IVDR Compliance Templates
Professional, expert-crafted templates to accelerate your EU In Vitro Diagnostic Regulation compliance. Save weeks of preparation time.
Technical Documentation Templates
Comprehensive templates for IVDR technical documentation, including technical files, GSPR checklists, and device description documents.
IVDR Technical File Template Package
Complete set of templates for compiling your IVDR technical file, including device description, design documentation, and manufacturing information sections. Covers all Annex II and III requirements.
GSPR Compliance Checklist (Annex I)
Detailed checklist covering all General Safety and Performance Requirements of IVDR Annex I. Includes guidance notes and cross-references to harmonised standards.
Device Description Document Template
Structured template for documenting your IVD device description as required by IVDR Annex II. Covers intended purpose, principles of operation, and device variants.
IVDR Templates
Essential IVDR-specific templates covering declarations of conformity, labelling requirements, and regulatory submissions.
Complete IVDR Compliance Bundle
All-in-one bundle containing 18+ templates covering technical documentation, QMS, performance evaluation, and post-market surveillance. Best value for comprehensive IVDR compliance.
EU Declaration of Conformity Template
IVDR-compliant EU Declaration of Conformity template with all required elements per Article 17 and Annex IV. Includes guidance for proper completion.
IVD Labelling & IFU Template Set
Templates for creating IVDR-compliant labels and Instructions for Use (IFU). Covers all labelling requirements from Article 10 and Annex I Chapter III.
Post-Market Surveillance Plan Template
Comprehensive PMS plan template aligned with IVDR Article 78 requirements. Includes proactive and reactive surveillance activities, data sources, and reporting timelines.
QMS Templates
Quality Management System documentation templates aligned with ISO 13485 and IVDR requirements for IVD manufacturers.
QMS Documentation Suite for IVDR
Complete Quality Management System documentation package with 23 templates aligned to ISO 13485:2016 and IVDR requirements. Covers quality manual, SOPs, work instructions, and forms.
Risk Management File Template (ISO 14971)
Complete risk management file template aligned with ISO 14971:2019 and IVDR requirements. Includes risk management plan, FMEA worksheets, and risk management report.
CAPA Procedure & Forms Template
Corrective and Preventive Action procedure template with associated forms. Aligned with ISO 13485 Clause 8.5.2/8.5.3 and IVDR vigilance requirements.
Validation Plans & Reports
Performance evaluation plans, validation protocols, and report templates for IVD device compliance under IVDR.
Performance Evaluation Report Template
Comprehensive template for documenting your IVD performance evaluation per IVDR Annex XIII. Covers scientific validity, analytical performance, and clinical performance assessment.
Performance Evaluation Plan Template
Structured plan template for defining your IVD performance evaluation strategy. Includes study design considerations, statistical methodology, and acceptance criteria.
Clinical Performance Study Protocol Template
Protocol template for planning clinical performance studies under IVDR Article 58. Covers study objectives, design, endpoints, statistical analysis plan, and ethical considerations.
IVD Software Validation Plan & Report
Validation plan and report templates for IVD software, covering IEC 62304 lifecycle processes and IVDR-specific requirements for software as a medical device (SaMD).
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