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In January 2024, the MDCG published a Joint Implementation Plan, which results from a review by the MDCG, including the relevant sub-groups, with input from stakeholders. It was endorsed in principle in the MDCG meeting on 28 May 2021. In addition to setting the priorities, the Plan will serve as a living document to monitor their implementation. The status and timelines of the items will be updated to reflect the progress of the work.

 

The following is the critical summary of this Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

 

• The document is a joint implementation plan for the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which sets high standards of quality and safety for IVDs and aims to ensure the smooth functioning of the internal market.

• The document identifies two sets of priorities:

• Set A includes essential actions that enable contingency planning and availability of notified bodies, without which devices may not be placed on the market;
• Set B includes high-priority actions that are not essential but would greatly facilitate the work of the actors, such as designation of EU reference laboratories, common specifications, guidance and standards.

• The document provides a timeline and a status for each priority action, as well as the actors involved in their implementation. It also serves as a living document to monitor the progress of the work and to update the priorities as needed.

• The document also outlines the need for a strategic plan for medium- and long-term actions and a more optimal governance function to ensure the most effective implementation of the IVDR in the interest of public health and patient safety.

 

In the opinion of our experts, In vitro Diagnostic Manufacturers should take the following steps:

• Prepare for compliance with the IVDR by revising documentation, updating procedures, and applying for certification by a notified body if needed.

• Monitor the availability of notified bodies and submit applications for conformity assessment as early as possible, considering the transitional provisions and the possibility of certificates with conditions.

• Comply with the post-market surveillance and vigilance requirements of the IVDR, including submitting a summary of safety and performance and the application or notification of performance studies.

• Follow the common specifications for certain class D devices or justify equivalent solutions, and consult the expert panels or EU reference laboratories where applicable.

• Justify the use of in-house devices according to the conditions laid down in the IVDR and the guidance document MDCG 2023-1.

• Prepare to use Eudamed: Eudamed is the European database for medical devices. Once fully functional, manufacturers must register and submit data on their devices to this database.

• Understand the classification rules: The IVDR introduces a new risk-based classification system for IVDs. Manufacturers need to understand these rules to classify their devices correctly.

• Implement a Quality Management System (QMS): The IVDR requires manufacturers to have a QMS. If you don’t already have one, you’ll need to implement it.

• Plan for continuous post-market surveillance: Under the IVDR, manufacturers must continuously monitor the performance of their devices after they are placed on the market. This includes collecting and analysing user feedback, reporting incidents to authorities, and taking necessary corrective actions.

• Engage in proactive market monitoring: Manufacturers should regularly monitor the market to detect possible barriers that could lead to a shortage of devices. This involves gathering comprehensive data on stakeholder preparedness and readiness to adapt to the changing regulatory environment.

 

 

Experts at Med-Di-Dia are here to help you navigate ongoing requirements arising from the EU MDR/ IVDR and other regulations for your Medical Devices, Diagnostics and Digital Health.

 

Our expert services includes:

• Regulatory Roadmaps
• Clinical Evaluation
• Compliance with relevant acts and regulations
• Preparing, Delivering and Maintaining a Quality Management System
• Representation in different markets [EU Authorised Representative, PRRC, UKRP, USAgent etc]
• Ad hoc and Bespoke Regulatory Support

We are here as your Regulatory Risk Partners!

Connect with us to prepare a plan for your organisation by sending an email – mdd@mddltd.com or by filling out this webform - https://mailchi.mp/1ca078737f9c/ivdr

 

Click here to read the original MDCG Document

 

Read about the October 2022 Edition of the plan.