Introduzione
The EU Regulation on Medical Devices 2017/745 (MDR) significantly changed the landscape for the medical device industry.
The Regulation introduced novel requirements in critical areas such as stronger Notified Body (NB) and Competent Authority (CA) oversight, improved General Safety and Performance Requirements, Publicity of data, Clinical Requirements, and scrutiny for advertisement and claims.
Also, national regulations provide specific requirements for the advertisement of devices, prior approval requirements by authorities and transparency regulations for relations with health care professionals (HCPs).
This course gives insight into the laws and regulations governing the marketing and promotion of medical devices in the European Union (EU).
It helps the industry keep their sales reps, marketing professionals, and other employees that have contact with healthcare providers in compliance with these laws and provides guidance on establishing effective marketing and claims compliance processes.
It will also help participants learn about the consequences of violating the advertisement laws.
If you have encountered one of the following questions, this course will give you the correct answers:
- How are EU markets structured, and what levels are responsible for industry marketing and promotion supervision?
- What laws and regulatory documents apply to my marketing and promotion activities?
- How will the competent authorities and notified bodies scrutinise my marketing and promotion materials?
- What is a sound basis for my marketing and promotion claims?
- How do I ensure compliant release processes (SOPs) at corporate and regional levels for multi-country promotion activities?
- Can I promote my professional use of devices in public and for lay persons? When do I need a Drs Check?
- Does a reimbursement status change my promotion capabilities?
- What is the risk of mislabelling or false advertisement?
- What is the responsibility of the manufacturer, authorised representative, and distributor?
- As a sales or marketing professional, what are my responsibilities? What qualifications do I need to promote products in Europe?
- What transparency rule do I need to follow?
