Implementation of the new In Vitro Diagnostics Regulation

Implementation of the new In Vitro Diagnostics Regulation

The application date of Regulation (EU) 2017/746 (IVDR) is set for May 2022. The IVDR brings major changes for laboratories, health professionals, industry and patients. However, many elements still have to be put in place to ensure a smooth transition.

The diagnostic sector is concerned that all necessary guidance will not be available on time, particularly regarding the conditions for Laboratory Developed Tests (LDTs). Health institutions depend heavily on LDTs where no appropriate CE-marked tests are available. For example, the rapid development and implementation of LDTs has played a major role in fighting the COVID-19 pandemic.

On 24 September 2020, the former Belgian Member of the European Parliament (MEP), Petra De Sutter, filed a written parliamentary question to the European Commission. She asked three pointed questions. The first one “how will the Commission accelerate the IVDR implementation process and ensure all necessary elements (including essential guidance) are available to stakeholders well ahead of the application date?”, which she followed with “when will the medical device coordination group’s IVD WG taskforce, which will draft the Guidance on Conditions for In-House Devices, be set up and how will the Commission ensure that the input of the diagnostic sector is considered at an early stage?”

Lastly, former the Belgian MEP enquired “which specific issues will be addressed in this guidance, and how will the Commission ensure that all stakeholders’ questions are answered?”

On 27 November, Health and Food Safety Commissioner Stella Kyriakides responded on behalf of the European Commission. In her answer, Commissioner Kyriakides said, “the Commission is working on the implementation of the In Vitro Diagnostics Regulation (IVDR) in the context of the Medical Device Coordination Group (MDCG) of national competent authorities and its sub-groups”. She further explained that “In the interest of patient safety, the Commission together with the MDCG has invested resources into urgent COVID-19 issues in the diagnostics sector alongside IVDR work” and “despite this, the Commission has continued intensive work on IVDR implementation, preparing implementing legislation and coordinating production of guidance”.

Commissioner Kyriakides reported that “the Commission has drawn the attention of the MDCG to key priorities and called on the authorities to provide the necessary support” and “these include vital infrastructure to enable market access of devices as well as guidance that is not legally mandatory but would facilitate the preparation of stakeholders”.

Health and Food Safety Commissioner further clarified that “the Commission continuously involves stakeholders to take their needs and views into account” and “the Commission and many national competent authorities recognise the importance of the topic of the laboratory-developed tests, also known as in-house devices”. She added “the setting up of a task force on the topic of laboratory-developed tests is currently discussed as one of several priorities in the context of IVDR implementation”.

Commissioner Kyriakides highlighted that “the involvement of stakeholders in the diagnostics sector is an essential part of guidance development and will be ensured through consultation of the European associations acting as observers in the relevant MDCG sub-groups”. Finally, she declared that “the specific issues to be addressed will be determined jointly by the members of the task force with input from the relevant stakeholders” and “appropriate coverage of issues will be ensured through stakeholder consultation during guidance development”.

Photo Credit : https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2019/05/what-are-in-vitro-diagnostic-tests-and-how-are-they-regulated

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