Medical Devices Legislation

EU Legislation

On the 5 of 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 5th of 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

The Maltese legislation contains three subsidiary legislations:

Active Implantable Medical Devices Regulations S.L.427.10

In Vitro Diagnostic Medical Devices Regulations S.L.427.16

Medical Devices Regulations S.L.427.44

 

Legal Notices 

LN 318 of 2020 In Vitro Diagnostic Medical Devices (Amendment) Regulations

LN 321 of 2020 Medical Devices and In-Vitro Diagnostic Medical Devices Provision on the Maltese Market Regulations

LN 49 of 2021  Delivery and Testing of COVID-19 using Point-of-Care Rapid Testing, Regulations

LN 131 of 2021  Delivery and Testing of COVID-19 using Point-of-Care Rapid Testing (Amendment), Regulations