Improved safety remains the key driver for the new legislation. Requirements include:

  • Stricter control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level
  • Reinforcement of the criteria for designation and processes for oversight of Notified Bodies
  • New roles are created:
    – Responsible person in each manufacturer ensuring regulatory compliance
    – Project leader by NB
  • Extended certification scope, such as:
    – Devices without medical purpose (annex XVI of MDR) but   presenting the same characteristics and risk profile as analogous medical devices under the scope of these Regulations
    – Broader IVD range of products
    – Reusable products, etc.
  • New risk classification system for in vitro diagnostic medical devices in line with international guidance
  • Implementation of a European database (EUDAMED) and an improved tracking system with UDI (Unique Device Identifier) that will improve transparency and give access to MD data to competent authorities, users and patients
  • Introduction of an “implant card” containing information about implanted medical devices for a patient
  • Introduction of a coordinated EU-wide procedure for authorization of multi-center clinical investigations, with reinforced clinical evidence requirements
  • Strengthening of post-market surveillance requirements for manufacturers
  • New vigilance rules and market surveillance for manufacturers and Notified Bodies

Your name

Your e-mail

Name receiver

E-mail address receiver

Your message




Sign up