In case you missed it, the latest presentation in our webinar series covers the new requirements under EU MDR and IVDR: the Summary of Safety and Clinical Performance (SSCP) and Summary of Safety and Performance (SSP), respectively. It’s no surprise that manufacturers are finding it challenging to produce these reports because they are completely new to everybody.
Fortunately, with former notified body leadership on our team, we have some unique insights that will help you overcome the most common challenges and streamline the writing process. This webinar is presented by four RQM+ team members with extensive expertise in MDR and IVDR compliance:
- Jon Gimbel, Ph.D., Executive Director, Technical Leadership, Clinical & Post-Market Practice
- Jaishankar “Jai” Kutty, Ph.D., VP, Clinical and Post-Market Practice
- Amie Smirthwaite, Ph.D., Senior VP, Intelligence & Innovation
You will learn from these industry and notified body experts with intimate knowledge of the intentions behind the regulations and MDCG guidance and expectations of the notified body reviewers. This webinar covers far more than just how to write SSCPs and SSPs. You'll leave with actionable tips on overcoming common challenges, aligning with CERs and PERs, meeting the timelines for delivering and updating these documents, and much more.
How to Interpret SSCP and SSP Requirements
It can be challenging for manufacturers to know how to interpret SSCP and SSP requirements according to notified body expectations. Read on to explore the guidance and regulation in-depth.
What is the regulation?
EU MDR requires an SSCP for Class III and implantable medical devices. Similarly, under IVDR, an SSP is required for Class C and D IVDs.
Why are SSCPs and SSPs required?
The intent behind the regulations is to provide transparency about the extent of data toward regulatory approvals to end users and patients, and manufacturers should use this lens for writing these documents and deciding when to update them.
When must SSCPs and SSPs be updated?
While PERs and CERs need to be updated annually, SSCPs and SSPs must be updated regularly as needed—most often in cases where the information obtained in the PSUR renders the SSCP or SSP information incomplete or incorrect. However, the guidance doesn’t spell out all of the triggers that might cause an update, so it is up to manufacturers to evaluate whether any changes have caused a significant impact on the conclusions and benefit-risk analyses in the SSCP or SSP. In this webinar, we cover some examples of triggers to be aware of as you start updating these documents.
What insights do former notified body leaders provide?
Presenters with recent experience at notified bodies share what they have seen both as reviewers and as industry consultants. Spoiler alert: The guidance is not being followed in the way it should be, which is leading to documents getting rejected, thus increasing the lead time for what is already a lengthy review process.
One of the biggest gaps we have seen for SSCPs specifically is that manufacturers are technically complying with the MDR but aren’t following the guidance. This is most likely because systems got updated with the rollout of MDR but aren’t subsequently updated after the guidance was released.
The webinar also covers a long list of other gaps we have seen with SSCPs and SSP, including:
- Risk quantification and relation to time
- Survival rates for medical devices and false positives or negatives for IVDs
- Expected lifetime discussion for implants
- Readability of the patient portion
- Justification for the omission of the patient portion
- Safety and performance objectives
- Patient-specific clinical benefits
- Residual risks and undesirable side effects
- Inaccurate device or accessory description, model variants, or material information
- Listing of all relevant clinical investigations
- Incorrect device nomenclature code (GMDN code used, not EMDN)
- SSCP/SSP that covers multiple products
- Detailed description of training requirements for end users
How do you apply this guidance to SSPs?
IVD manufacturers are faced with an extra challenge because no SSP guidance has been released yet, and we’re not likely to see it any time soon. The solution is to interpret the SSCP guidance and apply the same concepts to SSPs, such as:
- Considering readability for lay users
- Implementing stylistic requirements
- Sourcing all information from the technical documentation
- Including favorable and unfavorable data
- Providing a comprehensive and traceable summary of clinical evidence
How to Write SSCPs and SSPs
Although they are new requirements under MDR and IVDR, the RQM+ team has unique insights into the best practices for generating SSCPs and SSPs. In addition to participating in the development of the guidance, we have also seen responses from notified bodies and, therefore, have a keen sense of how to overcome the most common challenges manufacturers face.
Common questions manufacturers ask include:
What content should be included?
Notified bodies are closely following the guidance and expect manufacturers to include every item in the table of contents from the guidance document. However, we have also seen that notified bodies are using this as a starting point, and it represents the bare minimum that should be included. For IVDs, there is no equivalent SSP guidance, and notified bodies are accepting the requirements in article 29 of the IVDR as the bare minimum, but they also expect manufacturers to go one step further and adapt equivalent SSCP guidance when it comes to stylistic requirements, administrative details, and translation requirements, for example.
How much clinical data detail should be included?
Manufacturers are naturally concerned about divulging confidential information or providing details they don’t want competitors to see. When it comes to medical devices, all of the information included in the SSCP is already publicly available, so this concern is easy to allay. For IVDs that have proprietary formulations, there are ways to provide enough detail to meet the requirements without compromising confidentiality.
How do I write the patient portion?
One area where manufacturers tend to struggle is with respect to the reading level of the patient portion of SSCPs and SSPs. Firstly, the guidance is vague, so it’s not surprising that this is a common challenge. The intent for the patient portion of the document is that it can be understood by a layperson who has no medical education, so use this lens for evaluation. You can also validate readability in multiple ways, including user surveys, labeling comprehension studies, and other methods.
How do I present the residual risk table?
For medical devices, residual risks must be quantified over a defined time period to help clinicians and end users better understand the associated risks. The data presented should include:
- Potential undesirable effects
- The probability of the effects happening
- When the effects were reported
- The source of the data
- Any considerations for underreporting
In the absence of specific IVDR guidance, the SSP requirements are less prescriptive when it comes to the residual risk table, but it is still important to present any relevant data cohesively.
How do I address patient benefits?
The summary of results should explicitly state any patient benefits, but this is often overlooked when writing SSCPs. It’s also not uncommon for patient benefits to get rolled into the device performance section. According to the guidance in MDCG 2019-9 section 5.4:
“Give a description of the documented clinical benefits for patients with relevant and specified clinical outcome measures, and the success rate for achieving the outcome measures. This should be described for all clinical claims the manufacturer presents in the IFU, and in any information, marketing, or promotional material that it distributes.”
If patient benefits are not clearly defined and quantified in your documentation, you can expect questions from your notified body. For most IVDs, the concept of clinical benefits is limited to the provision of accurate medical information that is used to diagnose, guide medical interventions, or select further testing, for example. The IVDR requires patient benefits to be addressed in this context rather than measuring final clinical outcomes because they largely depend on available therapeutic options and/or further diagnostic testing.
How do I appropriately quantify data?
We have seen that notified bodies are asking for a more quantified benefit-risk analysis across all technical documentation. Start by making sure that your SSCP aligns well with your CER or PER and list all clinical benefits. You may need to work with a statistician to analyze your data if your notified body comes back with findings.
How do I align SSCPs and SSPs with other documentation?
The content in an SSCP or SSP must come from the CER or PER, so it’s critical that these documents are consistent. Update any templates you use to ensure that they align with each other. Keep the big picture in mind as you update PMCF/PMPF reports, PSURs, and CERs/PERs, and create systems for a continuous feedback loop.
How do I know what triggers an update?
Because SSCPs and SSPs must be updated when certain information comes to light, it can be challenging for manufacturers to know when action is required. Any time an update is considered, document these considerations so you have justification available if it is needed in the future. Create a process that triggers consideration with certain events, documents the decision, and implements updates as needed.
For more details on how to interpret the regulations and write SSCPs or SSPs that meet notified body expectations, watch the on-demand webinar and hear it directly from the RQM+ team.