New EU regulations for medical devices (MDR) and in-vitro medical devices (IVDR) have been introduced. These regulations entered into force on 25 May 2017 across EU Member States. However, most requirements will not fully apply until 26 May 2020 for the MDR, and 26 May 2022 for the IVDR.
New EU regulations for medical devices (MDR) and in-vitro medical devices (IVDR) have been introduced. These regulations entered into force on 25 May 2017 across EU Member States. However, most requirements will not fully apply until 26 May 2020 for the MDR, and 26 May 2022 for the IVDR.
Links
[1] https://www.hta.gov.uk/policies/clarification-scope-medical-devices-regulation-tissues-and-cells-products
[2] https://www.hta.gov.uk/policies/clarification-scope-medical-devices-regulation-tissues-and-cells-products-0