Not Over Yet The updated New Approach certainly will be considered by more Competent Authorities

Not Over Yet

The updated New Approach certainly will be considered by more Competent Authorities in the recast of the MDD, AIMDD and IVDD. Hence, it only will be a matter of time before it is apparent whether the Polish Act serves as a blueprint for the European Union. Whether any added responsibilities imposed upon importers and distributors across multiple member states would impact the overall business climate for medical devices in the European Union warrants careful consideration ahead of the recast.