Due to the corona pandemic and the resulting urgent work for the medical device industry, the already very tight transitional period of three years for classical medical devices became an issue that could no longer be implemented. The European Parliament and the Council therefore decided on 23 April 2020 to extend the transitional period by one year. This gives more room for manoeuvre, especially for class I medical devices and for class I devices that are classified in a higher class according to MDR and were not yet on the market as per 26 May 2020. For class I, which according to MDR are upgraded to a higher class and were already on the market, extended transitional periods already applied until now (due to the impossibility of obtaining the certifications in time). This will remain unchanged.
Dr. Katharina Oehler
Scientific and Managing Director
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