Medical Device Regulatory Update Service

In the medical device sector, new legislation, guidelines, and other documents are periodically published that significantly impact the regulatory landscape.

To stay abreast of these developments and be promptly informed of regulatory developments that may impact your business (an activity that has become a legal requirement with the new medical device regulation), Di Renzo Regulatory Affairs provides medical device manufacturers with a regulatory update service. This consists of a periodic report containing the main regulatory developments in the sector.

The types of updates we offer include:

• European and Italian legislation
• Guidelines
• Technical standards published by standardization bodies
• Documents and news from:
  • o institutions (e.g., the Ministry of Health, the European Commission)
  • o trade associations

It is also possible to customize the service based on the product category and the client’s needs, agreeing on which websites to consult, the type of updates to consider, and the frequency with which the summary report is sent.