The EU Regulation on Medical Devices 2017/745 (MDR) changes significantly the landscape for the medical device industry. The new Regulation introduce novel requirements in key areas such as stronger Notified Body (NB) and Competent Authority (CA) oversight, improved General Safety and Performance Requirements, Publicity of data, Clinical Requirements as well as scrutiny for advertisement and labelling. Also national regulations provide for specific requirements as for the advertisement of devices, prior approval requirements by authorities and transparency regulations for relations with health care professionals (HCPs).
The course will give insight on the laws and regulations governing the marketing and promotion of medical devices in the European Union (EU). It helps industry to keep their sales reps, marketing professionals, and other employees that have contact with healthcare providers in compliance with these laws and provides guidance how to establish effective marketing and claims compliance processes. It will also help participants to learn about the consequences to violating the advertisement laws.If you have encountered one of the following questions, this course will be giving you the right answers:
- How is the EU market structured and what levels are responsible for supervision of industry marketing and promotion?
- What laws and regulatory documents are applicable to my marketing and promotion activities?
- In what way will my marketing and promotion materials be scrutinized by the competent authorities and notified bodies?
- What is a sound basis for my marketing and promotion claims?
- How do I insure compliant release processes (SOPs) at corporate and regional level for multi country promotion activities?
- Can I promote my professional use device 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, authorized representative, distributor?
- As a sales or marketing professional, what are my responsibilities? What qualification do I need to promote products in Europe?
- What transparency rule do I need to follow?