Your challenge – our solution

The new European Medical Device Regulation (EU) 2017/745 came into force on 25 May 2017. It  replaces the two European Directives 93/42/EWG and 90/385/EWG. With some exceptions, the new regulation must be fully adopted by 26 May 2020.

The major changes are:

  • More precise specifications for planning clinical evaluations
  • Detailed regulation for the approval of clinical investigations
  • Tightening of regulations governing vigilance and market surveillance
  • New classification rules for material-based medical devices, additional rules for products with nanomaterials and software
  • New rules for the reprocessing of single-use devices
  • Introduction of the Unique Device Identification (UDI) system
  • Extension of the European database for medical devices (EUDAMED)
  • Requirement for manufacturers to provide sufficient financial coverage in respect of their potential liability

SCC can help you incorporate this new regulation into your company.

We can also help your R&D department with ISO 13485 procedure definitions and finding suitable funding programmes.

In addition to this, we have in-depth experience in the qualification and validation of your products as well as production and quality control equipment and methods.

Further, SCC offers international approval of medical devices, directly or in cooperation with our international partners.