New European regulation on medical devices


As of May 26, 2021, after a one-year postponement due to the Covid-19 pandemic, the new European Medical Device Regulation (EU Reg. 2017/745) becomes effective, which will have a direct impact on all dental laboratory products.

The objectives of the legislation

European legislation aims to: 

  • increase the transparency, quality and safety of medical devices;
  • initiate pre- and post-marketing controls of products;
  • create a unique device identification system that also facilitates the recall of defective products and helps fight against counterfeit devices;
  • hold manufacturers accountable;
  • enhancing the role of the dental technician, giving him or her new tasks to complement what has been done so far.

"The European standard," says the President of Confartigianato Odontotecnici, Ivan Pintus, "strongly reaffirms the centrality of the role of the dental technician, who is required to fulfill a series of duties directly related to the safety of the devices produced. The dental technician is well aware of the importance of compliance with standards at all stages of production and is required to issue a series of information accompanying the prosthesis, a kind of identity card in which are contained all the useful elements to ensure its traceability and safety."

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