Classify a medical device under EU MDR and select the appropriate conformity assessment route.
Healthcare & Pharmaceutical Management
Medical Device Regulatory Compliance Under EU MDR and FDA Pathways
Work through EU MDR and FDA regulatory pathways for medical devices: classify devices, build technical and clinical files, align quality systems, and manage UDI and post-market surveillance obligations.
🗓️Duration5 training days
📚Content4 modules · 8 sessions
🎓On completionAccredited attendance certificate
About the programme
Course Overview
A medical device submission stalls whenever classification, technical documentation and clinical evidence are prepared separately from the quality management system that has to support them long after launch. Regulatory and quality teams need one coherent method for working across EU MDR and FDA requirements rather than treating each market as an isolated project. This course opens with EU MDR classification rules and conformity assessment routes, then compares FDA premarket pathways, including predicate comparison and pre-submission strategy. Technical documentation sessions cover structuring files against Annex II and III requirements and building a risk management file with a documented risk-benefit analysis. Clinical evidence sessions address clinical evaluation planning under current guidance and designing a clinical investigation where evidence gaps require primary data. Quality system sessions align procedures with recognised quality management standards and cover software lifecycle processes for software as a medical device, including cybersecurity documentation. The course closes with Unique Device Identification, registration obligations and post-market surveillance planning, including vigilance reporting thresholds and periodic safety update reports.
Expected Learning Outcomes
Compare FDA premarket pathways and build a predicate comparison or clinical evidence strategy.
Structure technical documentation and a risk management file compliant with ISO 14971.
Plan a clinical evaluation or clinical investigation strategy aligned with current regulatory guidance.
Align quality management system procedures with ISO 13485 and prepare for regulatory audits.
Apply IEC 62304 software lifecycle and cybersecurity documentation requirements to device software.
Design UDI, EUDAMED and post-market surveillance processes that meet ongoing regulatory obligations.
Who Should Attend
Regulatory affairs specialists managing EU MDR or FDA submissions.
Quality assurance managers responsible for ISO 13485 quality management systems.
Clinical affairs staff planning clinical evaluation and post-market clinical follow-up.
Software engineering leads developing software as a medical device.
Post-market surveillance and vigilance reporting officers.
Medical device start-up founders preparing a first regulatory submission strategy.
Course Modules
Select any module to see its sessions and points.
01Regulatory Frameworks and Classification
2 sessions · 8 points
Session 1EU MDR Classification and Conformity Assessment Routes
- Classify a device under EU MDR Annex VIII rules based on duration, invasiveness and risk profile.
- Select the appropriate conformity assessment route and notified body engagement strategy.
- Assess implications of reclassification for legacy devices transitioning from a previous directive regime.
- Plan a compliance timeline accounting for notified body capacity constraints.
Session 2FDA Premarket Pathways
- Compare 510(k), De Novo and Premarket Approval pathways against device risk classification.
- Build a predicate device comparison table to support a substantial equivalence argument.
- Prepare a pre-submission meeting request to resolve pathway or testing uncertainty with the FDA.
- Plan submission timelines accounting for FDA review cycles and additional information requests.
02Technical Documentation and Clinical Evidence
2 sessions · 8 points
Session 1Technical Documentation and Risk Management Files
- Structure technical documentation against EU MDR Annex II and III requirements.
- Build a risk management file compliant with ISO 14971, including risk-benefit analysis.
- Document design verification and validation evidence linked to intended use claims.
- Maintain document version control and traceability across the technical file lifecycle.
Session 2Clinical Evaluation and Clinical Investigation Planning
- Plan a clinical evaluation strategy under current guidance, including literature and equivalence routes.
- Design a clinical investigation protocol where clinical data gaps require primary evidence.
- Coordinate post-market clinical follow-up planning as part of the overall clinical evidence strategy.
- Assess when equivalence claims to another device are defensible under current guidance.
03Quality Systems and Software Devices
2 sessions · 8 points
Session 1Quality Management System Alignment with ISO 13485
- Align quality management system procedures with ISO 13485 and applicable regional requirements.
- Coordinate design control procedures between development, regulatory and quality functions.
- Prepare for notified body or FDA quality system audits using internal audit and CAPA processes.
- Manage supplier and component qualification records within the quality management system.
Session 2Software as a Medical Device Compliance
- Apply IEC 62304 software lifecycle processes to software as a medical device development.
- Classify software safety class and define corresponding verification and documentation rigor.
- Manage cybersecurity risk documentation required for software and connected device submissions.
- Plan software change control and re-verification triggers for post-market updates.
04Market Surveillance and Post-Market Obligations
2 sessions · 8 points
Session 1Unique Device Identification and EUDAMED Registration
- Assign Unique Device Identification codes and structure data for EUDAMED registration.
- Coordinate economic operator registration obligations across manufacturers, importers and distributors.
- Maintain UDI database records through device design changes and packaging updates.
- Plan phased EUDAMED module compliance against current implementation timelines.
Session 2Post-Market Surveillance and Vigilance Reporting
- Design a post-market surveillance plan with defined data sources and review frequency.
- Establish vigilance reporting thresholds and timelines for serious incidents and field safety actions.
- Coordinate periodic safety update reports and trend reporting obligations.
- Investigate and document field safety corrective actions, including recall decision criteria.
What the participant receives
4 course modules
A structured syllabus
8 training sessions
across 5 days
32 detailed points
Applied, detailed content
Accredited attendance certificate
On completing the programme
Complete your registration
We will contact you within one business day to confirm.
Ready to start?
Reserve your seat and start building the skill.