ENGLISH 26 also be made by the CH-Rep, as this kind of data is no longer exchanged with European databases. But there is good news as well: Apart from the registration obligations and the appointment of a CH-Rep, no other obligations apply to European manufacturers. Switzerland has adopted the regulatory requirements enshrined in the MDR and device certificates are recognised as issued. This applies equally to provisions concerning labelling and the UDI. Notified Bodies are accepted in Switzerland as well. Given that this is essentially tantamount to recognition, it is reasonable to expect that there may still be changes in this regard going forward. It appears probable that Switzerland merely wishes to keep its options open to initiate its own regulations. At present, it remains unclear whether the EU and Switzerland will re-converge in this area in future. Head office of senetics healthcare group GmbH & Co. KG located in Ansbach
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