Master Medical Devices Registration in European Union by EMA

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About Course

🚀 Learn how to navigate medical device registration in the European market and understand the role of the EMA in ensuring product safety and compliance.
📚 Discover key regulatory pathways, clinical trials, pharmacovigilance, and essential standards like GMP, GCP, and GVP.
🌍 Gain practical strategies to accelerate approvals and unlock opportunities in one of the world’s largest healthcare markets.
🎯 Build real-world regulatory expertise to advance your career in pharma, medical devices, and healthcare.

What Will You Learn?

  • Get introduced to EMA
  • Master EMA portal
  • Master Medical Devices Registration in Europe
  • Master Medical Devices Classification in Europe
  • Master regulatory harmonization across Europe
  • Keep an eye on the updates and each country's response
  • Master both the Centralized and Decentralized processes of Registration
  • MHRA, TGA, and FDA situation and response from EMA
  • Master products: Importation, renewal, and variation
  • EUDAMED database
  • EUDRAVIGILANCE
  • Shifting to MDR
  • In this course, we will cover all topics related to medical devices in Europe, starting from the requirements, interim regulations, classification, verification, and special conditions. we will get introduced to EMA committees:
  • Committee for Medicinal Products for Human Use (CHMP) – Reviews and approves new medicines.
  • Pharmacovigilance Risk Assessment Committee (PRAC) – Monitors drug safety.
  • Committee for Orphan Medicinal Products (COMP) – Manages rare disease treatments.
  • Committee for Advanced Therapies (CAT) – Assesses gene and cell therapies.
  • Will explore together EMA regulatory pathways and how to choose the best one suitable for the product
  • Centralized Procedure (mandatory for biotech, orphan, and advanced therapies)
  • Decentralized Procedure (for medicines not covered by the centralized route)
  • Mutual Recognition Procedure (MRP) (approval in one EU country extended to others)
  • National Procedure (only applicable in a single EU member state)
  • Then we will go deeper to see the actual forms, and templates as usual I keep the theme of the Pharma Academy that it comes to you "From Practice", and prepare the submission dossier together, and ensure its verification, of the medical, and interact with the actual MHRA gateway for the submission. 
  • and we will end our journey by landing the department of custom clearance, tracking /tracing system, barcoding, and 2DMatrix for all the shipments planned for the European market importation.
  • And finally, congratulations to you for mastering medical device registration in the European market, and see you soon in the pharma industry, my dear colleagues.

Course Content

Module 1: Introduction
In this section, we will be introduced to the European market of medical devices, will be introduced to the EMA, listing the topics that we will cover together as long as we go further in our course

  • Introduction
    08:00

Module 2:Definition
In this section we will start our journey with EMA by the medical device's definition, as a starting point towards classification and later on registration

Module 3:EMA regulatory pathway
In this section, we will explore together the EMA regulatory pathway for medical devices

Module 4:Borderline products
In this section, we will practice the category of medical devices that has always been a topic of conflict, the borderline and combined products

Module 5:The Stakeholders
In this section we will explore the stakeholders for medical devices covering all its possibilities

Module 6:EMA MD Regulations
In this section we will master the updated regulations of medical devices regulatory activities issued by EMA

Module 7: CE Mark
In this section we will master the core topic and certificates of any medical device, which is the CE certificate, which is the outcome of the conformity Massenet process

Module 8: Free Sale Certificate
In this section we will manage medical devices registration outside Europe, while the COO of those medical devices is Europe, we will master how to align EMA requirements with the global ones

Module 9: New EMA regulations
In this section we will come up with updated regulations of EMA for the medical devices

Module 10: System/procedure packs
In this section we will master a very interesting topic of combined products, and possibility to group as a kit or not, we will master the System/procedure packs

Module 11: Tracking/Tracing
In this section we will cover the tracking and tracing of shipments in Europe, via exploring all possible options of coding

Module 12: EUDAMED
In this section we will end up our interesting journey with EMA, with the EUDAMED medical devices listing database

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