bsi ivdr webinar initial lessons learned and preparing a
TRANSCRIPT
Copyright © 2019 BSI. All rights reserved
1Copyright © 2020 BSI. All rights reserved
Erica Conway and Todd Moorman
17 June 2020
Copyright © 2020 BSI. All rights reserved
BSI IVDR WebinarInitial Lessons Learned and Preparing a Successful IVDR Application
Copyright © 2019 BSI. All rights reserved
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Dr Erica ConwayGlobal Head – IVD Technical TeamRegulatory Services (Medical Devices)
Todd MoormanVP, IVD Sales Solutions in the AmericasRegulatory Services (Medical Devices)
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Impact of the IVDR
Medical information from a human sample
Any human sample Blood groupingBacteria
Viruses
Cancer
Genetic risksBiochemistry
Self-tests
Scope & Definitions
Interventional Studies
Making available, putting into service
Obligations of Economic Operators
Person Responsible for Regulatory Compliance
UDI and Registration
Electronic systems (Eudamed)
Summary of Safety and Performance
Notified BodiesClassification & Conformity Assessment
Reference LaboratoriesCommon Specifications
Medical Devices Coordination Group (MDCG)
Scrutiny of Class D devicesClinical Evidence &
Performance Evaluation
Post-market performance follow-up
Performance study applications; Sponsor & Database
Post-market surveillanceVigilance
IVDR
EU 2017-746
Re-classification of IVDs will mean 80-90 %
devices will no longer be able to ‘self certify’
conformity
90% of IVDs will now need
a NB!
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• Information presented is based on our current understanding of the IVDR
• Subject to change!
Disclaimer
Copyright © 2019 BSI. All rights reserved
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Initial Lessons Learned from an IVDR designated NB
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Agenda1. Applications
2. Transitioning your devices Intended Purpose What do we do?
3. Technical Documentation & QMS Audits- lessons learned so far
4. Guidance
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Applications
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Your starting place!• Our Website
• https://www.bsigroup.com/en-GB/medical-devices/• https://www.bsigroup.com/IVDR-Revision/
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CE marking guidehttps://www.bsigroup.com/globalassets/meddev/localfiles/en-
gb/services/bsi-mdr-ivdr-app-and-cert-process-uk-en.pdf
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Application Documentation – Annex IX2. Quality management system assessment2.1. The manufacturer shall lodge an application for assessment of its quality management system with a notified body. The application shall include: • the name of the manufacturer and address of its registered place of business and any
additional manufacturing site covered by the quality management system, and, if the manufacturer's application is lodged by its authorised representative, the name of the authorised representative and the address of the authorised representative's registered place of business,
• all relevant information on the device or group of devices covered by the quality management system,
• a written declaration that no application has been lodged with any other notified body for the same device-related quality management system, or information about any previous application for the same device-related quality management system,
• a draft of an EU declaration of conformity in accordance with Article 17 and Annex IV for the device model covered by the conformity assessment procedure,
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Application Documentation – Annex IXThe application shall include (continued):• a description of the procedures in place to ensure that the
quality management system remains adequate and effective, and the undertaking by the manufacturer to apply those procedures,
• a description of the procedures in place to keep up to date the post-market surveillance system, and, where applicable, the PMPF plan, and the procedures ensuring compliance with the obligations resulting from the provisions on vigilance set out in Articles 82 to 87, as well as the undertaking by the manufacturer to apply those procedures,
• documentation on the performance evaluation plan, and • a description of the procedures in place to keep up to date
the performance evaluation plan, taking into account the state of the art.
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IVDR Certificates – Annex IX Chapter I & III
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Requirements related to Legal Entities• Annex VII 4.8, 9th indent
• Annex XII Chapter I section 3
Legal Manufacturer Principle
• One SRN per legal entity• Distinct UDIs for devices from each
legal entity• One Conformity Assessment
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Mirror certificates + Certificates with multiple namesAm I the same
person if I have a
different SRN?
