Since MDR came into force, a lot has changed in Europe, especially in regulating previously overlooked areas. For example, Advertising for medical devices must now accurately reflect their intended use as stated in the Technical Documentation. Article 7 of MDR prohibits misleading advertising and off-label promotion, emphasizing the need for accurate and truthful communication across all platforms.
We have seen many cases of people just ignoring this clause.
Manufacturers, how are you ensuring your distributors and importers comply with these stringent requirements? How do you monitor their adherence to the regulation, especially regarding accurate advertising and the prohibition of off-label promotion? Are there specific systems or audits in place to ensure compliance? How do you handle non-compliance when it occurs?
Interested to know your thoughts on this.
