To whom it may concern
Switzerland has so far been able to participate in the EU internal market for medical devices without any restrictions. This was ensured for products that are placed on the market in accordance with two directives (MDD, 93/42 EEC; AIMDD, 90/385 / EEC). They are listed in the agreement between the Swiss Confederation and the European Union on the mutual recognition of conformity assessments (MRA). Since the Institutional Agreement (InstA) between Switzerland and the EU is not approved by Switzerland until May 26th, 2021 and therefore the MRA is not updated, Swiss manufacturers must meet third country requirements to comply with the requirements of the EU medical device regulation (Regulation (EU) 2017/745 - Medical Device Regulation, MDR).
Swiss manufacturers must appoint an authorized representative in the EU or EEA (EC-Rep) and adapt the labeling of their products accordingly. The authorized representative represents the manufacturer in the EU and assumes certain manufacturer responsibilities and risks. The address of the EC-Rep for MIKRONA TECHNOLOGY AG is listed below. Since Germany does not yet accept EUDAMED due to a pending validation, no SRN numbers are currently assigned to companies. Communication with the authorities is currently still running via DIMDI / MPI.
What tasks does the EC-Rep perform?
The EC-Rep becomes the primary contact person for the responsible authorities in the EU or EEA. The minimum obligations of an EC-Rep are laid down in Art. 11 of the MDR. They can be roughly divided into five fields:
– Verification of compliance with registration requirements;
– Update of product registration in the EU;
– Keeping the technical documentation ready;
– Support of the authorities with audits and product tests;
– Reporting of incidents and complaints (so-called Vigilance Report).
What requirements does MIKRONA meet as a manufacturer?
MIKRONA has to provide the EC-Rep with all necessary documents without any restrictions. The labeling of the products must also be adapted, as it must clearly identify the EC-Rep. Furthermore, the name and address as well as the registered SRN (Single Registration Number) of the EC-Rep must be indicated on the declaration of conformity (once it is available). The name and address of the EC-Rep must also be stated on the certificate of conformity. The instructions for use, on the other hand, does not have to identify the EC-Rep.
AND WHAT DOES THAT MEAN FOR YOU?
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