Introduzione
Advertisement and Promotion Claims for Medical Devices
The EU Medical Devices Regulation (MDR 2017/745) has significantly changed the regulatory landscape for the MedTech industry, introducing new requirements in key areas such as stronger oversight by Notified Bodies (NBs) and Competent Authorities (CAs), Enhanced General Safety and Performance Requirements, increased transparency and publicity of clinical and other data and Scrutiny of advertisement and promotional claims.
In addition, national regulations impose specific rules on device advertising, prior approval requirements, and transparency in interactions with healthcare professionals (HCPs).
This course provides participants with a clear understanding of the laws and regulations governing marketing and promotion of medical devices in the EU, helping sales, marketing, and regulatory professionals to ensure compliance when interacting with HCPs and the public, establish effective claims and marketing compliance processes and understand the consequences of violating advertisement laws.
Participants will gain answers to critical questions, including:
- How are EU markets structured, and which authorities supervise marketing and promotion?
- What laws and guidance documents apply to my promotional activities?
- How will marketing materials be scrutinized by CAs and NBs?
- What constitutes a sound basis for marketing and promotion claims?
- How to ensure release processes at corporate and regional levels for multi-country promotions?
- Master storybook – how to translate regulatory requirements from raw data into strategic claims.
- Can professional-use devices be promoted to the public? When is a doctor’s check required?
- How does reimbursement status affect promotion capabilities?
- What are the risks of mislabeling or false advertising?
- What are the responsibilities of the manufacturer and economic operators?
- What qualifications do sales professionals need to comply with in some countries?
- Which transparency rules must be followed?
Programme
The training combines regulatory insights, practical guidance, and case studies to help participants navigate the complex rules around medical device promotion in the EU.
Part 1: Introduction to Advertisement regulations for medical devices
- The EU market and lawmaking process
- Regulatory framework impacting marketing and promotion
- Claims regulations in the EU – Common principles
- Risks of false claims and unlawful advertising
- National laws and guidance documents
- Is comparator advertising allowed?
- Case studies & Take aways
Part 2: Claims and Advertising
- The role of the technical dossier for claims and advertising: company roles, notified body, and competent authority involvement
- Dos and don’ts for claims and event management
- Communication and control processes – Creating a master storrybook
- Types of claims and the data required to support them
- Examples: Laws in UK, France, Spain, Italy
- Case studies
Recap and Q&A
- Summary of key takeaways
- Interactive question and answer session
This course is designed for professionals involved in the marketing, promotion, and compliance control of medical devices, including:
- Marketing and sales staff responsible for product promotion.
- Company managers overseeing commercial and compliance activities.
- Quality, Regulatory, and Clinical Managers ensuring adherence to MDR and national regulations.
- Other company personnel with responsibility for marketing compliance, claims management, or interactions with healthcare professionals.
By attending, participants will gain practical knowledge and tools to ensure compliant marketing and advertising practices across the EU.
Participant experience
Basic knowledge of Medical Devices regulations would be of help.
This is an online training that combines frontal lessons with interactive Q&A sessions.
Docente/i
Arkan Zwick
Mr. Arkan Zwick is Corporate Regulatory Affairs Director at a global pharmaceutical and surgical company active in ophthalmology, orthopedics, and aesthetic dermatology. With over 20 years of regulatory experience, he oversees EU compliance with notified bodies and manages global market authorizations across the Americas and Asia-Pacific. His expertise spans regulatory advocacy for drugs, medical devices, combination products, and cosmetics, as well as legal counsel on contracts, mergers & acquisitions, and intellectual property. Arkan holds a master’s degree in law and a PhD in European Law from the University of Vienna. He lectures at University of Applied Sciences (IMC Krems) and speaks regularly at international conferences.
This online training consists of 1 module:
08 April 2027 from 2:00 pm to 6:00 pm CEST
Some days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 490,00* (until 18 March 2027)
Ordinary: € 620,00*
Freelance – Individual – Academy – Public Administration: € 390,00*
* for Italian companies: +22% VAT
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
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Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.