Establish and maintain a Medical Quality Management System (QMS).How to achieve Europe Medical Device Registration and apply CE mark ? In order to get CE mark, you need to comply with one or more of the following requirements: Safety and reliability requirements the product should meet, which includes items such as biocompatibility, software validation, electrical safety, electromagnetic compatibility (EMC), performance evidence, technical performance evidence, and pre-clinical and clinical evidence.

Quality system Requirements, with which the manufacturer should comply, regarding the development and the manufacturing of the product.The requirements of the CE can be divided into two major categories:

Regarding the In Vitro Diagnostic Regulation 2017/746 the date of entry into force was also and it will become mandatory on. Since the Medical Device Regulation 2017/745 which entered into force on became mandatory and replaced the Medical Device Directive and the Active Implantable Medical Device Directive (those are no longer an option to obtain CE marking). This means that any company, interested in selling a product in one of the European Community countries, must comply with the requirements of the applicable Regulation and must mark its product with the CE symbol according to those requirements. The European Community has formally adopted several Directives (or regulations – see below) that apply to the Europe Medical Devices Registration. Europe Medical Device Registration – Compliance with European Directives (MDD, AIMD, IVDD) or Regulations (MDR, IVDR)

Design dossier definition