Webinar: IVDR Lessons Learnt

What’s this webinar about?

The In Vitro Diagnostic Regulation (IVDR) date of application is fast approaching. Manufacturers have the transition period's duration to complete their Technical Documentation to meet the requirements and comply with the Regulation before the Date of Application of the IVDR in May 2022.

The timelines for ensuring your product maintains EU market access under the new, more stringent IVDR, are challenging.

BSI Notified Body would like to share some of our experiences and lessons learnt around the application process. The IVD Team will provide helpful information for updating your Technical Documentation.

Who should attend the webinar?

This webinar will offer notified body insights for all people involved in working towards an IVDR application, whether you are a novice or have significant experience of working with a notified body.  

What will participants gain?

Join this insightful extended webinar to hear from Dr Erica Conway, BSI’s Global Head of IVD Medical Devices, talk about IVDR lessons learnt so far, as well as tips on making applications and the Performance Evaluation requirements under the In Vitro Diagnostic Regulation (IVDR). This is a special extended webinar and Dr Conway will also be joined by subject matter experts, Dr Liz Harrison, Dr Heike Möhlig-Zuttermeister and Judith Prevoo.

The webinar will include:

-          How best to achieve certification with a Notified Body.

-          Lessons learnt around making applications, device schedules/transitions and grouping.

-          QMS audit lessons learnt.

-          General lessons learnt on Technical Documentation reviews.

-          Specifics on Performance Evaluation and technical findings.

-          Questions panel and Q&A session.

Dr Erica Conway, BSI’s Global Head of In Vitro Diagnostic, has over 20 years’ experience in the In Vitro Diagnostic medical device and pharmaceutical industries, within Regulatory Affairs. She took on leadership of the IVD Technical team 5 years ago, to take the UK and NL Notified Bodies through to successful IVDR designations. Erica represents BSI on the IVD NB working group for NB-Med & Team NB.

Judith Prevoo is a Regulatory Lead for BSI The Netherlands Notified Body and she is responsible for the regulatory oversight of medical devices Notified Body strategy, policy, procedures and documentation to meet the various legislative and designation requirements. Before joining BSI in 2018, she gained over 13 years` experience in the In Vitro Diagnostic medical device and pharmaceuticals industries in both scientific and Quality Assurance roles.

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.

Dr Heike Möhlig-Zuttermeister has been with BSI since July 2014, overseeing the conformity assessment work including technical documentation assessments under the IVDD and IVDR conducted by the team as well as qualification, training and mentoring of the technical team and conducting final certification decisions according to the IVDD & IVDR.

Heike holds a PhD in Molecular Immunology and has more than 10 years’ experience in leading R&D departments in the field of life science and IVD industries with focus in Stem Cell Technologies/Cell Therapies/Companion Diagnostics, Genetics, Cancer and infectious diseases.