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Sue Spencer & Lorry Weaver Re-Cap the Sold Out RAPS IVDR Workshop | Read More for the Full Review from Last Week!

Speaking to a sold-out workshop on EU IVDR, a well-rounded panel of presenters offered insights from various sides of the IVDR table.  Including Qserve consultants who have extensive experience interpreting the IVDR and helping companies implement processes, procedures—to industry experts from Hologic who have embarked on an IVDR implementation program since 2017—and then to the Notified Body (TÜV SÜD) who are responsible for carrying out the regulation and ultimately issuing CE Mark and Quality certificates.

Attendee Testimonials

"You are all doing a great job! The presentations are great! One of the best webinars I've attended!"

"This workshop is very valuable!"

"Presentations and presenters have been excellent. Thank you everyone!"

Recurring themes from all speakers were 1) intended purpose and 2) read, re-read, and read again the regulation text.  All processes start with a sound and clear intended purpose. The content requirements are stated in Article 2, Annex I, Annex II.  Most companies have to revise their devices intended purpose since the existing ones do not cover the detail expectations of the IVDR.  Performance, risk, PMS all have to be executed with the intended purpose as the cornerstone. 

Click here for an extensive discussion on intended purpose.

If you haven’t read the ENTIRE IVDR, it’s a must!  Don’t miss the recitals at the beginning as they provide insight into the thinking of the Commission in setting forth the structure and multitude of requirements.  It tells you what problems they wanted to solve and therefore where they will place their regulatory focus.  Next are the Articles that state what is required followed by the Annexes that describe how to meet the requirements.  “The devil is in the details” phrase was used to encourage delegates to read, read, and read again.  Every time through, new insights are gained as well as ‘ah ha’ moments once particular elements and execution are attempted.Julien Senac, Director, IVD Global Focus Team, TÜV SÜD, provided a nice overview of the process the NB will go through with manufacturers, expert panels, and competent authorities as needed to result in issuance of certificates.  A key take-away by attendees is to read and study Annex VII, Requirements to Be Met By Notified Bodies!  Understanding what the NB will be held accountable, take a look through their eyes, it will really bring clarity and importance to various requirements.

Take time to understand the terminology used in the IVDR– almost none of the language in the IVDR is used in existing procedures and data reports. It’s like learning a new language!  Gail Gasior, Director, Clinical Compliance and Clinical Operations, Hologic Diagnostic Solutions, as she explained the challenge with the new terms and report requirements.  One of the first challenges during the data gap assessments was figuring out what existing information constitutes clinical evidence and what can be slotted into scientific validity, analytical or clinical performance and how these relate to performance evaluation.  All existing procedures have to be revised to realign and incorporate the new terminology and requirements.  Do not under-estimate the challenge learning and this new language and then disseminating this and making it part of your company regulatory vocabulary.

Hearing from Terrie Dosenberry, PMP Director, Program Management RA/QA, Hologic Diagnostic Solutions, we learned about the real struggles and actions taken to understand Economic Operator (EO) who are the EO and their roles and responsibilities.  The acronym MAID is helpful to remember who the EO are; Manufacturer, Authorized Rep, Importer, Distributor.  We learned that the first step taken by Hologic was to identify who all the EOs are within the company.  This can sometimes look like a plate of spaghetti but it is important to understand it.  Reshuffling of importers and distributors might want to be made to best accommodate the business needs and to address the willingness of particular Economic Operator's to fulfill their roles (refer to Articles 10-14).  A key-takeaway from the presentation is that YOU (the manufacturer) are the common denominator with all the EO.  Every EO has skin in the game so they should all be happy to be involved in creating and fostering the relationship.

From EO, the workshop moved to the Person Responsible for Regulatory Compliance (PRRC).  Qserve has developed a 2-day PRRC course on this subject. 

The final session was on the Project Management of the IVDR implementation program.  Although Terrie’s intent was to inform and describe her journey and experience at Hologic Diagnostic Solutions, there was a sense of urgency and enormity conveyed that was palpable among attendees.  A very daunting task; proverbial “Elephant in the Room”-- but can be tackled piece by piece with careful planning, training, partnering with internal stakeholders, and external experts!

Some tools and key points shared included: 

  • Envision the end—how you want to end and then bring it back to how you need to start
  • Before you can communicate, you need to educate---have to share with the organization. 
  • Map your current organization into the activity flows of the regulation.
  • Identify and engage stakeholders – anyone who has an impact or can impact your project’s success.
  • Communication---how people hear things is different. Keep message coming and keep it consistent.  Adapt mechanisms to meet hearing styles and needs. 
  • IVDR implementation and on-going compliance is not only Regulatory and Quality functions responsibility, it’s the entire organization—get everyone involved.
  • Remediation is not only effort (existing products re-tool to keep on market)
  • Sustaining is SIGNIFICANT---PMS and PMPF plans
  • Create timelines—shocking how much there is to do and so little time to do. Have to include NB cycle times –can be 12 months or 6 months.
  • Need someone (Project Manager) to bring it all together—everything works in concert and if everyone is off doing their piece, you don’t know how it’s all going together.
  • A key to success conveyed by Gail in closing her session on Practically Implementing the IVDR Performance Evaluation was love  My IVDR Program Director

Thanks to RAPS and all the participants and attendees for making this such a great event!

 

Join us July 9th for an IVDR Webinar hosted by RAPS Salt Lake City Chapter, MasterControl & Qserve. 

Sue Spencer
Lorry Weaver, MT(ASCP), CLS(NCA)
Post date: June 17, 2020
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