(EU) 2017/745 – CE Certification for Medical Devices

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.

  • Significant innovations in MDR (EU) 2017/745 include:
  • Specification of the requirements for the creation and maintenance of the technical documentation for the medical devices,
  • Tightening of the requirements for clinical evaluation,
  • Introduction of a new group of reusable surgical instruments, which are intended for reprocessing,Introduction of an additional control
  • procedure for high-risk medical devices by a panel of experts (so-called Scrutiny procedure),
  • Tightening of the provisions on post-market surveillance of medical devices and the vigilance system,
  • Regulation of the reprocessing of single-use products including the prohibition of the reprocessing of certain single-use products,Improving the
  • 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,
  • Extension of transparency through the European database (EUDAMED), some of which is publicly accessible,
    New classification rules for software, products with nanomaterials and material medical products, among others

“CE mark for medical devices MDR – As of May 26, 2020, the Medical Device Regulation MDR (EU 2017/745) will replace the previously applicable Medical Device Directive MDD (93/42 / EEC).”

“CE mark for medical devices MDR – As of May 26, 2020, the Medical Device Regulation MDR (EU 2017/745) will replace the previously applicable Medical Device Directive MDD (93/42 / EEC).”

(EU) 2017/745 – CE Certification for Medical Devices

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.

  • Significant innovations in MDR (EU) 2017/745 include:
  • Specification of the requirements for the creation and maintenance of the technical documentation for the medical devices,
  • Tightening of the requirements for clinical evaluation,
  • Introduction of a new group of reusable surgical instruments, which are intended for reprocessing,Introduction of an additional control
  • procedure for high-risk medical devices by a panel of experts (so-called Scrutiny procedure),
  • Tightening of the provisions on post-market surveillance of medical devices and the vigilance system,
  • Regulation of the reprocessing of single-use products including the prohibition of the reprocessing of certain single-use products,Improving the
  • 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,
  • Extension of transparency through the European database (EUDAMED), some of which is publicly accessible,
    New classification rules for software, products with nanomaterials and material medical products, among others