Bomi Group > News & Stories > The new european regulations will affect your business > Are you a manufacturer?

Are you a manufacturer?


How can we help?

  • We can manage your warehouses and take care of delivering the products to the site of use, ensuring full traceability for all types of device and under any storage conditions (ambient temperature, controlled temperature, etc...).
  • We can provide operational and technical support for the implementation of UDI codes: including directly contacting the competent authorities, registering the products, obtaining UDI codes, filling in the EUDAMED database and managing future updates.
  • We handle the re-packaging process, putting new labels on outer packaging if necessary.
  • We assemble semi-finished products outside the European Community: localisation, implementation of UDI codes and/or producing local labels.

The general requirements for manufacturers are provided in a long and complex article of the new European Regulation and will include:

  1. Responsibilities concerning the safety and efficacy of the device and its compliance with current and future binding requirements
  2. Preparation of a technical file that includes management of the risks associated with their use
  3. Putting procedures and processes in place to ensure that mass production continues to comply with the provisions of the regulation
  4. Post-market data monitoring
  5. Reporting of incidents to the authorities
  6. Liability in case of damage to patients, users or third parties caused by the device.