News New medtech regulations

Medical Device Coordination Group clarifies device and UDI registration timelines under MDR and IVDR

Posted on 02.05.2019

On 15 April 2019, the Medical Device Coordination Group (MDCG) released two new documents
MDCG 2019-4 Timelines for registration of device data elements in EUDAMED
MDCG 2019-5 Registration of legacy devices in EUDAMED

The MDCG 2019-4 document clarifies the inconsistencies of the timelines in the legal text and defines that devices (that are place on the market after Date of Application of the Regulations regardless if covered by Directive or Regulation certificate) should be registered in Eudamed 18 months after the date of application – until 26 November 2021 for MDs and 26 November 2023 for IVDs. This 18-month registration timeline applies if the new database is fully functional by 25 March 2020. If Eudamed is not fully functional on time, then the registration deadline is 24 months after the date of publication of the OJEU notice about Eudamed functionality. However, devices might need to be registered sooner (earlier than 18/24 months after Date of Application) i.e. registration is obligatory in case of serious incident and field safety corrective action reporting.

The MDCG 2019-5 document clarifies that devices with valid Directive certificate which will be placed on the market after Date of Application are required to be registered in Eudamed (this is applicable to both medical devices after the 26 May 2020 and in vitro diagnostic medical devices after 26 May 2022).

MedTech Europe continues seeking clarification on the practical details of how to comply with the content of the referenced MDCG documents. Our members welcome the clarity and certainty that is brought by these MDCG documents which has a close link to the implementation plan of the manufacturers to be able to comply with the rules on time.