|The EU’s Medical Device Directive (MDR) will have a major impact on the dental industry, on dentists and of course on patients. According to a confidential survey conducted for the BDIZ EDI at the end of 2019 by the law firm of Ratajczak & Partner, more than half of the participating dental companies plan to make changes to their product range. Almost half of them plan to take products off the market. Although the survey was carried out before the EU Commission extended the transitional period by one year on account of the coronavirus pandemic, this will not affect the prevailing pessimism when it comes to the MDR.|
|The reasons given by the participants included: high expenses associated with the clinical evaluation and clinical trials, administration, (re-)certification, plus special efforts for product-specific requirements.
80 % of respondents expect the prices for existing and new products to increase, by an expected amount of 22 per cent.
It is not yet known to what extent this will affect implants in general.
|Ratajczak & Partner||EDI Journal 1/2020 (only for members)
german version available
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