Borderline and Classification of medical devices
Dates TBD

Borderline and Classification of medical devices

English | 
Learn to classify medical devices in compliance with EU regulations. Understand borderline cases. 4-hour session for medical device professionals and developers.

To determine if a specific product adjusts to the definition of medical device and in order to apply the relevant classification rules a crucial step is to guarantee the safety and the compliance of the applicable European regulations.

The developers and/or manufacturers of medical devices must be well instructed on the regulations that govern the medical technology industry, as well as comprehend the classification rules stablished for the correct qualification and classification of their products.

The training course “Borderline and Classification of medical devices” teaches the participants to discern the fine line that separates medical devices from those that are not, and to dominate the ins and outs of the classification of the products, guaranteeing a precise categorization and the proper compliance of the regulation.

  • Introduction to the regulation of medical devices: MDR and IVDR.
  • Qualification as medical devices and in vitro diagnostic medical devices.
  • Borderline devices: Medicines, biocides, cosmetics, food products, personal protective equipment, substances of human origin.
  • Classification of medical devices.
  • Classification of in vitro medical devices.
  • New technologies: Software.

Aimed at professionals in the medical device industry or other products; medical device developers and/or anyone who wants to understand the legislative framework that applies to medical devices in the European Union. No prior knowledge is required.

Adi Ickowicz, BSc, ME
Senior Principal at the MedTech Unit of Asphalion

With over twenty-five years in the MedTech industry, Adi’s extensive background includes leadership roles in regulatory affairs, clinical, and quality assurance departments across both well-established firms and start-ups. Additionally, he is a lecturer in various academic institutions.


Talyta Carteano
Medical Devides director

Over 10 years’ experience in the Medical Device Industry, as well as experience as R+D Project Manager focused on the development of Mechanical and Electronic Medical Devices.

Expertise in developing, controlling and auditing Quality Management Systems in accordance with ISO 13485 and in IVD self- testing.

Scientific assessment in development of innovative medical devices; due diligence of registration dossiers; writing of regulatory documentation (technical files, FDA clearance.); life cycle maintenance; project and team management.

Leading expert and lecturer in the new Medical Device (MD) and In Vitro Medical Device (IVD) Regulation.  Working as expert in the preparation of Regulatory Roadmaps and regulatory strategy for complex MD and IVD.

Regulatory Work Package Manager of H2020 projects.

The course is delivered in a 4-hour session.

Price: 400€

Early Bird: 10% discount up to 30 days before training date.

Information request

Interested in our course?

Please fill out the form below, and we’ll get in touch with you shortly to provide more information or secure your spot.

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting