As was the case with the European Union (EU) Medical Device Regulation (MDR), the Medical Device Coordination Group (MDCG) are endorsing a joint implementation plan for the In Vitro Diagnostic Regulation (IVDR) to support the May 2022 implementation of the new legislation.
IVDR implementation has been identified as a challenging task for all stakeholders due to the many fundamental changes it introduces. Key examples include a new device classification system, greater notified body involvement in conformity assessments and the introduction of EU reference laboratories and expert panels. In order for all relevant parties to fulfil their necessary obligations on time, the paper stresses the importance of collaboration and reassessment of priorities. Consequently, the MDCG’s joint implementation plan highlights where the limited resources available should be focussed in the short term to ensure the date of application is not missed.
The bulk of the paper consists of the priority areas and actions that have been identified by the MDCG based on public health objectives, the needs of stakeholders and patient safety. They are split into two categories, Set A – essential actions and Set B – high priority actions.
Set A – Essential actions
- Contingency planning and monitoring – actions to mitigate the risks of device shortages:
- Engage in an MDCG-level forum to communicate on critical issues related to IVDR implementation, on potential risks of shortages and measures taken to ensure availability of safe and critical IVDs
- Perform a market monitoring exercise to obtain as much data as possible on the preparedness of different stakeholders and aiming at detecting possible barriers that could lead to shortage of devices on the market
- Analyse the IVDR in the context of hypothetical scenarios of an urgent response to a health crisis, scenarios to consider and methodology to be defined.
- Availability of notified bodies – actions to prevent notified bodies from being overwhelmed:
- Make available national experts for joint assessment of notified bodies
- Consider how notified bodies can perform conformity assessment activities in COVID-19 circumstances.
- EU reference laboratories – actions to ensure the effective introduction of EU reference laboratories:
- Discussion with Member States on practical aspects related to EU reference laboratories
- Adopt implementing acts on tasks and criteria and on fees to be levied by the EU reference laboratories
- Carry out a survey on needed capacity of EU reference laboratories
- Issue call for application to Member States and the Joint Research Centre
- Assess the applications and designate the EU reference laboratories
- Investigate a Union contribution for tasks that are not covered by fees.
Set B – High priority actions
- Common specifications – actions for the creation and implementation of common technical specifications:
- Propose the sets of CS that will form part of the first adoption round
- Agree on the text to be adopted as part of the first round
- Adopt the first implementing act containing common specifications.
- Guidance for notified bodies – creation of guidance specific to the IVD industry:
- Complete and endorse guidance on notified body designation codes
- Complete and endorse guidance on batch testing for notified bodies.
- Performance evaluation and expert panels – actions to ensure that the more stringent performance evaluation requirements being introduced are clear to manufacturers:
- Complete and endorse guidance on performance evaluation
- Develop and endorse a clarification on what constitutes a “type of device” and on the process to be followed by notified bodies in context of views of the expert panel
- Develop and endorse template for summary of safety and performance.
- Standards – requesting the relevant European standardisation organisations to revise existing standards and develop new ones:
- Adopt the implementing act on the MDR/IVDR standardisation request and accept it
- Adopt the implementing act on the publication in the OJEU of references to harmonised European standards in support of the IVDR requirements.
- Companion diagnostics – guidance on how companion diagnostics (devices essential for the safe and effective use of a corresponding medicinal product) are regulated under the IVDR:
- Regarding the consultation of medicinal product authorities, accompany the work of the EMA and stakeholders, notably on procedural elements.
- In-house devices – clarify the regulation of devices developed and used within the same health institution:
- Develop guidance explaining the provisions on in-house devices.
For more details on the implementation plan, click here.