The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for medical devices intended to be marketed and used in the EU, has published a joint implementation and preparedness plan for the In Vitro Diagnostic medical devices Regulation 2017/745 (IVDR), which is planned to enter into force later in May 2022.
The present document describes how the aforementioned Regulation should be implemented. It is intended to be used for reference by all the parties involved. The latest version of the document was published by the MDCG in June 2021. The document was developed by the sub-groups of the MDCG in collaboration with stakeholders. The plan should also be used for tracking the actual implementation process. Hence the timelines indicated therein could be subject to changes reasonably necessary to reflect the implementation process.
First, the MDCG mentions that the entirely new regulatory framework was introduced earlier in April 2017. It includes two regulations, namely:
- Regulation (EU) 2017/745 on medical devices (MDR), and
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
The Regulations listed above are intended to replace existing Directives and improve the regulatory framework for medical devices in order to ensure that any and all devices marketed and used in the EU are compliant with the high standards in terms of safety and effectiveness. The new Regulations will strengthen the applicable requirements medical devices should comply with.
Initially, the implementation plan for MDR was developed by the MDCG in March 2020. The same approach is intended to be applied for IVDR. It is stated that the present document constitutes a draft joint implementation plan for the IVDR. The MDCG also mentions that the IVDR provides a longer transitional period which constitutes 5 years. This period will be used to introduce an entirely new medical device classification system, expand the involvement of notified bodies, and create new regulatory structures: the EU reference laboratories and expert panels.
As stated in the document, the actual implementation of the IVDR will require the active involvement of all stakeholders. The main milestones include:
- Designation of new notified bodies entitled to carry out conformity assessment of medical devices falling within the scope of their designation,
- Implementation of the Unique Device Identifier system,
- Further development of the Eudamed – an EU-wide database containing information about any and all medical devices allowed for marketing in the EU,
- Designation of the IVD expert panel and appointment of an expert,
- Development of new specifications and guidance documents.
The new regulatory approach will also require all the parties involved to review existing procedures and take additional measures in order to achieve and sustain compliance with the new requirements. However, despite all the efforts made, the implementation of the in vitro diagnostic medical devices regulation is still a challenging process.
The primary purpose of the present document is to highlight the most important aspects of the IVDR implementation process in order to assist the parties involved in focusing their resources and acting in the most efficient way. It is stated that the priorities set out in this document have been identified based on the objectives of public health, patient safety and transparency, which are key to the new legislation, as well as the most urgent needs for the stakeholders. At the same time, the MDCG acknowledges the significant efforts to be paid to withstand the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus SARS-CoV-2 or the “novel coronavirus”, which makes the implementation process lengthy and complicated.
IVDR Implementation Priorities
According to the document, all priorities could be divided into two groups:
- Set A, which includes actions that are vital for devices to have access to the market (those related to a framework for contingency planning, availability of notified bodies and designation of EU reference laboratories), and
- Set B, which includes legalization and guidance documents that, while not obligatory, would greatly facilitate the work of the actors.
The MDCG emphasizes the importance of finding an optimal balance in the allocation of the resources available. It is important to establish a proper balance between the actions taken to achieve short-term and long-term objectives.
Implementation Priorities in Detail
The document further describes each set of actions to be taken in order to ensure the correct and timely implementation of the in vitro diagnostic medical devices regulation.
As mentioned, the actions included in Set A are necessary to ensure correct operations on the new regulatory framework. In particular, they are related to the most important elements of infrastructure: the EU notified bodies and the EU reference laboratories. This section covers the following spheres:
1. Contingency planning and monitoring. The MDCG will continue playing an important role in the actual implementation of the IVDR. It will be involved, for instance, in analyzing the risks associated with the availability of medical devices, considering the allocation of resources, and other measures. The MDCG will pay special attention to the availability of vitally important medical devices on the market in order to prevent potential shortages that could be caused by changes in regulatory requirements and the failure of the responsible entities to achieve compliance in time. These processes also require an efficient information exchange to be established. Thus, the MDCG intends to:
- Identify the risks related to potential shortages and take all the measures necessary to address them,
- Conduct continuous monitoring in terms of preparedness of the various parties involved in order to identify potential shortages in supply, and
- Determine the approach to be applied in case of emergency, during which special regulatory measures would be required to ensure the uninterrupted availability of vitally important medical devices for healthcare professionals and patients.
2. Availability of notified bodies. The effectiveness of the new regulatory framework mostly relies on the EU notified bodies duly designated to conduct conformity assessment of medical devices within the scope of their designation. The lack of notified bodies designated under the new Regulations could result in their inability to deal with the increasing number of requests from industry representatives. As a consequence, this could lead to shortages in the supply of medical devices. For instance, the MDCG states that according to the information provided by the stakeholders, under Directive 98/79/EC, around 10% of all IVDs placed on the market need notified body involvement, whereas, under the IVDR, this will rise to 80-90%. This partially results from changes in the classification of in vitro diagnostic medical devices to be introduced under the new framework. The actions to be taken in this regard will include:
- Making available national experts for joint assessment of notified bodies (Member States), and
- Considering how notified bodies can perform conformity assessment activities in COVID-19 circumstances.
In summary, the present document describes the particular measures to be taken in order to facilitate and streamline the implementation of the IVDR. The MDCG outlines the actions to be conducted by the parties involved and justifies them from a regulatory standpoint.
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