Episode description
This is the audio from RQM+ Live! #47, recorded 27 January, 2022. The session description below has been abbreviated in order to list the questions.
The equivalence requirements of MDR Article 61 Sections 4 and 5 have been interpreted conservatively thus far by notified bodies and industry. It's simple – for Class III and implantable devices, the manufacturer cannot leverage data from an equivalent device unless the equivalent device either belongs to that manufacturer or that manufacturer has a contract with the equivalent device's manufacturer allowing access to their data. If those requirements cannot be met, the MDR states that the manufacturer must undertake clinical investigations.
Panelists:
- Amie Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
- Jaishankar (Jai) Kutty, Ph.D. – Vice President, Intelligence & Innovation
- Nancy Morrison, RAC – Executive Director, Regulatory & Quality Consulting Services
- Jonathan Gimbel, Ph.D. – Executive Director, Technical Leadership, Clinical & Post-Market Practice
- Andrew Tarnaris, M.D. MD(Res) FRCS(NeuroSurg) – Medical Director
Questions:
2:30 -- Amie, you wrote an opinion paper on the equivalence requirements of MDR Article 61. Can you share why you wrote the paper and summarize your points?
5:30 -- Flowchart shown (video recording only)
9:25 -- Was there a specific device you were working on that spurred you to finally write this down?
12:15 -- Are there any other specific devices you have come across where this would be really helpful?
14:24 -- What devices would this not apply to?
23:13 -- How likely do you think it is that notified bodies would accept this? Have you heard any feedback yet?
27:16 -- If a new device is a further development of a current marketed device, is it possible the clinical data for that marketed device to be still applicable for the next generation device without claiming equivalence provided that there are no expected differences in clinical performance?
28:37 -- If two devices belong to the same generic group, does this mean they need to be equivalent?
29:08 -- For MDR, it shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence. Examples of what conditions would satisfy this requirement?
31:39 -- Is it the case that if the company doesn't have access to the technical file of the equivalent device, that the equivalence argument cannot be substantiated even for Class I-11b devices.
32:16 -- A new WET device as defined by the articles such as a plate or pin which is not CE marked under either MDD or MDR that has no equivalent device, the language in 61-6b would initially lead the reader to believe a clinical investigation is not needed. But the caveat is, without an equivalent device or common spec, you can't support the notion that there is sufficient clinical data, thus a clinical investigation is indeed required. Thoughts?
36:37 -- Is it safe to conclude that Article 61-5 is not applicable to Class IIb or lower, in other words, if Class IIb non-implantable can claim equivalence to another manufacturer's device without access to the tech file, that's OK.
37:58 -- If there any change in the design of a device, does it need to go through the same route - I will use the spinal cage as an example - if there is a new design change in shape in the spinal cage, is it considered a new device category or can it go under the spinal cage category?
40:55 -- What do you recommend companies do right now with this new information?
43:23 -- What else will the naysayers say and why are they wrong?