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Bumps On The Path To EU Harmonized Standards Path As Stakeholders Demand Speedier Progress

 
• By Amanda Maxwell

The number of standards published so far in the context of the EU’s new medtech regulations is a drop in the ocean compared with the total needed. A recent meeting looked at why this has happened and how headway will now be made.

bumpy road

The process of developing harmonized standards in the context of the EU’s Medical Device and IVD Regulations should be speeded up as much as possible so that their references can be published in the Official Journal of the EU and the sector can use them as evidence of compliance with the new regulations.

There also needs to be “more transparency in terms of standardization items under development and the related timing and priorities.”

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