5 Key Facts You Should Know About SSCP for Your Medical Device

Hello Dear,

It’s been a while since my last newsletter! As you may have seen from my LinkedIn posts, I’ve been busy fulfilling client engagements, and I also had to deal with some unanticipated family emergencies. Luckily, everything went well, and things are back on track.

Life’s ups and downs, right?

We all go through them. If we didn’t experience tough times, we wouldn’t appreciate the good times, nor truly understand the value of family and health.

Well, enough of life lessons—grab your coffee, and let’s dive into the SSCP! 😉

What is the SSCP?

The Summary of Safety and Clinical Performance (SSCP) is a document required by the Medical Device Regulation (MDR) for Class III and implantable devices.

Its purpose is to provide an accessible summary of a medical device's clinical data, safety, and performance.

The SSCP ensures transparency, offering information to both healthcare professionals and, when applicable, patients.

Fact 1: The SSCP Serves Two Audiences

The SSCP may contain two parts:

1. Healthcare Professional Section: This is technical and detailed, providing information to professionals with a medical background.
2. Patient Section (if relevant): This section is written for laypeople and explains the device’s safety and performance in simpler terms.

As a manufacturer, you’ll need to tailor the content for each audience, ensuring clarity and precision.

Fact 2: Readability is Crucial for the Patient Section

One critical aspect of the SSCP is making sure the patient section is easy to understand.

The Notified Body will check its readability to ensure that medical terms are simplified and the information is clear for non-experts.

Tools like the Flesch-Kincaid readability score or tests with actual patients can help ensure that the patient section is easily digestible.

Fact 3: Validation Ensures Compliance and Accuracy

Once the SSCP is drafted, it goes through validation by the Notified Body.

The NB’s role is to make sure that the SSCP aligns with the device’s technical documentation.

Validation also ensures that all required elements, as per Article 32 of the MDR, are included and that the information is accurate.

Once validated, the SSCP is uploaded to EUDAMED (when it becomes available—soon, we hope! 😂), where it’s accessible to the public.

Fact 4: The SSCP Must Be Updated Annually

The SSCP isn’t a one-time submission. It must be updated at least annually, reflecting any new clinical data from Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF).

These updates should coincide with the submission of the Periodic Safety Update Report (PSUR), ensuring the SSCP always reflects the latest data.

Fact 5: The SSCP is Informative—No Promotions Allowed

Remember, the SSCP is strictly informational. The MDR prohibits any promotional content, meaning the SSCP must focus solely on providing transparent and accurate information about the device’s clinical performance and safety.

Final Thoughts

The SSCP is a mandatory document for ensuring transparency between medical device manufacturers, healthcare professionals, and patients. By following these five key facts, you can stay compliant with MDR and streamline the SSCP process for better efficiency.

Ps: On a side note, stay tuned for my next newsletter, where I’ll dive into my August earnings and share some final business lessons from the month. Lots to learn together! 😉

✌️ Peace,

Hatem