While the Summary of Safety and Clinical Performance (SSCP) Article 32 of the European Union (EU) Medical Device Regulation (MDR) is just a half-page regulation, the recently published 24-page guide (see link above) from the Medical Device Coordination Group (MDCG) provides much needed assistance to create these new reports. Manufacturers and Notified Bodies (NB) are pleased with the details and examples that are presented.
However, some are concerned about the increased workload to initially create, update regularly, and then ensure consistencies within the quality management system. These reports must also be delivered in a cost-effective manner to the NB to review, validate and upload into Eudamed. Below are four initial tricks or techniques you may not be aware of to help you develop a SSCP. Please add your favorites too, if you are involved with implantable devices and class III devices that are not custom-made or investigational.
First, readability. For those SSCPs that also are intended for patients, Microsoft Word might help. Go to File, then Options, then Proofing, and check the box to show readability statistics. Now, after spell checking the document, readability statistics will be reported. Flesch Reading Ease is provided. This statistically calculates the readability of your content on a scale that ranges between 0-100. A lower score indicates that the content is more difficult to apprehend. If the score for your content is 100%, then your content is 100% readable, and it can be easily understood by everyone. Your goal here could be ~85%. Next, you will be provided the Flesch–Kincaid Grade Level. This helps you to know how many years of education one needs to understand your SSCP or, in other words, what reading level is needed. Your initial goal here could be grade level 6 or 7. Finally, there is a passive sentence percentage. Your initial goal here could be 20% to 25%.
You will need to strike a balance with these three readability statistics to create the perfect patient section of your SSCP. What about those technical, medical words that patients need to understand? Search for layman language suggestions for medical terminology. Manufactures could also review previous informed consent language, patient guides, or patient training materials to initially find the right words to use.
Second, the right people. Ensure the correct people are involved to get it right the first time. NBs will be looking to confirm consistencies among the submitted draft SSCP (and Instructions for Use) and the specific post-market surveillance (PMS) plan, post-market clinical follow-up (PMCF) plan, clinical evaluation plan, in addition to four reports, e.g., PMCF, clinical evaluation, risk management, and the periodic safety update report. If alignment exists, this could be evidence that the quality system might be functioning as intended. No one has time for re-working the SSCP because of communication challenges among important internal stakeholders.
Third, benefit-to-risk. Manufacturers have historically spent decades fine tuning risk assessments. The EU MDR now brings focus to benefit determinations, which should be based on evidence. Gone are the days of, “We believe.” This represents a huge challenge today. When listing potential benefits and risks, one of the first (of many) things that become evident is units are not the same. Thus, it is not a math problem; it is not possible to use simple math to objectively balance the potential benefits against potential risks. The timing, durations, and combinations of benefits and risks could also be different. Is this a challenge for you? Prior to receiving a guidance from MDCG or other groups, the US Food and Drug Administration recently published tools that I have used to facilitate initial discussions:
(i) Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions (August 2019);
(ii) Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (August 2019). There are two worksheets in this document that are useful to engage discussions about your device.
Fourth, changing regulatory environment. The SSCP is a required element within EU law. Specifically, listing relevant harmonized standards and common specifications. However, manufacturers are also developing global regulatory submission strategies. How are you doing keeping up to date with the changing regulatory environment not only in the EU, but worldwide? There are several ways to implement solutions, but there is one tool that can simplify this for you today. With changes occurring worldwide to medical device laws, standards, guidance documents, white papers, and EU MDR’s common specifications, delegating acts, and implementing acts, BSI’s Compliance Navigator is one tool designed to assist teams to manage regulatory information. This will not only ensure accuracy and provide a single source where information can be found within your organization, but it also provides “heads up” notices on what’s changing or coming up, which should help your planning. I found this tool to help teams work smarter, faster and maximize time to get products approved quicker and remain compliant. A nice additional feature with this tool is the assistance with interpreting standards with expert commentary, which could immediately help newly formed teams involved with creation of MDR-required documents like SSCPs.
Improving SSCP patient readability using Microsoft Word, getting the right people involved initially, understanding how to quantify benefit-to-risk, and keeping up to date with the changing regulatory environment in the EU (and elsewhere) are four solutions that can help both manufacturers and NBs. The results of which will provide health professionals and patients access to important information for device users and health professionals. A win-win-win.
By the way, for this document, Flesch Reading Ease was 37.9%, Flesch–Kincaid Grade Level was 11.9, and passive sentence percentage was 16.6%. I wonder if I should be using this for all those new procedures the MDR is requiring to either be created or updated? It would be a fun exercise knowing who needs to train to these.
Now, it is your turn. Please share your favorite techniques or tricks, if you are involved with SSCPs.
David R Rutledge, Pharm.D, FCCP, FAHA
david.rutledge@globalstrategicsolutions.com
+1 (630) 846-0350
Based in the Silicon Valley area of California, USA