IVDR Regulatory and Clinical Writing for In Vitro Diagnostics
PERs, SVRs, CPRs, APRs, IFUs, GSPRs, SSPs and the supporting submission package — authored by a dedicated team of medical writers and credentialed medical librarians supporting global IVD submissions to the FDA, Health Canada, EU notified bodies under IVDR, and regulators across the UK, Asia-Pacific, and Latin America.
100
PERs and SVRs Authored
650
Systematic Literature reviews completed
10 years
Specialized regulatory writing since 2016
Every IVD document on your submission checklist.
Our team of experienced writers and medical librarians specialize in creating high-quality, compliant documentation essential for regulatory submissions and scientific communications.
Regulatory & Clinical Writing
- Performance Evaluation Reports (PER)
- Scientific Validity Report (SVR)
- Clinical Performance Reports (CPR)
- Analytical Performance Reports (APR)
- Instructions for Use (IFU)
- Regulatory Submissions (FDA, IVDR, MHRA, Health Canada, ANVISA, COFEPRIS & more)
- Notified Body Deficiency Responses
- Post-Market Surveillance Plans (PMS)
Systematic Literature Reviews
- Search & Screening Strategy
- PRISMA Flowcharts & Methodology
- Evidence Writing & Appraisal
- Literature Review Reports
- Data Extraction Tables & Analyses
- Yearly Surveillance Literature Reviews
- Executive Summary of Findings
Scientific and Technical Documentation
- Companion Diagnostics (CDx) Writing Support
- Performance Evaluation Documentation
- Risk Analysis & Management Documents
- Regulatory Document Gap Analysis
- Template Review and Development
- Acceptance and Performance Measures
- Summary of Safety and Performance
- GSPR Conformity Documentation (IVDR Annex I)
Don’t see the deliverable you need? Our team has authored 70+ document types across the IVD lifecycle.
Therapeutic areas where our IVD writing has reached submission.
Criterion Edge has authored regulatory and clinical documentation across the full breadth of IVD clinical applications — from infectious disease syndromic panels to companion diagnostics for oncology therapeutics.
Infectious Disease
IVDR Class B–D
- Respiratory pathogen panels
- Gastrointestinal pathogen panels
- Antimicrobial resistance and susceptibility
- Bloodstream infection and sepsis
- Sexually transmitted infections
Oncology and Companion Diagnostics
IVDR Class C
- Solid tumor biomarkers (BRAF, EGFR, KRAS)
- HER2, PD-L1 IHC
- Therapy-paired CDx submissions
- Liquid biopsy and circulating tumor DNA
- Hereditary cancer panels
Autoimmune Disease
IVDR Class B–C
- Autoantibody and serology panels
- Allergy-specific IgE testing
- Transplant compatibility (HLA)
- Rheumatology markers (RF, CCP, ANA)
- Immunodeficiency screening
Cardiovascular Disease
IVDR Class B–C
- Troponin and cardiac markers
- Acute kidney injury biomarkers
- Coagulation and thrombosis
- Heart failure biomarkers (BNP, NT-proBNP)
- Procalcitonin and sepsis triage
Genetics and Molecular Diagnostics
IVDR Class C
- NGS-based panels & whole exome
- Hereditary disease screening
- Rare disease diagnostics
- Pharmacogenomics
- Prenatal & carrier testing
Metabolic Disorders
IVDR Class B
- Diabetes (HbA1c, glucose monitoring)
- Reproductive hormones
- Lipid & cholesterol assays
- Thyroid function panels
- Vitamin D & bone metabolism
Hematology & Blood Banking
IVDR Class B–D
- Complete blood count interpretation
- Blood typing & crossmatch
- Coagulation factor assays
- Hemoglobinopathies
- Transfusion-transmitted infections
Reproductive Medicine
IVDR Class B–C
- HPV genotyping & cervical cancer screening
- Prenatal screening (NIPT)
- Menopause & reproductive hormones
- Pregnancy & fertility testing
- STI screening
Typical IVDR risk class shown per Annex VIII rules and MDCG 2020-16 rev.4 (March 2025). Final classification depends on the device’s intended purpose — we confirm the exact rule and class for your device during scoping.
