reporting changes to your notified body - bsi ... - bsi group · pdf filereporting changes to...
TRANSCRIPT
Copyright © 2015 BSI. All rights reserved.
Reporting Changes to your Notified Body
Vicky Medley - Head of QMS, Medical Devices September 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
4 Copyright © 2015 BSI. All rights reserved.
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
5 Copyright © 2015 BSI. All rights reserved.
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.
6 Copyright © 2015 BSI. All rights reserved.
IVDD 98/789/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.
7 Copyright © 2015 BSI. All rights reserved.
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.
8 Copyright © 2015 BSI. All rights reserved.
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?
9 Copyright © 2015 BSI. All rights reserved.
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
10 Copyright © 2015 BSI. All rights reserved.
Changes to the approved design must receive further approval from the notified body… wherever the change could affect conformity w ith the essential requirements of the Directive or with the conditions prescribed for use of the product
Product Annexes
Directive Requirements
12 Copyright © 2015 BSI. All rights reserved.
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
14 Copyright © 2015 BSI. All rights reserved.
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?
15 Copyright © 2015 BSI. All rights reserved.
Changes to the approved design must receive further approval from the notified body… wherever the change could affect conformity w ith the essential requirements of the Directive or with the conditions prescribed for use of the product
Product Annexes
What & When?
16 Copyright © 2015 BSI. All rights reserved.
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
17 Copyright © 2015 BSI. All rights reserved.
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
18 Copyright © 2015 BSI. All rights reserved.
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
20 Copyright © 2015 BSI. All rights reserved.
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?
21 Copyright © 2015 BSI. All rights reserved.
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 – impact on Product Certificate
• BSI Product Specialist review including clinical evaluation, risk management and PMS. Reissue of certificate.
Change No.1 - ANSWER
22 Copyright © 2015 BSI. All rights reserved.
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
Does the change need to be reported to the Notified Body?
• Yes or No?
23 Copyright © 2015 BSI. All rights reserved.
Change No. 2 - ANSWER
Device • Daily Wear Contact Lens
Directive & Classification
• MDD - Class IIa
Certificate Type • Annex V - Production Quality Assurance Certificate
Change • Change to the packaging materials
Does the change need to be reported to the Notified Body?
• No – as no substantial change to the QMS
• Assumes not a new packaging process
• Change / control may be sampled in next assessment
24 Copyright © 2015 BSI. All rights reserved.
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
Does the change need to be reported to the Notified Body?
• Yes or No?
25 Copyright © 2015 BSI. All rights reserved.
Change No.3 - ANSWER
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
Does the change need to be reported to the Notified Body?
• 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.
26 Copyright © 2015 BSI. All rights reserved.
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.
Does the change need to be reported to the Notified Body?
• Yes or No?
27 Copyright © 2015 BSI. All rights reserved.
Change No.4 - ANSWER
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.
Does the change need to be reported to the Notified Body?
• 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.
28 Copyright © 2015 BSI. All rights reserved.
Change No.5
Device • Solutions for storage and transportation of organs
Directive & Classification • MDD – Class III
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
Does the change need to be reported to the Notified Body?
• Yes or No?
29 Copyright © 2015 BSI. All rights reserved.
Change No.5 - ANSWER
Device • Solutions for storage and transportation of organs
Directive & Classification • MDD – Class III
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
Does the change need to be reported to the Notified Body?
• 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
30 Copyright © 2015 BSI. All rights reserved.
Change No.6
Device • Dental Instrumentation
Directive & Classification
• 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
Does the change need to be reported to the Notified Body?
• Yes or No?
31 Copyright © 2015 BSI. All rights reserved.
Change No.6 - ANSWER Device • Dental Instrumentation
Directive & Classification
• 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
Does the change need to be reported to the Notified Body?
• 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
32 Copyright © 2015 BSI. All rights reserved.
Change No.7
Device • Vascular Stent
Directive & Classification • MDD – Class III
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
Does the change need to be reported to the Notified Body?
• Yes or No?
33 Copyright © 2015 BSI. All rights reserved.
Change No.7 - ANSWER
Device • Vascular Stent
Directive & Classification • MDD – Class III
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
Does the change need to be reported to the Notified Body?
• No
• If no technical change to IFU (colours / layout only) • If no change to manufacturing within existing limits /
specification – no NB review required
34 Copyright © 2015 BSI. All rights reserved.
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
35 Copyright © 2015 BSI. All rights reserved.
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!
37 Copyright © 2015 BSI. All rights reserved.
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/
39 Copyright © 2015 BSI. All rights reserved. Copyright © 2015 BSI. All rights reserved.
Additional Information - For Reference Only
40 Copyright © 2015 BSI. All rights reserved.
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
41 Copyright © 2015 BSI. All rights reserved.
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
42 Copyright © 2015 BSI. All rights reserved.
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