Summary of Safety and Clinical Performance MDR Services
Elexes helps medical device manufacturers prepare clear, defensible SSCP documentation under EU MDR, aligning clinical evidence, risk management, PMCF, and technical files to support Notified Body expectations and smoother market access. From strategy through authoring and remediation, our team brings structured regulatory support that reduces review friction and strengthens compliance confidence.
Our Summary of Safety and Clinical Performance Services
Focused EU MDR support for SSCP preparation, evidence alignment, remediation, and submission readiness.
SSCP Strategy
Develop a structured SSCP approach by aligning device classification, intended purpose, clinical evidence, and post-market obligations with EU MDR expectations for applicable devices.
Clinical Evidence Support
Strengthen the evidence base behind your SSCP through CER support, literature review, PMCF alignment, and defensible benefit-risk justification for higher-risk devices.
Technical File Alignment
Connect SSCP content with Annex II and III documentation, GSPR evidence, risk management outputs, labeling, and post-market records for a coherent review package.
Gap Assessment
Identify weaknesses in SSCP-related documentation, traceability, and clinical rationale with a targeted assessment mapped to EU MDR requirements and remediation priorities.
Remediation Support
Close documentation and evidence gaps with hands-on support across SSCP drafting, clinical evaluation updates, PMCF outputs, and cross-referenced technical documentation.
Submission Readiness
Evaluate whether your SSCP and supporting records are ready for Notified Body scrutiny, reducing avoidable questions, delays, and rework before submission.
Clinical Clarity
Defensible SSCP Support Under EU MDR
For Class III and implantable devices, the SSCP is more than a summary document—it must accurately reflect your clinical evidence, residual risks, intended purpose, and post-market conclusions. Elexes helps manufacturers build SSCP content that is clear, traceable, and aligned with CERs, PMCF outputs, risk files, and Annex II/III documentation, so your submission tells a consistent compliance story.
Trusted By Manufacturers
Success Stories
Supporting medical device teams with structured regulatory documentation and submission-focused MDR consulting.
“Kudos to the Elexes team! They’re always proactive and have provided invaluable support to us with import, labels, and registrations.”
Philip McFerran
“Having Elexes as our import-export expert was a great choice. Elexes’ team answered all our questions and guided us through every step.”
Linda Pan
“Highly recommend Elexes! They always meet commitments and follow through on action items.”
Joshua Mink
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
“Kudos to the Elexes team! They’re always proactive and have provided invaluable support to us with import, labels, and registrations.”
Philip McFerran
“Having Elexes as our import-export expert was a great choice. Elexes’ team answered all our questions and guided us through every step.”
Linda Pan
“Highly recommend Elexes! They always meet commitments and follow through on action items.”
Joshua Mink
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
“Kudos to the Elexes team! They’re always proactive and have provided invaluable support to us with import, labels, and registrations.”
Philip McFerran
“Having Elexes as our import-export expert was a great choice. Elexes’ team answered all our questions and guided us through every step.”
Linda Pan
“Highly recommend Elexes! They always meet commitments and follow through on action items.”
Joshua Mink
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product’s nuances quickly.”
Michal Depa
The Elexes Difference
Why Choose Elexes?
Manufacturers rely on Elexes for rigorous, submission-focused regulatory support.
Experience
50+ years of collective regulatory experience across medical device compliance and submissions.
End-to-End
Support spans strategy, documentation, remediation, approvals, and post-market regulatory obligations.
Global Reach
Expertise across EU MDR, FDA, Health Canada, TGA, and other major frameworks.
Proven Results
250+ successful projects and a 90% audit clearance rate demonstrate disciplined execution.
Meet The Elexes Team
Experienced specialists in medical device regulatory compliance.
