EU MDR 2017/745 Compliance Assessment

Evaluate compliance with European Medical Device Regulation 2017/745 covering device classification, quality management, clinical evaluation, post-market surveillance, and vigilance

MedtechHealthcareBiotech25 minutes21 questions

1. Device Classification & UDI

Have you correctly classified your medical device per Annex VIII (Class I, IIa, IIb, III)?*

MDR Article 51: Classification rules based on duration, invasiveness, and risk

Is your device registered in EUDAMED with UDI-DI assigned?*

Article 27: European Database on Medical Devices and Unique Device Identification

Do you maintain a UDI on device labels and all packaging levels?*

Article 27 & Annex VI Part C: UDI-DI on labels, UDI-PI for production identification

2. Quality Management System

Do you maintain an ISO 13485-compliant QMS covering all MDR requirements?*

Article 10: QMS must address design, manufacture, post-market surveillance

Is a person responsible for regulatory compliance (PRRC) designated?*

Article 15: PRRC must have expertise in regulatory affairs and QMS

Do you have risk management procedures per ISO 14971?*

Annex I (3): Risk management throughout device lifecycle

Are design controls and verification/validation documented per Annex I?*

General Safety and Performance Requirements: Design and manufacturing information

3. Technical Documentation

Is technical documentation prepared per Annex II or III (depending on class)?*

Article 10: Complete technical file required for conformity assessment

Does technical documentation include device description, design files, and manufacturing info?*

Annex II: Device description, labels, IFU, specifications, drawings, calculations

Are pre-clinical and clinical evaluation reports included in technical documentation?*

Annex II Section 4 & 6: Pre-clinical evaluation and clinical evaluation per Annex XIV

Is technical documentation maintained and updated throughout device lifecycle?*

Article 10(4): Documentation must be updated with post-market data and changes

4. Clinical Evaluation & Investigation

Is a clinical evaluation report (CER) prepared per Annex XIV?*

Article 61: CER demonstrating safety and performance through clinical data

Is the CER based on clinical investigations, literature review, or equivalence data?*

Annex XIV Part A: Sufficient clinical evidence from multiple sources

If conducting clinical investigations, are they registered in EUDAMED and approved by ethics committee?*

Article 62-80: Clinical investigation requirements, sponsor obligations

Is the CER updated with post-market clinical follow-up (PMCF) data?*

Article 61(11): Continuous clinical evaluation with PMCF plan

5. Post-Market Surveillance

Do you have a post-market surveillance (PMS) plan per Article 83-86?*

Article 83: PMS system to proactively collect and analyze data

Are Periodic Safety Update Reports (PSURs) prepared for Class IIb/III devices?*

Article 86: PSURs required at least annually or per notified body schedule

Do you maintain a post-market clinical follow-up (PMCF) plan?*

Article 61(11) & Annex XIV Part B: Continuous collection of clinical data

6. Vigilance & Safety Reporting

Are serious incidents reported to competent authorities within required timelines?*

Article 87: Immediate (deaths) or within 15 days (serious injuries)

Do you have procedures for Field Safety Corrective Actions (FSCAs) and Field Safety Notices (FSNs)?*

Article 89: Timely corrective actions and notification to users/patients

Are trend reports submitted when analyzing incident patterns?*

Article 88: Trend reporting for potential systematic issues

Please answer all required questions to see your results