Abstracts by keywords: EU regulation of medical devices; patient safety; European Union; hip prosthesis; breast implants; Cardioverter Defibrillator (ICD) Leads; intracranial stenting
What can be demanded when it comes to market access for high-risk medical products?
The scandal surrounding breast implants that ruptured far too easily and were also filled with industrial silicone drew attention in Europe to the safety of high-risk medical products, so that the subsequent scandals were also taken up in public discourse. Now it remains to be seen whether Europe can defend itself against lobby pressure and actually improve safety for patients with the new medical device regulation.