3-Day Offline EU MDR Training by AptSkill

Join AptSkill's intensive 3-day offline EU MDR training in India. Hands-on sessions on classification, technical documentation, clinical evaluation, and Notified Body readiness for MedTech teams.

Building In-House EU MDR Expertise for the European Market

EU MDR 2017/745 fundamentally changed what it takes to place a medical device on the European market. Compared to the earlier MDD framework, MDR demands far more rigorous clinical evidence, deeper technical documentation, continuous Post-Market Surveillance, and closer scrutiny from Notified Bodies. Companies that treat MDR as a one-time compliance exercise — rather than a lifecycle discipline — routinely face documentation gaps, delayed Notified Body audits, or certificate renewal setbacks.

Most teams discover these gaps only when a Notified Body flags them. AptSkill's 3-day offline EU MDR training is built to close those gaps proactively, inside your organization, well before your next audit or submission.

This is a working, document-heavy workshop — not a lecture series. Your team leaves having actually built classification decisions, reviewed technical documentation structure, and worked through a mock Notified Body audit for your own product.

Why a Dedicated 3-Day Format?

EU MDR compliance touches regulatory strategy, quality systems, clinical evidence, risk management, and post-market obligations all at once. A single half-day session leaves teams with theory but no practical skill. Our 3-day structure is built to fix that:

• Day 1 — Build strong foundations: classification, regulatory strategy, and QMS alignment

• Day 2 — Go deep into technical documentation, clinical evaluation, and risk management

• Day 3 — Apply everything through mock audits, PMS/vigilance simulation, and Q&A specific to your product

Teams leave with a working documentation roadmap for their own device, not just a set of slides.

3-Day Training Agenda

Day 1: Foundations, Classification & Regulatory Strategy

• EU MDR 2017/745 overview: scope, structure, and key changes from MDD

• Classification rules (Annex VIII) and their impact on conformity assessment route

• Economic operator roles and responsibilities: Manufacturer, Authorised Representative, Importer, Distributor

• Notified Body selection and engagement strategy

• Transition timelines and legacy device considerations

• Workshop: classifying your own product(s) under MDR Annex VIII

Day 2: Technical Documentation, Clinical Evaluation & Risk Management

• Technical Documentation structure (Annex II & III) — building a compliant file

• Clinical Evaluation Reports (CERs): literature review, equivalence, and clinical evidence strategy under MEDDEV 2.7/1 Rev 4

• Risk management file requirements per ISO 14971, aligned to MDR General Safety and Performance Requirements (GSPRs)

• Usability engineering documentation (IEC 62366-1) and software documentation (IEC 62304), where applicable

• UDI assignment and EUDAMED registration requirements

• Hands-on exercise: mapping GSPR compliance for your own device

Day 3: PMS, Vigilance, Mock Audit & Certification Readiness

• Post-Market Surveillance (PMS) plans, PSURs, and PMCF (Post-Market Clinical Follow-up) strategy

• Vigilance reporting: incident classification, timelines, and FSCA management

• Common Notified Body findings and how to avoid them

• Mock Notified Body audit simulation: role-play and documentation critique

• Open case study session using participant company products

• Certificate renewal and ongoing compliance maintenance

• Q&A, gap analysis, and personalized MDR compliance roadmap

Who Should Attend

• Regulatory Affairs and Quality Assurance teams managing EU market compliance

• R&D and engineering teams supporting technical documentation

• Clinical and medical affairs teams responsible for clinical evidence generation

• Startups preparing their first EU MDR technical file

• Established manufacturers transitioning from MDD, renewing certificates, or facing Notified Body findings

Fully Customizable to Your Product Portfolio

While the 3-day structure above is our recommended flow, every session is tailored before delivery:

• Product-specific classification and GSPR mapping using your actual device and intended use

• Focus area selection (initial certification, MDD-to-MDR transition, or certificate renewal/maintenance)

• Depth adjustment based on whether your team is early-stage or already managing an active Notified Body relationship

• Flexible group size and venue — delivered at your facility or a location of your choice, anywhere in India

• Optional add-on modules, such as IVDR overview for combination portfolios, SaMD-specific MDR considerations, or PMCF study design

Before the training, AptSkill conducts a pre-session scoping call with your team to align the agenda, exercises, and case studies with your specific device and compliance priorities.

What Your Team Walks Away With

• A working MDR classification decision for your own product(s)

• A clear map of Technical Documentation and GSPR requirements specific to your device

• Practical understanding of clinical evaluation and PMS/vigilance obligations

• Hands-on experience through a mock Notified Body audit simulation

• A personalized gap analysis and MDR compliance roadmap for next steps

Why AptSkill

AptSkill brings deep, hands-on regulatory affairs expertise across the full MedTech spectrum — including EU MDR, IVDR, ISO 13485, ISO 14971, and FDA 21 CFR 820 — combined with a strong track record of building practical, in-person training programs for MedTech companies across India. Our trainers don't just explain the regulation; they help your team apply it to your own product, in the room, in real time.

Book Your 3-Day EU MDR Training

Ready to build real in-house EU MDR compliance capability for your team? Get in touch with AptSkill to schedule your customized 3-day offline training.

📧 Email: aptskill6@gmail.com 📞 Phone: +91 8262083746