Don’t see your therapeutic area? We routinely take on adjacent and emerging IVD categories.
Roughly 80% of IVDs now require notified body review — up from approximately 10% under the previous IVD Directive.
EU Regulation 2017/746 (IVDR) raised the bar for every diagnostic device on the market. Where the old IVDD allowed self-declaration for most devices, IVDR forces a documentation-heavy, evidence-driven Performance Evaluation across three pillars — scientific validity, analytical performance, and clinical performance. Notified body queues are long, deficiency letters are common, and a single missing piece of evidence can delay launch by months.
Our writers don’t just know the regulation. They know which sections of the technical documentation a notified body actually scrutinizes — the GSPR conformity demonstration and the Performance Evaluation itself — and how to assemble the surrounding evidence so reviewers don’t bounce it back.
Class C and D bottleneck
Most companion diagnostics, infectious disease, and self-test devices now require full IVDR conformity — analytical and clinical performance, scientific validity, GSPR demonstration, and notified body sign-off. The PER is one report inside a much larger package, and notified body capacity is the binding constraint — clean, complete documentation moves through faster
SOTA is the silent failure point
SOTA is the foundation everything else builds on — clinical performance, analytical performance, and scientific validity all reference it. An outdated literature search, missing alternative-device benchmark, or thin justification for clinical equivalence weakens the entire submission. We treat SOTA as systematic literature work, not a narrative.
The PMS lifecycle never closes
IVDR requires continuous post-market activity — surveillance (Articles 78–81) and performance follow-up (Annex XIII, Part B). We build PMS plans and PMPF protocols designed to feed clean data back into PER updates, not sit in a drawer until the next audit.
Regulatory authorities our IVD documentation has reached.
Tell us yours during scoping — we’ll align documentation style and depth before the first draft.
Europe — Notified Bodies Under IVDR
BSI (Netherlands & UK) · TÜV SÜD (Germany) · DEKRA (Netherlands) · SGS (Belgium)
North American and United Kingdom
FDA (United States) · Health Canada (Canada) · MHRA (United Kingdom)
Latin America
ANVISA (Brazil) · INVIMA (Colombia) · COFEPRIS (Mexico) · SENASA (Argentina) · DIGEMID (Peru)
Asia-Pacific
KTL (South Korea) · JQA (Japan) · NIH (Malaysia) · CNIS (China)
A methodology built for documents that get audited.
Our IVD writing process is documented, version-controlled, and audit-ready. Quality control is not the last step — it is in every step.
Project Scoping & Planning
- Define the scope of the project
- Outline timelines for deliverables
- Clarify roles and responsibilities
- Establish communication channels with SMEs
Document Development
- Focused document development
- Proactive timeline management
- Collaborative engagement with stakeholders/SMEs
Review Process
- Roundtable leadership
- Management of action items
- Structured review reminders
Finalization & Delivery
- Client-tailored close out process
The team that does the work
Each writer below has direct, hands-on industry experience — not just regulatory awareness. They’ve sat in your seat, in companies like yours, and know what a notified body deficiency letter actually looks like
Laurie Mitchell, MN
President & Founder
Founded Criterion Edge in 2016 to build a specialist regulatory writing firm. Sets methodology, quality standards, and writer development across the IVD, Medical Device, and Pharma/Biologics teams.
Sarah Chavez, PhD
Director, IVD & Scientific Writing Services
Director of IVD and Scientific Writing Services since 2022, originally joining Criterion Edge as Principal Medical Writer in 2018. PhD in Molecular and Cellular Biology. Brings twenty years of benchtop molecular biology experience and a teaching background in genetics, biochemistry, and biology to IVDR-ready technical documentation.
Stephanie Knighten
Director, Medical Device
Twenty-one years of experience across medical device, nonclinical, and clinical regulatory writing. Specializes in EU MDR strategy and MEDDEV guideline compliance. Proven leader of medical writing teams delivering compliant submissions for medical device and pharmaceutical clients alike.
