SOLD OUT - IVDR: Practical Implementation of the New Regulation for IVDs

12.0
RAC Credits
Thursday, 11 February 2021 (9:00 AM) - Friday, 12 February 2021 (5:00 PM) Central European Time (CET)

Practical Implementation of the New Regulation for IVDs

This workshop is sold out. If you would like to receive an email notification when this workshop is offered next, please complete the form at https://raps.realmagnet.land/f2f-2021-eu-workshop-ivdr-leadgen-form.

The date of application is drawing closer and there are no indications that there will be a blanket extension to the IVDR. The IVD sector faces significant efforts to plan for and complete before May 2022 to comply with the new IVDR. The transition from complying with the current IVD Directive to meeting the new IVDR requirements involves significant preparation and report/data generation to be ready for additional notified body review and scrutiny. All stakeholders now have some experience reviewing submissions and there are lessons to be learned to improve your submissions and therefore speed to market.

During this two-day workshop, IVD regulatory experts from various stakeholder groups will share some of this practical experience and top tips with delegates. This is an invaluable opportunity to share experience and gain experience from discussions with experts and peers as we all prepare to comply fully with the new regulations. The workshop will be particularly valuable to all regulatory professionals responsible for achieving IVDR compliance for legacy CE IVDD products, but also new IVDs and CDx intended for the European market.

This workshop sold out very quickly in 2020, so early registration advised.

Pricing Amounts & Deadlines

12 December 2020 – 13 January 2021: Early Bird $650 Member | $750 Nonmember
14 January 2021 – 10 February 2021: Regular: $750 Member | $850 Nonmember

Agenda

Day One

The basics of the IVDR, but with case studies and interactive presentations and discussion.

9:00 (CET) — Welcome and introductions

9:15 (1hr) — 1) How to get started with the IVDR; 2) Key definitions, scopes, placing on the market, putting into service timelines, intended purpose; 3) What do you need to consider before you start preparing files?

10:15 (1hr) — Classification and conformity routes

11:15 (15 min)Break

11:30 (1 hr) — Software and IEC 62304

12:30 (1 hr)Lunch

13:30 (1.5 hr) — 1) Technical documentation; 2) The requirements of Annex II

15:00 (15 min)Break

15:15 (1.5 hr) — 1) The Notified Body process; 2) Application process, audits, ISO v IVDR audit, audit subcontractors unannounced audits, sampling, reference labs, companion diagnostic consultation; 3) NB Q&A

16:45Close for the day

Day Two

A deeper dive into the requirements covering the main IVDR pain points.

9:00 (CET) — Recap day one Q& A

9:15 (1hr) — 1) General safety and performance requirements including risk management

10:15 (1hr) — Practical considerations for implementing UDI ready for the IVDR

11:15 (15 min)Break

11:30 (1.5 hr) — 1) Performance evaluation requirements; 2) Key definitions; 3) Scientific validity and literature searches

13:00 (1 hr)Lunch

14:00 (1.5 hr) — 1) Economic operators and the role of the PRRC; 2) Post-market surveillance and postmarket performance follow-up including vigilance

15:30 (15 min)Break

15:45 (1 hr) — 1) Practical considerations for multi-site companies with different technologies; 2) How to project manage the IVDR implementation; 3) Breaking the elephant into bite-size pieces; 4) Communication; 5) Stakeholders; 6) Lessons learned

16:45 (1.5 hr) — 1) Final wrap-up; 2) Discussion Q&A

16:45Close for the day

Speaker

Sue Spencer

Sue Spencer, BSc (Hons)
IVD Lead and Principal Consultant

Sue leads Qserve’s IVD service, she has over 30 years’ experience in the Medical Device and IVD industries including extensive notified body experience.

Key areas of expertise include:

  • IVDD and IVDR regulations
  • QMS implementation
  • Internal, supplier, and compliance audits
  • Risk Management
  • Training
  • Working with small start-up and multinationals

Sue has worked for several IVD companies ranging from start-up to large multinationals, where she has held positions in R&D, manufacturing, and quality assurance. Sue worked for three notified bodies, establishing two from scratch. Sue chaired the European IVD Notified Body Working Group coordinating the notified body responses to the regulations. Sue also participated in the Commission IVD Technical Work Group for many years.

Sue is an experienced trainer on a variety of IVD topics and particularly enjoys creating workshops to improve hands-on experience with the requirements.

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 the event title. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance upon request.

Questions

Call RAPS Solutions Center at +1 301.770.2920, Ext 200