Separate application required from each Legal Entity
Separate Conformity Assessments
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IVDR Certificates – Annex IX Chapter I & III
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Intended Purpose• Intended Purpose = Intended Use - Annex I part 20.4.1 c
Device's intended purpose: (i) what is detected and/or measured(ii) its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic)(iii) the specific information that is intended to be provided in the context:
a physiological or pathological statecongenital physical or mental impairments the predisposition to a medical condition or a diseasethe determination of the safety and compatibility with potential recipientsthe prediction of treatment response or reactionsthe definition or monitoring of therapeutic measures
(iv)whether it is automated or not(v) whether it is qualitative, semi-quantitative or quantitative(vi) the type of specimen(s) required(vii) where applicable, the testing population(viii) for companion diagnostics, the International Non-proprietary Name (INN) of the associated medicinal product for which it is a companion test
• AIMDD• MDD• IVDD• MDR
• IVDR• Blue Guide 2016• MedDev 2.14/1• MedDev 2.14/2• MedDev 2.14/3• IMDRF N52• ISO 14971:2019• US FDA 21 CFR 801.4
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IVDR Certificates – Annex IX Chapter II
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Certificates issued under Annex IX
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Certificates issued under Annex IX
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Certificates issued under Annex IX
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Transitioning your devices
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• Intended Purpose• Classification
• Information provided for your devices & your QMSS
Your whole scope for QMS auditYour provisional transition
timings of technical documentation submission & IVDR QMS auditurdevices
Key aspects for starting an application
Copyright © 2019 BSI. All rights reserved
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Classification Dispute – Article 47
Classification
Consult Competent Authority (CA) Member State of Manufacturer or EU AR
Inform NB, MDCG and EU Commission of Decision
Consult with NB’s CA
e.g. US company with EU Rep in Ireland
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Application phase - You can help us by…
Provide detailed classification rationales
Provide all the information requested in
the Device Schedule
Complete the Application Document Checklist and
provide supporting documents when returning signed
contracts
Convey the timelines of technical documentation
submissions clearly
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Technical Documentation and QMS Audits – lessons learned so far
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Required Plans1. Strategy for Regulatory Compliance – Article 10 & Annex IX
2. Risk Management Plan – Annex I
3. Performance Evaluation Plan – Annex IX, Annex XIII
4. Clinical Performance Study Plans – Annex XIII, Annex XIV
5. Post Market Surveillance Plan – Annex III
6. Post Market Performance Follow-Up Plan – Annex XIIIDon’t get caught and take “Plan”
too literally
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Strategy for Regulatory ComplianceArticle 10 – General obligations of manufacturers
• The quality management system shall address at least the following: (a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system
Annex IX Section 2.2 (c):
• The strategy for regulatory compliance to include processes for:• Identification of relevant legal requirements• Qualification• Classification• Handling of equivalence• Choice of and compliance with conformity assessment procedures
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IVDR QMS – Tools Developed for BSI Auditors
Audit Plan – EU Regulatory
Requirements
Guidance on Implementation + Examples of Minor
/ Major NCs
Checklist of EU MDR
Requirements
Checklist of EU IVDR
Requirements
*More than Article 10
e.g. what if EUDAMED is not working?
More than ~100 items
Subject to change/redefined as MDCG guidance
published
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IVDR QMS Audits – You can help us byIVDR QMS Audit ISO 13485 Audit
*Risk Management Plan – not covered today
PRRC in place – principles in MDCG 2019-7
Procedures /plans/templates in place even if EU Provisions
(EUDAMED etc) are not readyPlans as required by IVDR in
place
Provisions for UDI in place Vigilance/PMS provisions in place
Provisions in place for monitoring the publication of
guidance documents and plans in place for implementing them
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IVDR Technical assessments• Notified must limit their technical assessments in order to come to
a decision
…//…
…//…
…//…
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Documentation Submissions for IVDR• A complete and well-
organized file decreases time and costs of review
• Reference BSI’s Documentation Submissions Best Practices Guideline
https://www.bsigroup.com/globalassets/localfiles/en-za/iso-13485/ivdr-best-practice-documentation-submissions-sa.pdf
Revised guidance to be published soon
Remember –Searchable, bookmarked
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Technical Documentation Questions – SSP
Please point to the information regarding
previous generations or variants of the device per Article 29, Section 2(c)?
Please provide the procedure and explain the defined frequency and/or what circumstances may
warrant update to the SSP?
