The European Council has released the final texts of the Medical Device Regulations (MDR) and In Vitro Diagnostics Regulations (IVDR). The Council is scheduled to vote on the texts on 7th March and the European Parliament is expected to vote on 20th March. The MDR and IVDR are likely to be published in the Official Journal at the end of April/beginning of May. There will be a transition period which will begin once the texts are published and companies will have 3 years to comply with the MDR and 5 to comply to the IVDR. It is important that MedTech companies begin to consider their transition plans as there is no grandfathering under the new legislation.
Along with the final texts, the European Council also published two Draft Statements of the Council’s Reasons which include some useful background.
To read the Medical Device Regulations, please click here.
To read the In Vitro Diagnostics Regulations, please click here.
To read the draft statement of the council’s reasons behind the changes to the MDR, please click here.
To read the draft statement of the Council’s reasons behind the changes to the IVDR, please click here.