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Rollout IVDR 2022: How to prepare for the IVDR by May 2022. Date of Application or Dead on Arrival?

12.0
RAC Credits
Europe Europe Virtual Programs Virtual Programs
Wednesday, 23 March 2022 (1:00 PM) - Thursday, 31 March 2022 (5:00 PM) Central European Time (CET)

This is a multi-day virtual workshop that will be divided into four separate live sessions.  Sessions will be recorded and available to all registered participants.

  • Part I –  23 March, 2022 – 13:00 CET – 17:30 CET (8:00 AM ET - 12:30 PM ET)
  • Part II - 24 March, 2022 – 13:00 CET – 17:30 CET (8:00 AM ET - 12:30 PM ET)
  • Part III - 30 March, 2022 – 13:00 CET – 17:30 CET (7:00 AM ET - 11:30 AM ET)
  • Part IV - 31 March, 2022 – 13:00 CET – 17:30 CET (7:00 AM ET - 11:30 AM ET)

Please note: due to differing dates for the beginning of daylight savings time in Europe and the US, the third and fourth sessions will be an hour earlier in the US than the first and second.


Complying with the new EU requirements for IVD’s is expected to become very challenging for IVD manufacturers, some say even more than the MDR. The leaving point for many manufacturers is the IVD directive that came into force in the year 2003. In the meantime, much has changed.

As a result of the introduced IVDR, manufacturers that currently place IVD’s on the EU Community market will encounter the new reality; facing scrutiny by EU Notified Bodies and Competent Authorities, installing a Person Responsible for Regulatory Compliance, carrying out additional testing and even performance investigations. For a large portion of the IVD manufacturers, this reality will be apparent as of the date of application - 26 May 2022 - since a large portion of IVD devices will need to comply after that date without the reliance on market access through the current IVDD certificate. Although this date may still seem to be far in the future, there is a lot that IVD manufacturers need to do in order to prepare.

This workshop will cover these big themes of the IVDR with hands-on information on how to tackle the most important requirements. Elements that are going to be covered are:

  • Most important elements of the IVDR and focus areas when implementing
  • Developing a strategy for regulatory compliance in accordance with the IVDR
  • Performance Evaluation process and documentation requirements
  • Reviewing and effectively implementing IVDR requirements into Technical dossiers and QMS
  • Integrating Risk Management and Post Market Surveillance into the QMS
  • Management of the implementation of the IVDR project

The potential impact of the IVDR for new and existing (legacy) devices will be discussed together with important considerations for determining the appropriate regulatory pathway and application strategy

Registration Fees & Deadlines

Before 28 February 2022: Member € 710  | Nonmember €835 

After 28 February 2022: March 2022: Member € 835 | Nonmember € 990 

Objectives

Upon completion of this session, participants should be able to:

  • Understand the most important requirements of the IVDR and how this affects product compliance.
  • Understand how to implement these requirements in your QMS and technical dossier.
  • Develop a good understanding of how to develop a sound regulatory strategy for your device.
  • Understand how to apply with a Notified Body once all the preparations are done.

Agenda

Day One – 23 March 2022: The basics of the IVDR

13:00 (CET)

Welcome and Introductions

RAPS / Alex Laan

13:15

How to get started with the IVDR

  • Key Definition,
  • Intended Purpose
  • Placing on the market, putting into service timelines
  • Economic Operators and the role of the PRRC
  • Transitioning IVDD to IVDR

Alex Laan, NAMSA

14:15

Classification and Conformity Routes

Alex Laan, NAMSA

15:15

Break

 

15:30

Performance Evaluation and Clinical Evidence requirements for IVDs under the IVDR, including Companion Diagnostics

Ciara Airey, GSK

16:30

Discussion Q+A
Final Wrap-Up

Panel

17:00

Close for the Day

All

 

 

 

24 March : Deep dive on the topics covered yesterday

13:00

Performance Evaluation for IVD’s

  • Feasibility of clinical evidence for legacy devices
  • Performance Evaluation Plan
  • Scientific Validity Report
  • Analytical Performance Report
  • Clinical Performance Report
  • Performance Evaluation Report

Ciara Airey, GSK Elizabeth Harrison, BSI

 

14:30

Break

 

14:45

Defining a strategy for Regulatory Compliance for the IVDR

Alex Laan, NAMSA

16:15

Discussion Q+A
Final Wrap-Up

Panel

17:00

Close for the Day

All

 

30 March: The basics of the IVDR

13:00 (CET)

Recap previous days Q& A

 

13:15

The Notified Body process:
Application process (lessons learned – past experience), audits, ISO v IVDR audit, audit subcontractors, unannounced audits, sampling, reference labs, companion diagnostic consultation

Erica Conway / Elizabeth Harrison, BSI

Simon Richards, Abbott Diagnostics

14:15

Application Process, manufacturers perspective, with focus points;

  • Gap / Impact Analysis IVDR
  • QMS Requirements
  • Performance Evaluation Requirements
  • Implementation of changes to the QMS

Simon Richards, Abbott Diagnostics

 

15:15

Break

 

15:30

Technical Documentation in accordance to the IVDR, including STED, PMS documentation and GSPR

Kira Meyerovich, BD
Alex Laan, NAMSA

16:00

Discussion Q+A
Final Wrap-Up

Panel

17:00

Close for the Day

All

 

 

31 March: Deep dive on the topics covered the previous day

13:00

 

QMS in accordance to the IVDR:

  • Regulatory Analysis of IVDR QMS requirements
  • Use of standards in the application (Harmonised vs non-harmonised)
  • Verification of Effectiveness (internal and external audits/ Remote vs onsite)
  • Project Management of the IVDR implementation

Simon Richards (Abbot Diagnostics and Erica Conway / Elizabeth Harrison BSI / Lessons learned

 

14:30

Break

 

14:45pm

Technical Documentation build-up of the IVDR

  • Annex II and Annex III TD requirements
  • GSPR creation, including (non)-applications
  • Application of (harmonized) standards
  • Building a Technical Dossier including PMS Lessons learned (BSI)
  • Project Management of the IVDR implementation

Kira Meyerovich, BD
Erica Conway / Elizabeth Harrison, BSI

 

16:15

Final Wrap-Up
Fiscussion Q+A

Panel

17:00

Close for the Day

All

Workshop Leader:

Alex Laan

Alex Laan

Principal Consultant Regulatory IVD

NAMSA

Alex currently holds the position of Principal Consultant Regulatory IVD at NAMSA. Until recently, Alex worked as Principal Certification Manager at DEKRA Certification BV, Notified Body for (IVD) Medical Devices located in Arnhem, The Netherlands. After starting at KEMA Quality in 2006, Alex was qualified for Lead Assessor for Medical Devices and IVD devices, Device Specialist reviewer in IVD's and Medical Devices, including drug-device combinations. Active member of IVD working group within EU Notified Bodies and TEAM-NB. Acting as direct contact for EU competent authorities. Alex has an education as engineer (Dipl.-Ing) in Bioprocesstechnology and Biochemistry. Previously, Alex worked as a product specialist in immunohematological products and plasma products with Sanquin Blood Transfusion Services, Amsterdam, after which he started his career working as a QA and RA manager for IVD Medical devices at Meddens Diagnostics / IBL Hamburg.

Speakers:

Erica Conway

Erica Conway

Global Head - In Vitro Diagnostic Medical Devices

BSI

Erica has over 15 years experience in the In Vitro Diagnostic (IVD) medical device and pharmaceutical industries, within Regulatory Affairs and Quality Assurance. Following a BSc (Hons), PhD (Neurophysiology) and Post-doctural research, Erica’s industrial experience started at GlaxoSmithKline in the regulation of pharmaceuticals. Further she worked in the arena of clinical trials for medicinal products for Quintiles. Erica then moved into the field of IVD medical devices when she became the Regulatory Affairs Manager for Axis-Shield Diagnostics (Alere Toxicology, now Abbott). She then went into performing independent consultancy work and continued working within the IVD and medical device field, as a continued member of British IVD Association, prior to joining BSI. Erica joined BSI at the beginning of 2014 as a Technical Specialist/Scheme Manager in the IVD medical devices team. She took the position of Global Head of the IVD Medical Device Team June 2016, to lead the IVD Technical team. Erica is currently using her experience to transition the Notified Body (NB) to the new EU IVD Regulation and expand the technical team for the increased demands of the NB under the IVDR. She is a co-chair of the IVD NB working group for NB-Med/Team-NB..

Ciara Airey

Ciara Airey

Head of Regulatory

Inivata

Ciara Airey has over a decade of experience in the In Vitro Diagnostic (IVD) medical device industry within R&D and Regulatory Affairs. Ciara’s industrial experience started at QIAGEN in the development and regulation of companion diagnostic assays where she played an integral role in the registration/approval of companion diagnostics in the US and EMEA. From there she moved into regulatory consulting and writing for the CRO, NAMSA, where she continued to work with global customers in the IVD field, focusing primarily on IVDR compliance. Ciara also had the wonderful opportunity to work on the pharma side of precision medicine at GlaxoSmithKline before moving back to diagnostics and is currently Head of Regulatory at Inivata. Ciara holds a Ph.D. and research masters degree in molecular and cellular biology from the University of Liverpool, a postgraduate diploma in statistics, and a batchelors degree in human genetics from Trinity College Dublin.

Leslie Cort, RAC, PMP

Kira Meyerovich

Manager RA Advocacy EMEA

BD

Kira Meyerovich is the Manager RA Advocacy EMEA at BD

Simon Richards

Vice President Divisional Regulatory Affairs

Abbott Rapid Diagnostics

Simon Richards is VP, Divisional Regulatory Affairs for Abbott Rapid Diagnostics Originally a Ph.D Biochemist, he has worked in the Vaccines and Diagnostics industry for over 27 years. He is the former Chairman of the UK IVD Industry body, BIVDA and part of the key stakeholder team interacting with MHRA on the implementation of the IVD Regulations in the UK. Simon is the IVDR project lead for the Abbott Rapid Diagnostics Division which includes the largest range of Near Patient tests in the world and covers devices in all the new risk categories and in sites spread across the world..

Elizabeth Harrison

Technical Team Manager - In Vitro Diagnostic, Regulatory Services

BSI

Dr Liz Harrison, IVD Technical Team Manager at BSI, has responsibility for CE Marking and ISO 13485 activities for clients worldwide. Before joining BSI, she held senior and principle scientist roles in design and development of NAT diagnostic platforms for near-patient testing of sepsis, respiratory infections, genetic disease, cancer and companion diagnostics. She also spent time as a post-doctoral scientist in the School of Translational Medicine at the University of Manchester investigating rapid diagnostics for sepsis and respiratory disease. Liz holds a BSc (Hons) in Biochemistry from UMIST, Manchester and a PhD in molecular diagnostics from the University of Bath.

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. Substitutions may be accepted with written approval from RAPS and must be submitted to support@raps.org.