How has the manufacturer confirmed that the portions of the SSP intended for self test users can be read and understood by a layperson?
Please address the following inconsistencies
between information in the PEAR, IFU, SSP, and risk
management?
“For Class C&D devices, the PMPF evaluation
report and, if indicated, the summary of safety
and performance referred to in Article 29 shall be updated at least annually with such data.”
SSPs may be required to be submitted (by the time of certification) even for
devices that haven’t been sampled in initial
assessment (awaiting guidance)
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IVDR Technical Documentation – You can help us by..
Refer to Annex II & XIII to make correlation of documents clear
For legacy / established devices, tell a clear story of how testing and performance data support the current version of the device
Include all relevant information in first submission to avoid additional requests
Refer to our Documentation Submission Guideline
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EU Guidance Documents – you need to follow these…Annex VII Section 4.5.1
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EU Guidance Documents – you need to follow these…https://ec.europa.eu/growth/sectors/medical-devices
How often are manufacturers
checking for changed documents and the
impact on processes?
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Preparing a Successful IVDR Application
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Agenda
• Regulatory Requirements• Legal Manufacturer• Notified Body
• IVDR Application Process• Timing of Application• Customer Information Form (CIF)• Device Schedule (DS)• Quote/Contract
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Regulatory Requirements• IVDR Annex IX Requirements to met by the manufacturer
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Regulatory Requirements• IVDR Annex IX Requirements to met by the manufacturer
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Regulatory Requirements• IVDR Annex VII Requirements to met by Notified Bodies
Terms & conditions:Manufacturer obligations!
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Regulatory Requirements
Requirements Annex IX section 2.1 are covered in the contract/quote
Successful Application with us requires to submit all listed QMS documents as per the checklist once the quote/contract is signed and returned!
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Regulatory Requirements• When a manufacturer should start the application process?
• What to consider for a successful application?
May 2022Hard deadline for „legacy devices“
Your QMS is implemented in compliance with IVDR
• In process of QMS implementation
• In process of QMS gap analysis
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Regulatory RequirementsWhat about the Technical Documentation?
• Creation of Technical Files of the respective product portfolio under the IVDR should be finalised or in the final stage
• You schedule your readiness of your Technical Documentation submission
Consider Sampling!NB will select the file per group (Class B, Class C)
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Your responsibility!
You will need to provide your device details
Quote/Contract signed & returned
Provide listed QMS documents
Application will setup in BSI systems
IVDR QMS audit scheduling
TD submission scheduling
IVDR Application Process – Quote/Contract
Dedicated Scheme Manager is assigned to you!
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Even though we are waiting for classification guidance, do not let this stop you from progressing your transition plans
- There is not much difference between Class B & Class C in requirements
- Time is critical!
Classify - If necessary, work on the ‘worst
case’ scenario Work on gap analyses Start interacting with a Notified
Body
What you can do now!
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Scope & device classification
Gap Analyses on
requirementsYour transition
strategy
Keep the deadline in sight!
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bsigroup.com/IVDR-revision
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Download!
bsigroup.com/IVDR-revision
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Interacting with a Notified Body (NB)
You have options!• Manufacturer’s choice for NB
• Important relationshiphttp://ec.europa.eu/growth/tools-databases/nando/
• Check designation plans Are they applying for your IVDR
codes? Designated NBs will be listed
“Regulation (EU) 2017/746”
NB competence is defined by IVDR (NBOG) codes• http://www.doks.nbog.eu/Doks/NBOG_F_2
017_4_IVDR.docx; (EU) 2017-2185
• https://ec.europa.eu/growth/sectors/medical-devices/new-regulations/guidance_en
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Useful links:
• Official EU website with information for IVD Manufacturers:
https://ec.europa.eu/growth/sectors/medical-devices/getting-ready-new-regulations/manufacturers-ivd_en
• Competent Authorities for Medical Devices FAQs site:
https://www.camd-europe.eu/wp-content/uploads/2018/05/FAQ_IVDR_180117_V1.0-1.pdf
• EU factsheet for IVD manufacturers with details of transitional provisions:
https://ec.europa.eu/docsroom/documents/33662/attachments/1/translations/en/renditions/native
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http://medicaldevices.bsigroup.com/www.bsigroup.com/IVDR-revision