EU MDR Regulatory Review Packages
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EU MDR Regulatory Review Packages
Advisory services are opening in 2027. The packages below represent the scope of work that will be available at launch.
If you would like to be notified when services open, or to discuss your documentation needs in advance, you can reach out via the contact form.
Literature Search Strategy Design
MDR-compliant literature search protocol development
Scope: Search strategy, PICO framework, keyword definition
Delivery: 3–5 business days
What you will receive:
- Structured literature search protocol (CEP-aligned)
- Database-specific keyword strategy (PubMed, Cochrane, etc.)
- Inclusion and exclusion criteria
- Search methodology documentation
Systematic Literature Search & Screening
Comprehensive literature identification and selection
Scope: Scientific databases and vigilance data sources
Delivery: 5–7 business days
What you will receive:
- Literature search results (PubMed, Cochrane, etc.)
- Title & abstract screening
- Full-text article selection
- Structured article list (Excel format)
State of the Art (SoTA) Analysis
Definition of current clinical practice and benchmark technologies
Scope: Clinical guidelines, alternative treatments, comparable devices
Delivery: 5–7 business days
What you will receive:
- State of the art analysis
- Identification of alternative treatment options
- Benchmark comparison with existing technologies
- Clinical practice overview
NB-Ready CER Express Review
Independent MDR Annex XIV Clinical Evaluation Review
Scope: Clinical Evaluation Report (CER)
Delivery: 5 business days
What you will receive:
• MDR Annex XIV alignment review
• Structured deficiency list
• Risk flag summary
• Submission-readiness commentary
All review requests are handled confidentially and independently.
Technical Documentation Compliance Review
Independent Annex II & III Technical File Assessment
Scope:
Full technical documentation review according to MDR Annex II & III.
What you will receive:
- Structured compliance gap analysis
- Risk management documentation assessment (EN ISO 14971 alignment)
- GSPR consistency review (Annex I)
- Classification & rule verification (Annex VIII)
- Structured deficiency list ready for internal correction
- Executive compliance summary
