Nov 16, 2021

Regulators in Europe have updated their implementation plan for sweeping new in-vitro diagnostic (IVD) medical device regulations taking effect in 2022.

The updated joint implementation plan for the In-vitro Diagnostic Medical Devices Regulation (IVDR), developed by the European Commission as well as European Union member states, prioritizes essential as well as high-priority actions to be undertaken ahead of the IVDR’s May 26, 2022 date of application.

Essential actions for IVDR implementation

Top-priority efforts targeted by European Commissioners within the next six to seven months are grouped together as “essential actions” under three key topics in the joint implementation plan.

The first topic, Contingency planning and monitoring, includes the following essential actions:

  • Establishing a forum for EU member states to communicate risks and critical issues regarding IVDR implementation and ensuring adequate product availability
  • Undertaking market monitoring to evaluate preparedness of stakeholders and protect against IVD device shortages
  • Analyzing the IVDR in the context of hypothetical scenarios of emergency responses to public health crises

Second, European Commissioners have prioritized concerns regarding availability of Notified Bodies:

  • Identifying national experts within EU member states to oversee joint assessments of Notified Bodies
  • Considering effective ways for Notified Bodies can perform conformity assessments during the COVID-19 public health emergency
  • Discussing how to increase Notified Body capacity to meet increased demands for CE Mark certification under the IVDR

Third, essential actions to designate EU reference laboratories include:

  • Opening discussions with member states regarding practical aspects of establishing EU reference laboratories
  • Establishing and adopting implementing acts covering tasks, criteria and fees related to EU reference laboratories
  • Surveying stakeholders on needed capacity of EU reference laboratories
  • Issuing a call for application to EU member states as well as the Joint Research Centre
  • Evaluating applications and designating qualifying applicants as EU reference laboratories
  • Considering whether an EU contribution scheme for tasks not covered by established fees

High-priority actions to support IVDR implementation

European regulators describe high-priority actions as “not essential to allow manufacturers to place devices on the market, but which would greatly facilitate the work of the involved actors.” These actions pertain to:

  • Common specifications
  • Guidance for Notified Bodies such as batch testing and Article 110(3) of the IVDR
  • Performance evaluation and expert panels
  • Standards referred to by the IVDR
  • Companion diagnostics and collaboration with appropriate stakeholders such as the European Medicines Agency (EMA)
  • In-house devices

While some of these essential and high-priority actions may seem ambitious given the IVDR’s May 2022 date of application, many of these efforts have been assigned rolling or ongoing timeframes, and many items in the high-priority section have already been completed. Furthermore, a proposed postponement of deadlines for some IVDR components may provide European regulators and stakeholders more time to conduct some of these actions. Emergo by UL consultants will provide updates on these efforts as they are announced.

Additional European IVDR compliance resources:

  • EU IVDR 2017/746 gap assessment and CE Mark transition support
  • EU IVDR training for IVD medical device manufacturers
  • Whitepaper: Human factors engineering under the EU IVDR

Author

  • Stewart Eisenhart

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