Pre-Clinical Requirements for Drug-Eluting Stents for CE Certification

Abstract

Abstract: Drug Eluting Stents (DES) are small, expandable tubes that are implanted into a diseased, blocked peripheral or coronary artery through angioplasty to widen and increase the blood flow by slowly releasing the drug from device. They are covered in a medication that stops scar tissue from expanding upon that artery. In medical practice DES are frequently used for vascular disorders, exhibiting adequate potency and suitability within the acceptable range. Medical device regulations in European Union (EU) are covered by Directives 93/42/EEC, 98/79/EEC and 90/385/EEC which were recently replaced by new regulations (EU) 2017/745 on medical devices and (EU) 2017/746 on In vitro diagnostic medical devices. Across all the EU legislation, “CE Mark” or “Certificate of Compliance” has become a recognised term. The Competent authority’s (CA) certifies that a product conforms to required standards of EU, then the manufacturer display the “CE mark” on the label. The DrugDevice combination products like DES are included in Class-III high risk active implantable medical devices. The pre-clinical investigations of drug eluting stents often follow International Organization for Standardization (ISO) requirements, these vascular stents are covered under ISO 25539-2: 2020 - Cardiovascular Implants - Endovascular Devices, ISO 10993:2018- Biological Evaluation of Medical Devices and ISO 10555-1: 2013 – Intravascular catheters, sterile and single use medical devices.