Elexes Medical Consulting Pvt. Ltd. supports medical device manufacturers with practical, high-accountability regulatory and quality consulting across global markets. Over the years, the company has become a trusted partner for regulatory approvals, due diligence, clinical documentation, QMS support, and post-market compliance. With 50+ years of collective experience, the Elexes team works across EU MDR, FDA, TGA, Health Canada, and other frameworks to help clients move from uncertainty to defensible submissions. Their approach combines regulatory depth, clinical understanding, and structured project execution, giving manufacturers a reliable external partner for both targeted engagements and end-to-end compliance programs.
250+ ProjectsSuccessful regulatory and compliance engagements completed.200+ Product TypesExperience across diverse medical device categories.90% Audit ClearanceStrong track record in inspection and audit readiness.
Frequently Asked Questions
What are Class IIa IIb and III medical devices?
Under EU MDR, Class IIa, IIb, and III devices are medium- to high-risk medical devices classified by intended purpose and risk profile. Class IIa generally covers lower-medium risk devices, Class IIb includes higher-risk active or long-term use devices, and Class III covers the highest-risk products such as many implantables. Classification affects conformity assessment, clinical evidence depth, and whether an SSCP is required.
What is the difference between EU MDR and IVDR?
EU MDR applies to general medical devices, while IVDR applies specifically to in vitro diagnostic devices such as assays, reagents, and diagnostic instruments. Although both regulations increase scrutiny around evidence, documentation, and post-market obligations, IVDR uses performance evaluation concepts tailored to diagnostics, whereas MDR focuses on clinical evaluation and device safety and performance in patient use.
What is sscp in medical devices?
SSCP stands for Summary of Safety and Clinical Performance. Under EU MDR, it is required for Class III devices and implantable devices, with limited exceptions. The document is intended to present key information about the device’s safety, clinical performance, intended purpose, residual risks, and clinical evidence in a clear format for users and patients, while remaining consistent with the technical documentation.
Which devices require an SSCP under EU MDR?
An SSCP is generally required for Class III devices and implantable devices under EU MDR, except for certain well-defined exemptions. Whether your device qualifies depends on its classification, intended purpose, and regulatory status. The SSCP must be validated through the conformity assessment process and kept aligned with the current clinical evaluation, risk management, and post-market surveillance documentation throughout the device lifecycle.
What information should be included in an SSCP?
An SSCP typically includes device identification details, intended purpose, indications, target populations, contraindications, residual risks, undesirable effects, summary of clinical evaluation, and relevant post-market follow-up information. It should also reflect benefit-risk conclusions and be consistent with labeling, CER content, PMCF outputs, and technical documentation. Accuracy, traceability, and readability are all essential for a defensible SSCP.
How does the SSCP relate to the Clinical Evaluation Report?
The SSCP is not a replacement for the Clinical Evaluation Report; it is a public-facing summary derived from the broader clinical and regulatory evidence base. The CER contains the detailed methodology, literature appraisal, data analysis, and clinical conclusions, while the SSCP presents key safety and performance information in a concise format. Any inconsistency between the two can create review issues during conformity assessment.
Can an SSCP be prepared before the technical documentation is complete?
A draft SSCP can be started early, but it should not be finalized in isolation from the technical documentation. Because the SSCP depends on stable inputs from the CER, risk management file, PMCF documentation, labeling, and device description, preparing it too early often leads to inconsistencies and rework. The strongest approach is to develop it alongside the final stages of evidence and documentation alignment.
How often should an SSCP be updated?
The SSCP should be reviewed and updated whenever relevant information changes, especially after updates to clinical evaluation, PMCF findings, risk management conclusions, labeling, or post-market surveillance outputs. It is not a one-time deliverable. Manufacturers should treat it as a controlled regulatory document that evolves with the device’s evidence base and remains consistent with the current approved technical documentation.
Still Have SSCP Questions?
Speak with regulatory experts about your MDR documentation strategy.
Certified & Trusted
Awards and Recognition
ISO 13485
Medical device quality system expertise.
MDSAP
Multi-market audit readiness support.
IEC 62304
Software lifecycle compliance knowledge.
