(EU) 2017\/745 – CE Certification for Medical Devices<\/h3>\n
After more than four years of negotiations at European level, Regulation (EU) 2017\/745 on medical devices came into force on May 25, 2017. With a few exceptions, the regulation will apply from May 26, 2020 and will replace the two medical device directives 90\/385 \/ EEC and 93\/42 \/ EEC.<\/p>\n
\n- Significant innovations in MDR (EU) 2017\/745 include:<\/li>\n
- Specification of the requirements for the creation and maintenance of the technical documentation for the medical devices,<\/li>\n
- Tightening of the requirements for clinical evaluation,<\/li>\n
- Introduction of a new group of reusable surgical instruments, which are intended for reprocessing,Introduction of an additional control<\/li>\n
- procedure for high-risk medical devices by a panel of experts (so-called Scrutiny procedure),<\/li>\n
- Tightening of the provisions on post-market surveillance of medical devices and the vigilance system,<\/li>\n
- Regulation of the reprocessing of single-use products including the prohibition of the reprocessing of certain single-use products,Improving the<\/li>\n
- identification and traceability of products by introducing a unique product identification number (UDI),Obligation of the manufacturer to provide coverage in the event of liability,<\/li>\n
- Extension of transparency through the European database (EUDAMED), some of which is publicly accessible,
\nNew classification rules for software, products with nanomaterials and material medical products, among others<\/li>\n<\/ul>\n<\/div><\/div><\/div>