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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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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.
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:
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
Before 28 February 2022: Member € 710 | Nonmember €835
After 28 February 2022: March 2022: Member € 835 | Nonmember € 990
Upon completion of this session, participants should be able to:
Day One – 23 March 2022: The basics of the IVDR
Welcome and Introductions
RAPS / Alex Laan
How to get started with the IVDR
Alex Laan, NAMSA
Classification and Conformity Routes
Performance Evaluation and Clinical Evidence requirements for IVDs under the IVDR, including Companion Diagnostics
Ciara Airey, GSK
Discussion Q+AFinal Wrap-Up
Close for the Day
24 March : Deep dive on the topics covered yesterday
Performance Evaluation for IVD’s
Ciara Airey, GSK Elizabeth Harrison, BSI
Defining a strategy for Regulatory Compliance for the IVDR
30 March: The basics of the IVDR
Recap previous days Q& A
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
Application Process, manufacturers perspective, with focus points;
Technical Documentation in accordance to the IVDR, including STED, PMS documentation and GSPR
Kira Meyerovich, BDAlex Laan, NAMSA
31 March: Deep dive on the topics covered the previous day
QMS in accordance to the IVDR:
Simon Richards (Abbot Diagnostics and Erica Conway / Elizabeth Harrison BSI / Lessons learned
Technical Documentation build-up of the IVDR
Kira Meyerovich, BDErica Conway / Elizabeth Harrison, BSI
Final Wrap-Up Fiscussion Q+A
Principal Consultant Regulatory IVD
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.
Global Head - In Vitro Diagnostic Medical Devices
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..
Head of Regulatory
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.
Manager RA Advocacy EMEA
Kira Meyerovich is the Manager RA Advocacy EMEA at BD
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..
Technical Team Manager - In Vitro Diagnostic, Regulatory Services
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.
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 firstname.lastname@example.org.