European Commission updates on MDR, IVDR implementation timeline

Regulatory NewsRegulatory News | 05 June 2020 |  By 

The European Commission this week updated its “rolling plan” for adopting implementing acts and other measures ahead of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
The update follows the move to delay the implementation of MDR by one year due to the coronavirus disease (COVID-19) pandemic and the decision to delay Eudamed’s rollout by two years last December. (RELATED: MDR delay official as industry calls to push back IVDR, Regulatory Focus 24 April 2020; Eudamed’s 2-year delay: CAMD executive group calls for interim solutions, Regulatory Focus 2 December 2019).
Implementing acts and other activities
The rolling plan lists several upcoming implementing acts concerning the reprocessing of single-use devices; specifications for devices without a medical purpose; the designation of expert laboratories; designations and rules pertaining to EU reference laboratories for in vitro diagnostics (IVDs); Eudamed support and maintenance; and common specifications for high risk (Class D) diagnostics.
The Commission says its implanting act establishing common specifications for reprocessing single-use devices is “undergoing formal adoption procedure,” and is anticipated in Q3 2020. The specifications will cover risk management, validation, product release and performance testing, quality management system, incident reporting and traceability.
The commission also says it is in the planning stages of developing common specifications for groups of devices listed in Annex XVI of the MDR, which addresses products without a medical purpose. “Application of MDR to Annex XVI products depends on the adoption of [common specifications],” the Commission writes. The common specifications are expected to be adopted in Q4 2020.
Implementing acts on the designation of expert laboratories under MDR Article 106(7) and establishing common specifications for Class D IVDs are expected in Q3 2020.
The rolling plan lists three implementing acts related to EU reference laboratories for IVDs slated for adoption. Rules pertaining to the tasks and compliance criteria for EU reference laboratories, as well as rules for fees for advice and testing activities performed by EU reference laboratories, are expected in Q3 2020. An implementing act on the designation of EU reference laboratories is set for adoption in Q1 2021.
 In Q4 2020, the Commission says it will adopt an implementing act providing “detailed arrangements necessary for the setting up and maintenance of Eudamed.”
The rolling plan notes that Eudamed “may go-live from the moment a notice is published in the Official Journal of the European Union” following a positive independent audit. That notice is expected to be published in 2022.
The plan adds that the six Eudamed modules will be made available “as soon as each module becomes operational,” as previously indicated by the Medical Device Coordination Group. (RELATED: EC sets timeline for rolling out Eudamed modules, Regulatory Focus 14 May 2020).
Additionally, the plan indicates that a helpdesk for Eudamed support will go live in accordance with good IT practice prior to Eudamed’s go-live date.


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