Soon we will be moving into the second half of the transition period for "flipping" legacy devices into MDR mode. Unfortunately, as practice shows, the transition to MDR is often as smooth as sandpaper. The purpose of this article is to focus on one area where things are getting a bit rough, namely the possibility of translations of IFU's by importers and distributors.
In order to be supplied in the Czech Republic, the device must be equipped with instructions in Czech. However, a situation may arise where a device arrives to the distributor or importer lacking Czech instructions. This problem affects not only the so-called parallel traders, but often also the official supply network, as the Czech Republic is a small and not very lucrative market for foreign manufacturers.
Until recently, the issue of translations was in a kind of grey area. There was no legal regulation, but the Court of Justice of the EU ruled that it is possible to translate instructions if necessary and SÚKL accepted it. The new rules for translation of instructions can be found in Art. 16 MDR. In general, the effort to legislate is welcome, but there is a catch - only an entity that has been certified by a quality management system by a notified body appointed for the type of device can translate instructions for products placed on the market under the MDR.
We have been monitoring the situation regarding the possibility of certification under Article 16 MDR for a long time. At first, notified bodies were turning us away, saying that they were waiting for guidance from the Commission on how to certify. With the publication of the MDCG 2021-23 in August 2021, a spark of hope has been ignited that the door for this certification has finally opened. In the summer of 2022, we reached out (again) to all of the notified bodies designated under the MDR, but have yet to receive a single positive response. They simply do not have the capacity for these activities.
From a situation where the translation of the guidelines was allowed, but there was no legislative regulation, we have therefore reached a situation where the rules exist, but it is not possible to actually implement them. While the Commission is pressing manufacturers to ensure that the MDR requirements are met in time, one has to wonder whether it is (only) the manufacturers who are somewhat asleep. The situation regarding the (in)possibility of certification under Article 16 of the MDR indicates that the Commission should first sweep its own doorstep.
Author: Veronika Moravová