Emily Garcia, PhD
Director of Pharmaceutical Writing
Emily brings 18 years of pharmaceutical and medical device experience, specializing in clear, high-quality clinical and regulatory documents. She has led writing teams, improved processes, and supported organizations of all sizes throughout the product lifecycle.
Extended team
Medical librarians & specialist writers
A wider bench of credentialed medical librarians, scientific writers, and contract specialists scaled to your timeline. Same QC standards across every project — full team introductions during scoping.
Specialized IVD writing vs. a generalist CRO
Many of the largest CROs do excellent clinical operations and middling medical writing — because writing is one offering inside a hundred. We do this and only this.
IVDR Annex XII expertise
Generalist CRO: Often delegated to junior staff
Criterion Edge: Lead authors with IVDR-specific experience
Notified body familiarity
Generalist CRO: Variable by team assigned
Criterion Edge: BSI, TÜV SÜD, DEKRA, SGS
SOTA & SV literature work
Generalist CRO: Often outsourced or thin
Criterion Edge:Credentialed medical librarians, PRISMA-compliant
Aggressive timeline accommodation
Generalist CRO: Slot-based, queue-bound
Criterion Edge: Flexible staffing scaled to your deadline
Pricing transparency
Generalist CRO: Master service agreements, change orders
Criterion Edge: Clear scoped quotes, no budget surprises
Specialist focus
Generalist CRO: One offering of many
Criterion Edge:Regulatory and medical writing only
Generalist CRO
Criterion Edge
IVDR Annex XII expertise
Often delegated to junior staff
Lead authors with IVDR-specific experience
Notified body familiarity
Variable by team assigned
BSI, TÜV SÜD, DEKRA, SGS
SOTA & SV literature work
Often outsourced or thin
Credentialed medical librarians, PRISMA-compliant
Aggressive timeline accomodation
Slot-based, queue-bound
Flexible staffing scaled to your deadline
Pricing transparency
Master service agreements, change orders
Clear scoped quotes, no budget surprises
Specialist focus
One offering of many
Regulatory and medical writing only
What our clients have to say
Survey Responses
Below are the average scores (out of 5) for each of the criteria we ask our clients to grade us on after every project.
/ 5.00
Frequently Asked Questions
What is a Performance Evaluation Report (PER) under IVDR?
A Performance Evaluation Report (PER) is the central clinical evidence document required for CE marking of an IVD under EU Regulation 2017/746 (IVDR). It integrates three pillars of evidence — Scientific Validity (SV), Analytical Performance, and Clinical Performance — into a single document that demonstrates conformity with the General Safety and Performance Requirements (GSPR). Per IVDR Annex XIII, the PER must be updated throughout the device lifecycle and is reviewed by the notified body during conformity assessment for Class B, C and D devices.
What is the difference between a Scientific Validity Report and a State of the Art (SOTA) report?
A Scientific Validity Report (SVR) demonstrates the association between an analyte and a clinical condition or physiological state — answering “does measuring this analyte correctly identify the target condition?”. A State of the Art (SOTA) report establishes the current accepted clinical practice, alternative diagnostic methods, and benchmark performance against which the subject device is compared. Both are required components of a PER under IVDR Annex XIII, and both rely heavily on systematic literature review using PRISMA methodology.
Which notified bodies has Criterion Edge worked with for IVDR submissions?
Criterion Edge has authored documentation for IVDR submissions reviewed by major EU notified bodies including BSI, TÜV SÜD, DEKRA, and SGS. Our writers are familiar with each notified body’s documentation style, common deficiency themes, and review priorities.
Which regulatory authorities and jurisdictions does Criterion Edge support?
