Medical Devices Legislation

EU Legislation

On 5 April 2017 the European Parliament and council on medical devices published Regulation (EU) 2017/745 (MDR) concerning the clinical investigation and sale of medical devices for human use. 
This regulation was set as an amendment to Directive 2001/83/EEC, regulation (EC) no 178/2002 and regulation (EC) no 1223/2009 and repealing council directives 90/385/EEC and 93/42/EEC.
Link to Regulation (EU) 2017/745 (MDR)

EU Regulation 2017/746 (IVDR) on in vitro diagnostic medical devices was also published on the 5 April 2017, repealing Directive 98/79/EC and Commission Decision 2010/227/EU.
Regulation 2017/746 contains the regulations that must be followed when in vitro medical devices are put on the market and placed into service.
Link to Regulation (EU) 2017/746 (IVDR)

 

Maltese Legislation


Medical Devices And In-Vitro Diagnostic Medical Devices Provision On The Maltese Market Regulations S.L.458.59
Testing of COVID-19 Regulations S.L.458.61


Legal Notices


LN 321 of 2020 Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations
LN 357 of 2021 Testing of COVID-19 Regulations, 2021
LN 118 of 2022 Testing of COVID-19 (Amendment) Regualtions, 2022