at next audit

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How? NBOG Guidance – 2014

Clause 3 & 4:

• Steps for Manufacturer to assess change

• Steps for the Notified Body to assess change

Clause 5.4 – Particular Examples:

• Design

• Built-in control mechanism

• Operating principles

• Design specifications

• Software

• Materials

• Labelling

• Manufacturing processes, facilities or equipment

• Sterilisation

BSI Form – MDD/AIMD or IVD


Examples


Change No.1

Device • Resorbable bone graft substitute

Directive & Classification • MDD – Class III

Certificate Type • Annex V – Production Quality Assurance Certificate • Annex III – Type Examination Certificate

Change • The device is indicated for void filling in the extremities. The manufacturer would like to expand the indications to the spine.

Does the change need to be reported to the Notified Body?

• Yes or No?


Device • Resorbable bone graft substitute


Certificate Type • Annex V – Production Quality Assurance Certificate • Annex III – Type Examination Certificate

Change • The device is indicated for void filling in the extremities. The manufacturer would like to expand the indications to the spine.


• Yes – impact on Product Certificate

• BSI Product Specialist review including clinical evaluation, risk management and PMS. Reissue of certificate.

Change No.1 - ANSWER


Change No. 2

Device • Daily Wear Contact Lens

Directive & Classification

• MDD - Class IIa

Certificate Type • Annex V - Production Quality Assurance Certificate

Change • Change to the packaging materials


• Yes or No?


Change No. 2 - ANSWER

Device • Daily Wear Contact Lens


• MDD - Class IIa

Certificate Type • Annex V - Production Quality Assurance Certificate

Change • Change to the packaging materials


• No – as no substantial change to the QMS

• Assumes not a new packaging process

• Change / control may be sampled in next assessment


Change No.3

Device • Left ventricular assist mobile power supply unit

Directive & Classification • AIMD (all equivalent to MDD Class III)

Certificate Type • Annex 2.3 - Full Quality Assurance Certificate • Annex 2.4 - Design Examination Product Certificate

Change • 22 software bug fixes including some related to battery life and motor control


• Yes or No?



Device • Left ventricular assist mobile power supply unit

Directive & Classification • AIMD (all equivalent to MDD Class III)

Certificate Type • Annex 2.3 - Full Quality Assurance Certificate • Annex 2.4 - Design Examination Product Certificate

Change • 22 software bug fixes including some related to battery life and motor control


• Yes – impacts on product certificate. • Changes will be reviewed by AIMD expert and design

Examination Certificate re-issued with history page updated to reflect the change was reviewed.


Change No.4

Device • Spirometer

Directive & Classification • MDD – Class IIa

Certificate Type • Annex II.3 - Full Quality Assurance Certificate

Change • Change of address of legal manufacturer. • Legal manufacturer is virtual and all production

sub-contracted.


• Yes or No?



Device • Spirometer

Directive & Classification • MDD – Class IIa

Certificate Type • Annex II.3 - Full Quality Assurance Certificate

Change • Change of address of legal manufacturer. • Legal manufacturer is virtual and all production

sub-contracted.


• Yes. Certificate requires update to reflect the new address.

• Verification at next onsite QMS visit - product labels, contracts, complaints forwarding (from old address). Plus any other changes to responsibilities / activities etc.


Change No.5

Device • Solutions for storage and transportation of organs


Certificate Type • Annex II.3 - Full Quality Assurance Certificate • Annex II.4 - Design Examination Certificate

Change • Solution manufacturing to be moved new onsite location (aseptic filling), rather than using a subcontractor


• Yes or No?



