The Romanian implementation laws of the MDR (Emergency Ordinance no. 46 of 9 June 2021) and of IVDR (Emergency Ordinance no 137 of 12 October…
MDR and IVDR national implementation: Slovakia
The Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostics Devices Regulation 2017/746 (IVDR) have been implemented through Act 362/2011 in Slovakia. In this post, we…
MDR National implementation: Latvia
Latvia has implemented the Medical Devices Regulation 2017/745 (MDR) through its Medical Device Rule No 461 and the Procedures for conducting clinical investigations on medical devices for human…
MDR national implementation: Spain
The Spanish Agency on medical devices (AEMPS) published on March 21, 2023, its national law implementing the Medical Devices Regulation (MDR). This piece of legislation covers devices…
National implementation law: Turkey
The Turkish Medicines and Medical Devices Agency released its national legislation on medical devices in June 2021. In this sense, as per the Customs Union between…
MDR & IVDR national implementation: Malta
The Medicines Act 2020 “Medical Devices and In-Vitro diagnostic Medical Devices Provision on the Maltese Market Regulations” implements the EU Regulations on medical devices and…
MDR & IVDR national implementation: Croatia
Croatian national laws implementing the Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostics Devices Regulation (IVDR) 2017/746 are mainly the Act on the…
MDR & IVDR national implementation: Austria
The Austrian Medical Device Act 2021 implements the EU Regulations on medical devices and in vitro diagnostic medical devices in Austria. The Austrian Federal Office…
MDR & IVDR national implementation: Italy
In August 2022, Italy published the national law implementing the EU Regulations on medical devices and IVD medical devices. Since September 28, 2022, Legislative Decrees…
Upcoming MDR national implementation laws: Portugal
The applicable national implementation in Portugal will be stated under the Decree-Law ensuring the implementation of MDR 2017/745, a decree on MDR clinical investigations and IVDR performance…