The Med­ical Device Coor­di­na­tion Group (MDCG) recent­ly pub­lished MDCG 2024-1, Guid­ance on the vig­i­lance sys­tem for CE-marked devices, and sub-doc­u­ments MDCG 2024-1-1 to MDCG 2024-1-4. The doc­u­ments pro­vide advice aim­ing to har­mo­nize vig­i­lance report­ing prac­tice for cer­tain med­ical device types. This is gen­er­al­ly referred to as Device Spe­cif­ic Vig­i­lance Guid­ance (DSVG). 

The MDCG doc­u­ments super­sede the pre­vi­ous MEDDEV DSVG papers. Spe­cif­ic guid­ance is avail­able for car­diac abla­tion, coro­nary stents, car­diac implantable elec­tron­ic devices and breast implants. 

Man­u­fac­tur­ers and eco­nom­ic oper­a­tors engaged with the cor­re­spond­ing device types are high­ly rec­om­mend­ed to con­sid­er the doc­u­ments. You can down­load them here.

Please let us know should you wish mdi Europa to send the cor­re­spond­ing doc­u­ments to you.

Source: MDCG

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website