Device • Solutions for storage and transportation of organs


Certificate Type • Annex II.3 - Full Quality Assurance Certificate • Annex II.4 - Design Examination Certificate

Change • Solution manufacturing to be moved in-house (aseptic filling), rather than using a subcontractor


• Yes – Impacts both product and quality system certificates & both require reissue

• Onsite audits required of both QMS and Microbiology & Sterilisation audit of new aseptic process

• Product – review by Product Specialist and Medicinal Substance Experts


Change No.6

Device • Surgical sutures (non-resorbable)


• MDD – Class IIb

Certificate Type • Annex II.3 - Full Quality Assurance – Quality System Certificate

Change • Change of supplier for ETO sterilisation service


• Yes or No?



Device • Surgical sutures (non-resorbable)


• MDD – Class IIb


Change • Change of supplier for ETO sterilisation service


• Yes • No direct review required, but • Critical Subcontractors listed on BSI EC Certificate • Need to update Unannounced Audit plan • Certificate could be updated at next reissue


Change No.7

Device • Dental Instrumentation


• MDD – Class IIa


Change • Change of European Authorised Representative for a US based manufacturer


• Yes or No?



Device • Dental Instrumentation


• MDD – Class IIa

Certificate Type • Annex II.3 - Full Quality Assurance – Quality System certificate

Change • Change of European Authorised Representative for a US based manufacturer


• Yes • Review of labels, IFU, declaration of

conformity. • Verification of labels, contract, vigilance

handling at next onsite surveillance visit • Reissue of certificate listing new Authorised

Representative


Change No.8

Device • Vascular Stent


Certificate Type • Full Quality Assurance – Quality System certificate • Design Examination – Product Certificate

Change • Change to IFU layout and colours due to company re-branding

• Change to manufacturing setting to operate at a tighter target range / tolerance within the existing specification


• Yes or No?



Device • Vascular Stent


Certificate Type • Full Quality Assurance – Quality System certificate • Design Examination – Product Certificate

Change • Change to IFU layout and colours due to company re-branding

• Change to manufacturing setting to operate at a tighter target range / tolerance within the existing specification


• No

• If no technical change to IFU (colours / layout only) • If no change to manufacturing within existing limits /

specification – no NB review required


Summary

1. Requirement depends on the conformity assessment route / certification held

• Product Certificates – where may affect conformance with Essential Requirements, product range or device safety and performance

• Quality Certificates – Planned substantial changes

2. Changes will be reviewed in (almost) all NB audits, processes for change control are an integral and critical part of any QMS including appropriate control of subcontractors and suppliers


Summary (Continued)

3. It’s always best to be open and communicate with the Notified Body well in advance & especially for complex cases

4. If in doubt or for borderline case, summarise the change planned and if it’s not considered reportable explain why

– the Notified Body will either review and agree and accept or not!


Questions?


Thank you

Name: Vicky Medley

Title: Head of QMS – Medical Devices

Address: BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP, UK

Telephone: +44 (0)1908 814865

Mobile: +44 (0)7717 680688

Email: [email protected]

Links: http://medicaldevices.bsigroup.com/


Additional Information - For Reference Only


References

• Medical Devices Directives

• 90/385/EEC

• 93/42/EEC

• 98/79/EC

• Commission Regulation (EU) No 722/20125

• Commission Recommendation 2013/473/EU of 24.09.2013 on the audits and assessments performed by notified bodies in the field of medical devices

• NBOG 2014-3 Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System

• EN ISO 13485:2012 Medical devices – Quality management systems – Requirements for regulatory purposes


Reference to ‘Changes’ in ISO 13485:2003 & EN ISO 13485:2012 • Changes / changed mentioned 15 times in Clauses 4-8

• See CEN ISO/TR 14969 for further guidance

Clause No. of References

4 – QMS 2

5 – Management 3

6 – Resources 0

7 – Product realisation 10

8 – Improvement 1


Reference to ‘Changes’ in the Medical Directives

• Example - MDD 93/42/EEC Change / changes is mentioned 25 times

• 4 instances related to labelling (Annex I - ER13.6 k) and classification (Annex IX – definitions, Rule 7 and 8) not directly relevant to this presentation

Annex No. of References

I 4

II 7

III 3

V 4

VI 4

IX 3

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