GSPR Checklist & General Safety Performance Requirements Support
Build a device-specific GSPR checklist that clearly maps each applicable Annex I requirement to standards, test reports, clinical evidence, and risk files. Elexes helps medical device manufacturers create traceable, review-ready documentation that supports EU MDR technical files, reduces Notified Body questions, and strengthens CE marking submissions.
Our GSPR Checklist Services
Targeted support for building, reviewing, and defending GSPR compliance documentation under EU MDR.
GSPR Checklist
Develop a device-specific GSPR matrix that maps each applicable Annex I requirement to objective evidence, including standards, test reports, clinical data, and risk management outputs.
EU MDR Gap Assessment
Identify missing evidence, weak justifications, and documentation gaps across your technical file so your team can prioritize remediation before Notified Body review.
Technical Documentation
Structure and strengthen Annex II and III documentation so GSPR conformity links clearly with device description, verification data, PMS records, and clinical evaluation.
Risk Management
Align ISO 14971 risk files with Annex I requirements to ensure hazards, controls, residual risks, and benefit-risk conclusions support your GSPR claims.
Submission Readiness
Assess whether your GSPR checklist and supporting evidence are complete, traceable, and defensible before engaging a Notified Body or finalizing CE marking timelines.
Remediation Support
Close identified compliance gaps with hands-on support for updating justifications, cross-references, evidence tables, and technical documentation sections tied to GSPR requirements.
Annex I Support
Turn GSPR Requirements Into Clear Evidence
A strong GSPR checklist does more than list requirements. It shows exactly how your device meets each applicable Annex I obligation and where the supporting evidence lives. Elexes helps manufacturers build complete, traceable, and defensible GSPR documentation that aligns with EU MDR technical files, risk management records, clinical evidence, and labeling so reviewers can follow the compliance story without ambiguity.
Trusted By Manufacturers
Client Outcomes
Regulatory support that helps manufacturers strengthen submissions and reduce avoidable review delays.
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.”
Samip Shah
“Professional and easy to work with! They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports and provided advice on testing and manufacturing.”
Daniel Kinsey
“Highly recommend Elexes! They always meet commitments and follow through on action items.”
Joshua Mink
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.”
Diane Bryant
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.”
Samip Shah
“Professional and easy to work with! They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports and provided advice on testing and manufacturing.”
Daniel Kinsey
“Highly recommend Elexes! They always meet commitments and follow through on action items.”
Joshua Mink
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.”
Diane Bryant
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.”
Samip Shah
“Professional and easy to work with! They have been instrumental in getting CE Marking for our products in the quickest way. They created clinical evaluations and risk assessment reports and provided advice on testing and manufacturing.”
Daniel Kinsey
“Highly recommend Elexes! They always meet commitments and follow through on action items.”
Joshua Mink
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.”
Diane Bryant
The Elexes Difference
Why Choose Elexes?
Manufacturers rely on Elexes for structured, evidence-driven regulatory support.
Deep Expertise
50+ years of collective experience across EU MDR, FDA, ISO 13485, and global device regulations.
Traceable Documentation
We connect GSPR requirements to standards, testing, clinical evidence, and risk files with clear traceability.
End-to-End Support
From gap assessment through remediation and submission readiness, we support the full compliance lifecycle.
Proven Results
250+ successful projects and a 90% audit clearance rate reflect disciplined regulatory execution.
Meet The Elexes Team
Experienced regulatory specialists supporting complex device submissions.
Elexes is a trusted medical device regulatory consulting partner supporting manufacturers across the full compliance lifecycle. The team brings 50+ years of collective experience across EU MDR, FDA, ISO standards, and global market access pathways. Elexes has supported more than 200 clients worldwide with regulatory approvals, technical documentation, quality system support, and post-market compliance activities. With experience spanning 200+ product types and 250+ successful projects, the company is known for structured execution, practical remediation, and documentation that stands up to regulatory scrutiny. For manufacturers preparing GSPR checklists and broader EU MDR technical files, Elexes focuses on building clear evidence trails, reducing avoidable deficiencies, and helping teams move toward submission with greater confidence.
200+ Product TypesExperience spanning broad technologies and risk classes.90% Audits ClearedStrong record of audit and inspection readiness.250+ Successful ProjectsDelivered across diverse medical device categories.
Frequently Asked Questions
What is the GSPR checklist?
A GSPR checklist is a structured matrix used under EU MDR Annex I to show how a medical device meets each applicable General Safety and Performance Requirement. It identifies whether a requirement applies, explains the method of conformity, and links to supporting evidence such as harmonized standards, test reports, risk management documents, labeling, clinical evaluation, and post-market records.
What is GSPR in EU MDR?
GSPR stands for General Safety and Performance Requirements. These are the core safety, design, manufacturing, labeling, usability, and performance obligations set out in Annex I of EU MDR 2017/745. Manufacturers must assess each requirement for applicability and demonstrate conformity with objective evidence in their technical documentation to support CE marking and Notified Body review.
Who needs a GSPR checklist under EU MDR?
Any manufacturer preparing technical documentation for a medical device under EU MDR needs a GSPR checklist. It is especially important for CE marking submissions, legacy device transitions, significant changes, and Notified Body reviews. The checklist helps demonstrate that Annex I requirements have been systematically assessed and supported with traceable evidence across the technical file.
What documents are typically referenced in a GSPR checklist?
A well-built GSPR checklist usually references harmonized standards, common specifications, verification and validation reports, biocompatibility data, software documentation, clinical evaluation reports, risk management files, PMS or PMCF records, labeling, and IFUs. The goal is to show exactly where conformity evidence exists and ensure each reference is current, relevant, and consistent with the device’s intended use.
How is a GSPR checklist different from a simple compliance checklist?
A simple compliance checklist often lists requirements without proving conformity. A proper GSPR checklist is evidence-based and device-specific. It evaluates applicability, explains the rationale for conformity, and links each requirement to supporting documentation. That level of traceability is what Notified Bodies expect when reviewing EU MDR technical files, especially for higher-risk or more complex devices.
Can harmonized standards alone prove GSPR compliance?
Not always. Harmonized standards are important because they provide a recognized route to demonstrating conformity, but they do not replace the need for device-specific evidence. Manufacturers still need to show how standards were applied, where test results support compliance, and how risk management, labeling, clinical evidence, and post-market data collectively address the applicable GSPR requirements.
What are the most common problems found in GSPR checklists?
Common issues include missing applicability rationales, outdated standard references, weak links to supporting evidence, inconsistent terminology across documents, and gaps between the GSPR matrix and risk management or clinical evaluation files. Another frequent problem is citing documents that exist but do not fully support the claim being made. These weaknesses often trigger Notified Body questions and remediation work.
When should a manufacturer update its GSPR checklist?
A GSPR checklist should be updated whenever there is a significant design change, labeling revision, new test data, updated clinical evidence, revised standards, or changes to post-market findings that affect safety or performance claims. It should also be reviewed before Notified Body submission, surveillance activities, or technical documentation updates to ensure all references remain accurate and defensible.
Need Help With GSPR Documentation?
Talk with regulatory experts about your Annex I evidence strategy.
Global Service Coverage
Elexes supports medical device manufacturers across major regulated markets with remote and embedded regulatory consulting services.
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Service Reach
100+ Global Clients
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Remote & Embedded
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Certified & Trusted
Awards and Recognition
ISO 13485
Medical device quality system expertise.
MDSAP
Multi-market audit readiness support.
IEC 62304
Software lifecycle compliance capability.
