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