Postgraduate Diploma in MDR/IVDR: Conformity Strategy and Classification
Online 800-hour Postgraduate Diploma in MDR/IVDR: Conformity Strategy and Classification. 8 modules covering Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR) and EUDAMED. Assigned tutor and open enrolment.
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Run a real engineering trade-off from this programme. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Describe the European regulatory framework for medical devices and in vitro diagnostic medical devices.
Qualify and classify medical devices according to MDR Annex VIII.
Classify IVD devices according to the IVDR rules.
Select the appropriate conformity assessment route.
Structure technical documentation in line with Annexes II and III.
Plan the clinical and performance evidence required.
Design a regulatory strategy with post-market surveillance.
Who it's for
- Regulatory affairs specialist for medical devices who wants to specialise in MDR/IVDR: Conformity Strategy and Classification.
- Person responsible for regulatory compliance (PRRC) who wants to specialise in MDR/IVDR: Conformity Strategy and Classification.
- MDR/IVDR consultant who wants to specialise in MDR/IVDR: Conformity Strategy and Classification.
- Notified body auditor who wants to specialise in MDR/IVDR: Conformity Strategy and Classification.
- Clinical evaluation lead who wants to specialise in MDR/IVDR: Conformity Strategy and Classification.
- Post-market surveillance manager who wants to specialise in MDR/IVDR: Conformity Strategy and Classification.
- Engineering or science graduates looking to enter the medical device industry.
What you'll work with
- Regulation (EU) 2017/745 (MDR)
- Regulation (EU) 2017/746 (IVDR)
- MDCG 2021-24 (guidance on classification of medical devices)
- MDCG 2020-16 (guidance on classification of in vitro diagnostic devices)
- MDCG 2019-11 (qualification and classification of software)
- ISO 13485 (quality management of medical devices)
- ISO 14971 (risk management)
- ISO 20916 (clinical performance studies of IVD devices)
8 modules · 800 h
1.1From the MDD to Regulation (EU) 2017/7451.2Regulation (EU) 2017/746 on in vitro diagnostic medical devices1.3Transitional periods and Regulation 2023/6071.4Economic operators and their obligations1.5Notified bodies and their designation1.6MDCG Group and guidance documents1.7Harmonised standards and common specifications1.8Competent authorities and AEMPS1.9EUDAMED database1.10Case study: obligations map for a manufacturer and its importer
2.1Definition of medical device and accessory2.2Borderline products and MDCG 2022-5 guidance2.3Annex VIII: classification rules2.4Rules 1 to 22 and their interpretation2.5Rule 11 for medical software2.6MDCG 2019-11 guidance on software2.7Products without medical purpose in Annex XVI2.8Classes I, IIa, IIb and III2.9Procedure packs and kits2.10Workshop: justified classification of ten products
3.1Definition of in vitro diagnostic medical device3.2Seven classification rules of IVDR Annex VIII3.3Classes A, B, C and D3.4Companion diagnostics3.5Self-testing and near-patient tests3.6In-house devices3.7EU reference laboratories3.8MDCG 2020-16 guidance on IVD classification3.9In vitro diagnostic software3.10Practice: IVDR classification of a laboratory test panel
4.1MDR Annexes IX, X and XI4.2Assessment by risk class4.3ISO 13485 quality management system4.4Sampling-based assessment of technical documentation4.5Clinical evaluation consultation procedure4.6Expert panels for class III4.7Certificates and their validity4.8EU declaration of conformity and CE marking4.9Selection of the notified body4.10Case study: conformity route for a class IIb implant
5.1MDR Annexes II and III5.2General safety and performance requirements5.3Risk management ISO 149715.4Usability IEC 62366-15.5Software IEC 62304 and cybersecurity5.6Biocompatibility ISO 109935.7Labelling and instructions for use5.8UDI system and its assignment5.9Summary of safety and clinical performance SSCP5.10Workshop: checklist of general safety and performance requirements
6.1Clinical evaluation according to MEDDEV 2.7/1 rev. 46.2Equivalence with existing products6.3Clinical investigations ISO 141556.4IVDR performance evaluation6.5Scientific validity and analytical performance6.6Clinical performance of IVDs6.7IVDR performance studies6.8Post-market clinical follow-up PMCF6.9Orphan devices and legacy devices6.10Practice: clinical evaluation plan for a class IIa software
7.1Post-market surveillance system7.2PSUR report and PMS plan7.3Vigilance and reporting of serious incidents7.4Field safety corrective actions FSCA7.5Person responsible for regulatory compliance PRRC7.6Management of significant changes7.7Product regulatory strategy7.8Planning certification timelines and costs7.9Access to other markets: FDA and UKCA7.10Case study: regulatory strategy of a diagnostics start-up
8.1Product description and intended purpose8.2Justified qualification and classification8.3Selection of the assessment route8.4Technical documentation index8.5Clinical evidence strategy8.6Post-market plan8.7Timing and budget planning8.8Regulatory risk analysis8.9Report and presentation8.10Final review with the tutor
How you'll learn
100% online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. There are no fixed timetables: students progress at their own pace within the intake, which makes it possible to combine study with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is EUDAMED, Greenlight Guru, MasterControl, Jira, advanced Excel, in free, academic or evaluation versions. Case studies are based on real classification procedures for real products under the rules of Annex VIII, preparation of technical documentation files, and simulated notified body audits. Assessment is continuous by module, plus the final integrative project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Describe the European regulatory framework for medical devices and in vitro diagnostic medical devices.
Qualify and classify medical devices according to MDR Annex VIII.
Classify IVD devices according to the IVDR rules.
Select the appropriate conformity assessment route.
Structure technical documentation in line with Annexes II and III.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. A university degree is not required.
- Internet connection and a computer capable of running the programme's software.
- Sufficient level of Spanish to follow technical regulatory texts.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme totals 800 hours over 6 to 8 months. That is an average of 10 to 15 hours a week, compatible with a full-time job.
You will work with EUDAMED, Greenlight Guru, MasterControl, Jira and advanced Excel. Free, academic or evaluation versions are used, and the tutor indicates the open-source alternative where one exists.
SEIUM's own diploma, awarded on passing continuous assessment and the integrative project. This is in-house training, not an official Ministry title.
Yes. Modules passed in a course or postgraduate diploma in the same area are recognised in the advanced programme. Check the recognition policy when you complete your enrolment.
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