Dáil Éireann Debate, Wednesday - 1 February 2023
197. Deputy John Paul Phelan asked the Minister for Health his views on the impact of the European Commission's proposed timeline extension for the EU Medical Devices Regulation for notified bodies in Ireland. [5065/23]
View answer258. Deputy John Paul Phelan asked the Minister for Health the number of meetings he has held with his European counterparts to discuss the EU Medical Devices Regulation and its impact on the certification of medical devices; and if he will make a statement on the matter. [5067/23]
View answerI propose to take Questions Nos. 197 and 258 together.
Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (‘IVDR’) have been fully applicable as of 26 May 2021 and 26 May 2022, respectively.
The overarching objectives of these new regulations are to significantly strengthen the regulatory system for medical devices and provide for a framework that is robust and consistent and serves to enhance public health across the EU by ensuring that medical devices are safe, perform as intended and afford benefits to patients and healthcare systems whilst also supporting innovation.
Implementation of the new regulations has not been without challenge and one of the core and longstanding challenges relates to the capacity of the system in certifying devices under the new framework, which has been compounded by the Covid-19 pandemic. I am aware of the consequences of notified bodies not being in a position to certify devices at sufficient scale, thus causing a risk of significant disruption in the supply of medical devices to patients. Over the last number of months in particular, Ireland has dedicated significant time and commitment together with other stakeholders at a national and European level, in identifying solutions to this imminent challenge.
Significant work, led by the EU Commission has taken place over the past year in particular in responding to this challenge including gathering data from stakeholders on the market status of certification, the continued monitoring of same, dedicated engagement with notified bodies at an EU level to gather their feedback and insight on this matter and potential supports required, publication of the Medical Devices Coordination Group (MDCG) action plan via MDCG position paper 2022-14 which acknowledges that the data gathered to date indicates that there are multiple causes which require a mix of solutions and sets out a series of proposed action to enhance notified body capacity, access to notified bodies and manufacturers’ preparedness to facilitate transition to the MDR and IVDR and to avoid shortage of medical devices. The MDCG has committed to implementing and supporting implementation of these actions in a timely manner, to assess the progress made in response to same, the impact of the actions and an assessment of whether further actions will be needed and work in this regard is underway. The success of these actions will be dependent on full engagement and implementation by all stakeholders and monitoring of their effectiveness by the MDCG will be reliant on stakeholders providing the data necessary for the monitoring of the market. Most recently, and as you refer to Deputy, the EU Commission has proposed a conditional extension of the transition periods of the MDR due to the risk of significant disruption in the supply of medical devices due to the overall capacity of notified bodies remaining limited and with many manufacturers not yet sufficiently prepared to meet the robust requirements of the MDR by the end of the current transition period. To this end, urgent and decisive action was required to prevent a major EU-wide patient safety and public health threat. I therefore welcome the EU Commission's proposed targeted legislative amendment to the MDR, which I believe strikes the best balance between mitigating the impending risk of medical devices shortages while also ensuring the implementation of the new regulatory framework and my officials are working via EU fora to examine this proposal currently with a view to ensuring its speedy adoption in the interest of ensuring that the devices our citizens and health systems rely on, remain available. The proposal will afford more time to notified bodies and manufacturers to transition from the previously applicable rules to the requirements of the MDR, subject to specific conditions.
At a national level, my officials have engaged with notified bodies though engagement at EU fora and with our notified body here in Ireland thought the Department of Enterprise, Trade and Employment and the Health Products Regulatory Authority (HPRA) to gather their views on this matter and supports required.
It is incumbent now on all stakeholders to recognise our respective roles in ensuring the full, timely and effective implementation of these new regulations and to have in place a regulatory system that delivers on its objectives.
With respect to engagement at EU level, Ireland has retained committed and ongoing engagement with the EU Commission and EU member states over the past several years in relation to these regulations. The HPRA are members of the above mentioned MDCG, which was set up under the regulations to support their full implementation. A number of working groups and taskforces under the MDCG are established to facilitate this objective and the MDCG has published a vast amount of guidance to stakeholders to date. Officials in my department also engage with EU partners in ensuring the successful implementation and application of these regulations and my department has committed significant resources to facilitate this work and most recently engage with the EU Commission in considering its recent proposal and working towards the swift adoption of same.
It is important to recall Ireland’s intervention at the EPSCO Health Council meeting in June 2022, at which my colleague Minister Feighan attended and raised concerns regarding implementation of these new regulations. Ireland’s lead member state intervention was well-supported by other member states. It must be noted that considerable work took place since the June 2022 EPSCO at EU level in response to the certificate capacity issue, as referred to above. At the EPSCO Health Council meeting in December last month, I attended and again raised concerns regarding the serious and stubborn shortfall in the number of devices certified to the new framework and called for a proposed targeted legislative amendment to strike the best balance between mitigating the impending supply risk while also ensuring the implementation of the new regulatory framework. Again, this intervention was widely supported by EU Health Ministers. It should be noted that even prior to last year, Ireland has intervened at several EPSCO Health Council meetings on this matter.
I am pleased to say that on 6 January 2023, the EU Commission submitted a proposal to the Council and to the European Parliament for a Regulation amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro d iagnostic medical devices. As mentioned, this targeted amendment is focused on allowing manufacturers and notified bodies additional time to transition from the previously applicable rules to the requirements of the Regulation, subject to specific conditions. Ireland is fully supportive of the amendment and is actively working at EU level to consider this file and work towards its imminent adoption in the interest of patient safety and public health.
Ireland continues to work actively and collaboratively with our EU partners on monitoring this situation. The full and effective implementation of the regulations, whilst ensuring that citizens and healthcare systems continue to have access to the devices they rely is a key priority for my department. It remains imperative that we continue to work collectively across the EU finding and implementing harmonized solutions to these challenges, in order to ensure that the new regulatory system is effective in practice and delivers on all of its objectives.
The full and effective application of these regulations remains a strategic priority for me and my department and I fully recognise the integral role that medical devices play in healthcare delivery and public health and the need to ensure that there is a sustainable, predictable and robust regulatory framework in place to underpin this sector. Ireland continues to work collaboratively with all stakeholders to implement these regulations fully and effectively and address challenges threatening same, ultimately ensuring that the benefits of these regulations are realised in practice.
