The Medical Device Coordination Group (MDCG) has recently published a joint implementation and preparedness plan for the In Vitro Diagnostic medical devices Regulation 2017/745 (IVDR). It is well known that the IVDR is expected to come into force later in May 2022. As the IVDR implementation sets specific challenges for the stakeholders, the European Commission (EC) and the Member States, the MDCG reviewed the relevant inputs from all the stakeholders and established a joint implementation plan.

The MDCG document highlights the most critical aspects of the IVDR implementation process to assist the parties involved in focusing their resources and acting in the most efficient ways. As per the document, the actual implementation of the IVDR will require the active involvement of all the stakeholders and will include some milestones. Let’s explore what they are.

MDCG’s IVDR Plan Milestones

  • Development of new specifications and guidance documents
  • Designation of new Notified Bodies (NBs) entitled to carry out the conformity assessment of medical devices falling under the scope of their designation
  • Appointment of an expert and designation of the IVD expert panel
  • Implementation of the Unique Device Identifier (UDI) system
  • Further development of the EUDAMED – an EU-wide database containing information about all medical devices allowed for marketing in the EU

IVDR Implementation Priorities

The priorities set out in the MDCG document have been identified based on the objectives of public health, patient safety and transparency, which are key to the new legislation and the most urgent needs of the stakeholders. As per the document, all the priorities could be divided into two (02) groups:

  • Set A:  It includes actions that are vital for devices to have access to the market (those related to a framework for contingency planning, availability of the Notified Bodies and designation of the EU reference laboratories)
  • Set B: It includes legalization and guidance documents that, while not obligatory, would greatly facilitate the work of the actors

Set A: This section describes the actions that enable contingency planning and those on the vital infrastructure of the IVD sector, without which devices may not be placed in the market. They include:

  • Contingency planning and monitoring
  • Availability of Notified Bodies
  • EU reference laboratories

Set B: This section describes the actions that are not essential to allow manufacturers to place devices on the market. They include:

  • Common specifications
  • Guidance for Notified Bodies
  • Performance evaluation and expert panels
  • Standards
  • Companion diagnostics
  • In-house devices

Overall, the MDCG emphasizes the importance of short-term priorities. This should be seen in the context of continuous prioritization by all the parties involved beyond May 26, 2022. To know more about the MDCG’s implementation and preparedness plan, consult Freyr - a proven Regulatory expert. Stay informed. Stay compliant.


Related Posts by Category