RAPS Convergence Wrap Up | How to Tackle the Biggest Challenges of SSCP’s

It was a pleasure to speak at RAPS Convergence this week. We had a great session during which we learned:

1. Different stakeholders are likely interested information within (i.e. different parts of) the SSCP

            e.g. Health Care Providers (HCP)

Section 4 - information on any residual risks and any undesirable effects, warnings and precautions.

                        Section 5 - summary of clinical evaluation and relevant information on PMCF

                        Section 6 - possible diagnostic or therapeutic alternatives

e.g. Patients

            Section 1 – identification of the device and the manufacturer

Section 2 – intended purpose, indications, contraindications and target patient populations;

Section 4 - information on any residual risks and any undesirable effects, warnings and precautions.

2. There are many different readability metrics (such as Flesch-Kincaid Grade Level and Dale-Chall readability formula) one can use to assess the readability of part B of the SSCP, and Diana Nogueira recommended some with a detailed explanation; but that these indices alone are not enough! One can "game" the indices to improve their scores but that may not actually improve the readability. Using expert medical writers, and perhaps readability assessments (as recommended by MDCG 2019-9), to assess how well lay-users understand the content will also be necessary.

3. How to provide the quantitative data required by MDCG 2019-9 and linking it to our risk-acceptability criteria - I examined several approaches and recommended the one that seems most justifiable to me - i.e. basing quantitative rates for harms/side-effects on data from clinical investigations where you have them, or meta-analyses of relevant literature, with data from complaints and vigilance serving as a good signal detection method for telling us when things are getting better or worse, but not for quantitative rate estimation due to under-reporting and many other problems (that we covered in the session) with the detail contained (or rather not contained) within these data. This may lead to a "re-calibration" of the typical Occurrence of Harm scores with see used in risk management once these are based on clinical investigation data (and devices USED) rather than just complaint data (and devices SOLD) – e.g. the “Unlikely” category may change from ≥0.001% and <0.01% of devices sold to ≥0.5% and <3.0% of devices used, or some such adjustment.

4. This will mean we need the services of statisticians more often as we create an maintain many of the documents required under MDR, such as SSCPs, CEPs, CERs, RMPs, RMRs, PMS plans, PMS reports/PSURs, PMCF plans, PMCF reports and the like.

5. What the NBs will be looking for and how the validation process of SSCPs will work, including things that they will typically look for in the TD review (such as quantitative data in SSCPs and consistency with risk management) and those that may be audit topics (such as the process for translation of the SSCP).

Thanks to my fellow presenters Diana Nogueira and YVONNE NDEFO for their excellent presentations and to Regulatory Affairs Professionals Society (RAPS) for putting on such a great event and the opportunity!

Thanks too to all who attended and engaged with questions. Any follow-ups, please reach out!
Keith Morel, PHD
Datum der Veröffentlichung: September 30, 2021
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