Swedish MDR/IVDR implementation law: Fees, penalties and other provisions

Sweden published its implementation law of the Medical Devices Regulation 2017/745, also applying to the In Vitro Devices Regulation 2017/746. This Act establishes several provisions under these two regulations and provides additional requirements by Swedish authorities. Namely, the main points of this law are the following:

Applicable fees and penalties

The Swedish law establishes multiple fees to be paid for those who apply to conduct or notify a clinical trial/performance study or report substantial amendments (Chapter 4 Section 1). Moreover, a fee is also applicable for those who apply for authorization to place in the . . .


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