IQoro meets the new, more rigorous demands for the CE mark

IQoro meets the new, more rigorous demands for the CE mark

A CE Mark is needed in order to introduce a MedTech product into the EU and currently the UK markets. Starting from 26th May 2021 the new MDR regulations 2017/745 will apply. These set higher demands on suppliers, but what will they mean for consumers?

A summary of the new MDR regulations

  • Increased demand for clinical evidence
  • Better protection for consumers
  • More openness in making important product information available
  • Greater demands for post-marketing surveillance and Quality Management System stringency
  • Consistent demands across all EU countries (and, currently at least, in the UK too)

How has MYoroface adapted to these new rules?

Ylvali Gerling, CEO at MYoroface, explains,

–The new rules come into force on May 26th; from today all products intended for medical use must meet these new regulations.

–All manufacturers must now meet a much higher set of demands regarding transparency, the contents of the product’s technical documentation and more. As a start, we must inform our customers about the products’ lifecycles, and exactly what they can be used for and how they are to be recycled. For us, the new regulations have included our having to rewrite and reprint all user manuals and product cartons in every language in which we supply. The aim is to give customers all the information about our product that they are now entitled to under the new rules.

–Manufacturers must include a clinical evaluation as part of their technical file documentation. This means that so-called clinical evidence or clinical evaluation must be present and documented before a product can be launched on the market. The opportunity to merely compare with similar existing products is now very limited under the new regulations. This will usually mean that a manufacturer must complete the technical file with its own clinical data.

–We think that it is positive that the rules have been tightened and that products intended for medical use will need to meet these new regulations including documenting clinical evidence. Our customers can feel reassured that IQoro meets all the new regulations, Ylvali concludes.