Criterion Edge supports IVD submissions globally. We have authored documentation reaching the FDA (510(k), De Novo, PMA, IDE) in the United States, Health Canada, EU notified bodies under IVDR, the MHRA in the UK, ANVISA in Brazil, INVIMA in Colombia, COFEPRIS in Mexico, SENASA in Argentina, DIGEMID in Peru, and certification bodies across Asia-Pacific including KTL (South Korea), JQA (Japan), NIH (Malaysia) and CNIS (China). Many of our clients require parallel global submissions, and our writers structure documentation to maximize content reuse across jurisdictions while respecting the structural and evidentiary differences each regulator expects.
How do you structure documentation for parallel submissions in multiple jurisdictions?
We treat the IVDR Performance Evaluation Report and the FDA technical file as the two anchor documents and map shared evidence into a master source library. From there, jurisdiction-specific deliverables are built as views into that library — an SSP for EU, a 510(k) summary for FDA, an MDL submission for Health Canada, ANVISA registration sections for Brazil, and so on. This minimizes duplicate writing while letting each submission read natively to its target reviewer. Where harmonization initiatives apply (MDSAP, IMDRF Table of Contents), we align documentation accordingly.
What is a SOTA in IVD regulatory writing?
SOTA stands for State of the Art. In IVD regulatory writing under IVDR, the SOTA section of a Performance Evaluation Report establishes the current accepted clinical practice, available alternative devices, and benchmark performance characteristics for the target condition. It provides the comparative context against which the subject device’s performance is evaluated. SOTA is built primarily through systematic literature review using PRISMA methodology and is one of the most common sources of notified body deficiencies when not done rigorously.
How long does it take to write a Performance Evaluation Report?
A Performance Evaluation Report typically takes 8 to 16 weeks for a Class B or C IVD with complete source data, and 14 to 24 weeks for Class D devices or those requiring extensive systematic literature review. Criterion Edge offers expedited timelines through scaled writer teams; we have delivered PER drafts in as little as 6 weeks for clients with submission deadlines. Timeline varies significantly based on completeness of source data, intended-use complexity, and notified body alignment.
What is the GSPR and do you provide GSPR documentation?
The GSPR (General Safety and Performance Requirements) is the IVDR Annex I list of essential requirements that every IVD must meet for CE marking. GSPR documentation is typically presented as a checklist mapping each applicable requirement to the evidence demonstrating conformity. Criterion Edge provides GSPR checklist authoring and review through our regulatory writing partner network; for GSPR-only projects we recommend pairing with our PER and SSP services so the cross-references stay tight.
Can Criterion Edge handle aggressive submission timelines?
Yes. Criterion Edge maintains a flexible staffing model that scales writer teams to match urgent client timelines, including parallel writing tracks for multi-document submissions. We have hit 6-week PER drafts and 1-week notified body deficiency response turnarounds when needed. Discuss your deadline during scoping and we will structure a delivery plan around it — including bringing on vetted contract writers from our extended network where appropriate.
What is the difference between IVDR and the previous IVD Directive?
EU Regulation 2017/746 (IVDR) replaced Directive 98/79/EC (IVDD) and has applied since 26 May 2022. Following Regulation (EU) 2024/1860 (in force 9 July 2024), the extended transition deadlines for legacy IVDs are 31 December 2027 for Class D, 31 December 2028 for Class C, and 31 December 2029 for Class B and Class A sterile devices; Class A non-sterile devices must already be IVDR-compliant. Key regulatory changes include: a risk-based classification system (Class A through D) instead of list-based self-declaration; mandatory notified body involvement for roughly 80% of IVDs (versus approximately 10% under IVDD); formal Performance Evaluation requirements per Annex XIII; public Summary of Safety and Performance (SSP) documents for Class C and D devices; and significantly expanded post-market obligations.
TALK TO AN EXPERT
Whether you’re navigating a complex regulatory submission, preparing for an audit, or simply exploring outsourced support — our team is here to help.
Criterion Edge specializes in high-quality, compliant medical writing services for the life sciences industry. Use the form to tell us a bit about your needs — one of our experts will follow up within one business day.
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- No obligation — just an open conversation
- Expert guidance from PhD-level writers
- Trusted by leading MedTech & Pharma companies
- Fast turnaround for time-sensitive projects
- Clear quotes and scoping available