RQM+ Live! #48 —Part 2: Sustaining EU MDR and IVDR certification in the post-market phase - What will it take?

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! 

We'll kick off the discussion with the questions we didn't get to last time, including: 

• "How long should "update everything" take? How long is too long?"
• "Do you believe that EUDAMED (when it eventually goes live and is fully functional) will be a good resource for post-market data in the same vein as MAUDE when doing updates for the CER and PMCFs?"
• ​"What experience have you seen from the notified bodies for the readability of SSCPs?"
• "Should MDCG be referenced in the GSPR checklist or rather in the body of the Annex II Td?"
• "My company believes that resource levels should go down after certification. How do I convey that maintenance and PMS will be intensive?"

Here's our panel:

• 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