What changed

B100123/2024

Non-substantial follow-up to the European Parliament non-legislative resolution on the urgent need to revise the Medical Devices Regulation

EuropeanResolution Parliamenttabled resolutionpursuant onto theRules urgent136(2) needand to(4) reviseof the MedicalEuropean DevicesParliament’s RegulationRules of procedure

(2024/2849(RSP))

Reference number: 2024/2849 (RSP) / RC-B10-0123/2024 / P10_TA(2024)0028

The European Parliament,

Date of adoption of the resolution: 23 October 2024

– having regard to the Treaty on the Functioning of the European Union, and in particular Article 168 thereof,

Competent Parliamentary Committee: N/A

– having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (MDR),

Competence: Commissioner Kyriakides

– having regard to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (IVDR),

The Commission will not be responding formally to the requests addressed in the resolution as they were comprehensively addressed in plenary on 9 October 2024 by Vice-President Jourova on behalf of Commissioner Kyriakides.

– having regard to Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices,

– having regard to Regulation (EU) 2020/561, Regulation (EU) 2022/112, Regulation (EU) 2023/607 and Regulation (EU) 2024/1860 extending the implementation periods of Regulation (EU) 2017/745 and Regulation (EU) 2017/746,

– having regard to Council Regulation (EU) 2022/2372 of 24 October 2022 on a framework of measures for ensuring the supply of crisis-relevant medical countermeasures in the event of a public health emergency at Union level,

– having regard to Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices,

– having regard to Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU,

– having regard to Rule 136(2) of its Rules of Procedure,

A. whereas the MDR and IVDR were adopted to enhance patient safety, improve the quality and effectiveness of medical devices and diagnostics and ensure better oversight throughout their life cycles, while setting high quality and safety standards for medical devices to address common safety concerns and taking a high level of protection of health as a foundational principle;

B. whereas the MDR and IVDR introduced more robust requirements for clinical evaluations, post-market surveillance and vigilance reporting, promoting transparency in the approval and monitoring processes;

C. whereas the MDR and IVDR address issues related to the previous directives, such as insufficient oversight and inconsistencies in how devices were evaluated and monitored; whereas the regulations aimed to create a more uniform and reliable market;

D. whereas medical devices and in vitro diagnostic medical devices have a fundamental role in saving lives by providing innovative healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;

E. whereas lack of availability of necessary devices can have serious consequences for patients and their safety, and bring about a higher risk of morbidity;

F. whereas disparities in access to various medical devices still exist across the Member States, affecting patient care;

G. whereas some notified bodies, especially ones dealing with the IVDR, have struggled to meet the increased demand for certification owing to a lack of capacity and resources, which has resulted in significant delays in getting devices to the EU market, and at times creating bottlenecks;

H. whereas due to a lack of harmonised procedures across notified bodies in the EU, among other things, manufacturers can in some instances face unpredictable timelines for certification and market access, which creates unpredictability;

I. whereas the transitional periods for the implementation of the MDR and IVDR have been extended on numerous occasions to address issues including the capacity of notified bodies and to allow industry more time to adapt to new rules in order to prevent devices being taken off the EU market;

J. whereas since the adoption of the MDR and IVDR, the Commission has also introduced new provisions regarding the European Database on Medical Devices (EUDAMED) and a notification system for market interruptions or supply discontinuation;

K. whereas in addition to extensions of the deadlines, the Commission has also taken a number of non-legislative actions to address implementation issues, including providing targeted support, particularly to small and medium-sized enterprises (SMEs), but also for the coordination of notified bodies, waivers on scientific advice, and tailored solutions for orphan devices, among others;

L. whereas the MDR and IVDR frameworks should better support start-ups and SMEs in bringing new and innovative products to the EU market;

M. whereas specific challenges exist for certain categories of devices including orphan devices, paediatric devices and devices intended for rare conditions for which targeted solutions are needed;

N. whereas despite the MDR and IVDR, there remains a lack of coordination and harmonisation of assessment procedures across notified bodies in the EU, which can create unnecessary duplication of work and delays;

1. Remains strongly committed to the core objective of the review of the MDR and IVDR to ensure patient safety above all, through higher quality and safety standards of medical and in vitro diagnostic medical devices;

2. Regrets the implementation of the MDR and IVDR frameworks thus far and the repeated need for urgent procedures to extend transitional deadlines; considers that an enduring solution is needed to operationalise and achieve the goals of the MDR and IVDR;

3. Welcomes the fact that notified body capacity for the MDR has now reached 50, which is considered an optimal level, and encourages the Commission and the Member States to foster further coordination and harmonisation of procedures and practices to ensure the smooth implementation of the legal framework of the MDR, with a view to increasing predictability for manufacturers and patients alike;

4. Remains concerned that currently, only 13 notified bodies have been designated by Member States to carry out assessments under the IVDR, and considers this should be increased to ensure optimal functioning of the legal framework for in vitro diagnostic medical devices;

5. Reiterates its call for a careful and thorough review of the regulatory framework provided by the MDR and IVDR based on the needs of patients and clinicians and with the aim of addressing the long-standing issues in the current system;

6. Urges the Commission to act without delay to further facilitate the implementation of the MDR and IVDR frameworks through delegated powers and tertiary legislation, in order to avoid unnecessary administrative burdens and increase the efficiency of the certification process;

7. Calls on the Commission to take all necessary steps to put in place clear, binding, harmonised and predictable timelines and evidence requirements for conformity assessment and certification, including clock stops, ensuring legal clarity so that manufacturers can plan effectively and secure necessary investments;

8. Calls on the Commission to further investigate establishing a coherent and transparent fee structure for notified bodies, with the aim of promoting predictability for manufacturers and ensuring a consistent cost system across the Union, while taking into account the different classes and specific characteristics of devices, especially those devices catering to very small patient groups;

9. Calls on the Commission to evaluate the need for recertification of low-risk, non-invasive, everyday devices and appliances (class I devices) within its evaluation of the MDR and IVDR, and to provide harmonised guidance on the recertification of such devices;

10. Strongly calls on the Commission to evaluate the inclusion of specific provisions for orphan devices and paediatric devices to ensure they receive appropriate attention and support within the regulatory framework;

11. Calls on the Commission to continuously monitor the availability of devices, particularly the last remaining devices of particular types, and to take appropriate action to keep them available in the EU market, through the full development of EUDAMED and, in the meantime, by taking additional actions where needed;

12. Recalls that a functioning system needs adequate human resources within the notified bodies, but also within the Commission;

13. Stresses that any review of the MDR and IVDR frameworks should be based on a comprehensive evaluation and subsequent impact assessment in order to ensure evidence based policymaking that is able to address the needs of all relevant stakeholders;

14. Strongly encourages the Commission to continue to use the powers at its disposal, including delegated powers and non-legislative actions, to continue to improve the implementation of the frameworks in the absence of an impact assessment and review;

15. Instructs its President to forward this resolution to the Commission and to the governments and parliaments of the Member States.