Episode description
This is the audio from RQM+ Live! #49, recorded 24 February, 2022. The session description below has been abbreviated significantly in order to list the questions covered. You can read the full description here.
Whether you've already created PSURs and are looking for ways to optimize and improve, or haven't started yet, you'll want to hear our panel of experts discuss best practices and lessons learned based upon case studies of successes, failures, and notified body feedback so far.
Questions:
2:24 -- What is your experience so far with supporting the industry with PSURs?
3:35 -- Have you had any notified body feedback yet on PSURs?
10:54 -- Is there any news on when the guidance is coming?
12:20 -- What needs to be covered in respect to same/similar to medical devices in PSURs?
14:47 -- Any best practice for implementing expected undesirable side effects to our end process?
16:12 -- What is the team's view on whether a CER should always be updated following an update of the PSUR and what are the different purposes of the PSURs vs. the CER? [link to RQM+ webinar referenced]
18:25 -- When does the first PSUR for medical devices need to be prepared according to EU MDR?
20:35 -- Where are you really seeing manufacturers first struggle? Where's that first hurdle?
22:47 -- From a notified body perspective, what are people missing in their PSUR programs?
29:14 -- Could you please discuss how the PSUR is related to the PMS Report and PMCF Report? Or all three documents required or can we only provide a PSUR?
30:49 -- What time period should be considered in a PSUR?
31:42 -- The draft PSUR guidance we've seen from MDCG notes the first PSUR being due December 2022 for Class III and IIb. Should this be taken with a grain of salt until guidance is finalized?
33:49 - How should we handle adverse events if our device is very new?
34:28 -- Interesting comment from the audience: their PSUR was inspected onsite in an annual QMS audit in August of 2021 by BSI.
34:48 -- Back to same/similar, when the company itself has same/similar products which are not medical devices, where you would have a lot of information like sales volume complaints as well, should that also be included in the PSUR or is that overload? (reference to mouthwash)
37:14 -- A lot of the information required by PSURs seems redundant to the information contained in the CER for the medical devices. How does this info need to be reported and analyzed differently in the PSUR, if at all.
38:05 -- What happens if there is a lot of clinical data on a similar device that is not marketed anymore in Europe, but it was marketed before? Can we use that data for comparison with our device under evaluation?
39:37 -- How would a manufacturer of a reusable surgical instrument that is categorized as Class IIa calculate a complaint rate for a five-year period when the devices cannot be used beyond the five-year PSUR review period?
40:41 -- In the absence of IMDRF codes for summarizing non-serious incidents, is it acceptable to use internal coding or should internal coding be translated to the applicable IMDRF code?
41:23 -- How soon do you expect notified bodies to require IMDRF coding only for PMS data presentation in PSURs?
41:55 -- How do we select similar devices - can we select a few or should we include all in the PSUR?
42:31 -- Is there any requirement to conduct a technical literature review in the context of the PSUR?
43:06 -- Should benefit-risk analysis be part of the PSUR or CER?
45:55 -- Population using the device - should it be understood as a patient