Episode description
This is the audio from RQM+ Live! #48, recorded 10 February, 2022. The session description below has been abbreviated in order to list the questions.
On 26 August, 2021, we conducted a Live! show on the topic of sustaining EU MDR and IVDR, and we were flooded with audience questions... which we loved! We ran out of time and promised a round two to give everyone a chance to pose their questions to our panel of former notified body leaders and industry experts. Five months have passed and our educated guess is you have even more challenges and questions to bring to the table. If you do, our team is ready for them.
While many of you in the device industry have achieved certification for some or all of your products, we know it can be just as big of a challenge to keep up with all the new requirements for post-market reporting and documentation updates. For IVD manufactures, hang on to your hats because as your device colleagues can attest, you have a difficult road ahead and the post-certification phase will not provide much relief.
As always, our RQM+ experts are thrilled to utilize our Live! show platform as a way to knowledge-share across the industry. Please bring your toughest questions and join the discussion because we're here to help!
Panelists:
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
- Carlos Galamba, MSc - Vice President of IVD Intelligence & Innovation
- Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services
- Jonathan Gimbel, Ph.D. – Executive Director, Technical Leadership, Clinical & Post-Market Practice
Questions:
3:29 -- Summarization of new requirements of the post-market phase (if watching video, includes with graphic)
5:40 -- In preparation for MDR, how long should updating everything actually take and how long is too long?
8:04 -- In preparation for IVDR, how long should updating everything actually take and how long is too long?
8:59 -- Is there an ETA for the MDCG guidance template for PSURs?
10:04 -- Do you believe that EUDAMED when it actually goes live will be a good resource for post-market data in the same vein as MOD when doing updates for the CER and PMCF?
13:44 -- What experience have you seen from the notified bodies for accessing the readability of the SSCPs?
19:09 -- If three months is the suggested timeframe for having most recent data, then how is the RQM+ PMCF completion of 29-32 weeks falling in this schedule? What are the chances the notified body would comment that the data doesn't have value?
21:05 -- What kind of data specifically has to be less than six months old?
24:03 -- Have you had feedback on if deviating from IFU language is acceptable for the SSCP to improve readability to that 14-year-old level?
27:14 -- Our regular moderator Lisa forgets to unmute herself for the first time in the history of RQM+ Live! She had a good run. ;-)
27:24 -- Should MDCG be referenced in the GSPR checklist or rather in the body of the Annex II technical documentation?
29:18 -- Our company believes that resource levels should go down after certification. How do I convey that maintenance in PMS will be intensive? (answered by function)
37:18 -- In September of 2021, BSI did a webinar about PSURs and PMS reporting and stated that data outside the 90-day window was not acceptable. Has that changed?
38:22 -- What is an acceptable frequency for the PMCF literature search activity for different classes of devices?
39:29 -- How much harder is a design change MDR than it was under MDD?
41:17 -- Is a PMCF plan required for Class Is devices?
42:36 -- What do you recommend IVD manufacturers be thinking about or implementing now to be ready for the sustaining phase?