The European Commission has set out its latest timeline for the completion of implementing acts and other activities critical to the incoming Medical Device and In Vitro Diagnostic Regulations. 

The COVID-19 crisis led the EU at the 11th hour to postpone MDR, now slated to go into effect next May. The IVDR has not been postponed from its go-live date of May 2022, although some in the industry is pushed on that front.

With MDR and IVDR necessitating the creation of a multitude of supporting documents, the Commission has maintained a rolling plan detailing its targets for completing key projects and its progress to date. The latest update, published Wednesday, lays out what the medtech industry can expect over the next two years or so. 

June 2020

• By June 17, the European Committee for Standardization and the European Committee for Electrotechnical Standardization are due to rule on an implementing decision adopted by the Commission last month. The ruling is part of the process of aligning existing standards to the new regulatory framework. 

Q3 2020

• A Commission implementing act covering requirements for the reprocessing of single-use medical devices is going through the formal adoption procedure ahead of a final decision in the third quarter. The topic has been a source of contention between the Commission and parts of the medtech industry.  

• A Commission implementing act on the designation of expert laboratories is due in the third quarter, but is yet to get beyond the planning stage. The Commission can designate expert laboratories to support its need for expertise in relation to the implementation of MDR.

• Implementing acts on common specifications for IVD Class D and rules covering European Union reference laboratories and their fees are also still in the planning stage. Both acts are due in the third quarter.

Q4 2020

• The Commission is due to establish common specifications for products without a medical purpose in the fourth quarter. The implementing act is still at the planning stage.

• A Commission implementing act regarding setup and maintenance of the delayed medtech database ​Eudamed is also scheduled for the fourth quarter. The act will mainly cover support, change management and maintenance rules. Currently, the Commission is still planning the act.

Q1 2021

• An implementing act supporting the creation of EU reference laboratories active in the IVD space is penciled in for the first quarter of 2021. Under IVDR, the designation of reference laboratories cannot happen before Nov. 25. 

2022

• The Commission expects an independent audit of Eudamed ​to happen in 2022. If the audit persuades the Medical Device Coordination Group that the database meets the specifications, EU authorities will publish a notice to confirm it is ready to use. The Commission expects the database to go live in 2022. 

• Between now and then, the Commission plans to make the six Eudamed ​modules available on a rolling basis as they become operational. The Commission committed to the staggered introduction of the modules in its updated implementation plan. 

• A helpdesk to support the set up and maintenance of Eudamed ​is also set to come online sometime before the database goes live in 2022.