Reporting Changes to your Notified Body Vicky Medley - Head of QMS, Medical Devices September 2015
1) Requirements & Guidance 2) Reporting Changes - What, When, Why & How 3) Some examples 4) Summary & Questions 2
Requirements of the Medical Directives on Reporting Changes 3
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 4
MDD 93/42/EEC Quality System Product Annex II Section 3 Annex V & VI Section 3 Annex II Section 4 Annex III 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 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 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. The applicant shall inform the notified body which issued the EC type examination certificate of any modification made to the approved product. 5
IVDD 98/789/EC Quality System Product Annex IV Section 3 Annex VII Section 3 Ann III Sec 6 Ann IV Sec 4.4 Annex V Section 6 The manufacturer must inform the notified body of any plan for substantial changes to the quality system or the product-range covered. The manufacturer must inform the notified body which approved the quality system of any plan for substantial changes to the quality system. 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. 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. 6
AIMD 90/385/EEC Quality System Product Annex 2 Section 3 Annex 5 Section 3 Annex 2 Section 4 Annex 3 The manufacturer shall inform the notified body of any plan to alter the quality system The manufacturer shall inform the notified body which has approved the quality system of any plan to alter that system 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. The applicant shall inform the notified body which issued the EC type examination certificate of any modification made to the approved product. 7
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? 8
Directive Requirements Quality System Annexes 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 9
Directive Requirements Product Annexes 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 10
Guidance NBOG 2014-3 08/12/2015 11
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 12
Reporting Changes - What, When, Why & How 13
What & When? Quality System Annexes 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 14
What & When? Product Annexes 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 15
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 16
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 17
How? NBOG Guidance 2014 Clause 3 & 4: Steps for Manufacturer to assess change Steps for the Notified Body to assess change BSI Form MDD/AIMD or IVD Clause 5.4 Particular Examples: Design Built-in control mechanism Operating principles Design specifications Software Materials Labelling Manufacturing processes, facilities or equipment Sterilisation 18
Examples 19
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? 20
Change No.1 - ANSWER 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. 21
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? 22
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 23
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? 24
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. 25
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? 26
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. 27
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? 28
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 29
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? 30
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 31
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 rebranding 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? 32
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 rebranding 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 33
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 34
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! 35
Questions? 36
Thank you Name: Title: Address: Vicky Medley Head of QMS Medical Devices BSI, Kitemark Court, Davy Avenue, Knowlhill, Milton Keynes MK5 8PP, UK Telephone: +44 (0)1908 814865 Mobile: +44 (0)7717 680688 Email: Links: vicky.medley@bsigroup.com http://medicaldevices.bsigroup.com/ 37
Additional Information - For Reference Only 39
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 40
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 41
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 42