What changed

B100123/2024

European Parliament resolution on the urgent need to revise the Medical Devices Regulation

– 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 theCouncil Commission’sRegulation proposal(EU) for2022/2372 aof regulation24 ofOctober the2022 Europeanon Parliamenta andframework of the Councilmeasures amendingfor Regulationsensuring (EU)the 2017/745supply andof (EU)crisis-relevant 2017/746medical ascountermeasures regardsin the transitional provisions for certain medicalevent devicesof anda inpublic vitrohealth diagnosticemergency medicalat devicesUnion (COM(2023)0010),level,

– having regard to Regulation (EU) 2022/123 of the European MedicinesParliament Agency’sand 2023of Annualthe ReportCouncil andof its25 reviewJanuary 2022 on marketa accessreinforced androle safetyfor concernsthe European Medicines Agency in crisis preparedness and management for medicinal products and medical devices,

– having regard to Rule 136(2) and (4) of its Rules of Procedure,

– 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,

A. whereas medical devices and in vitro diagnostic medical devices play a crucial role in high-quality healthcare, directly affecting the health, safety and well-being of millions of patients across the EU;

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

B. whereas approximately 500 000 different medical devices are available on the EU market, covering a broad range of technologies, from contact lenses to pacemakers, and serving different purposes, including diagnosis, prevention, treatment, rehabilitation and improving the quality of life of patients and the work of healthcare professionals and carers;

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;

C. whereas disparities in access to medical devices persist across Member States, affecting patient care and leading to health inequalities; whereas such disparities underscore the need for improved availability and affordability of crucial devices;

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;

D. whereas the MDR and IVDR were adopted to strengthen the regulatory framework for medical devices and in vitro diagnostic medical devices, as a response to several high-profile scandals with unsafe medical equipment, with the purpose of ensuring higher standards of safety, transparency and clinical performance while also fostering innovation in the sector;

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;

E. 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;

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;

F. whereas despite these aims, significant challenges have been encountered in implementing the MDR and the IVDR, not only leading to delays but also resulting in failures to achieve certification and approval of medical devices and in vitro diagnostic medical devices, particularly impacting small and medium-sized enterprises (SMEs), as well as resulting in shortages of medical devices and in vitro diagnostic medical devices, thus restricting patient access to innovative and life-saving therapeutic and diagnostic technologies;

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;

G. whereas many stakeholders, in particular small and medium-sized manufacturers, notified bodies and healthcare providers, have reported difficulties in navigating the complex regulatory procedures under the current MDR and IVDR framework, with potential risks posed to the continuous availability of life-saving medical devices and critical in vitro diagnostic tests in the EU;

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

H.G. whereas thesome transitionalnotified periodsbodies, forespecially theones implementationdealing ofwith the MDR and IVDRIVDR, have beenstruggled extendedto onmeet numerousthe occasionsincreased todemand addressfor issuescertification includingowing theto capacitya oflack notifiedof bodiescapacity and to allow industry moreresources, timewhich tohas adaptresulted toin newsignificant rulesdelays in ordergetting devices to preventthe devicesEU beingmarket, withdrawnand fromat thetimes EUcreating market;bottlenecks;

I.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, alongside inconsistency in decisions and a lack of transparency in relation to the work of the notified bodies;unpredictability;

J. whereas there is a need for the regulatory frameworks to better accommodate innovative devices that address unmet medical needs and provide better prioritisation and fast-track pathways;

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;

K. whereas the Commission initiated non-legislative actions to support the transition to the MDR and IVDR, focusing in particular on the availability of medical devices on the market, the preparedness of notified bodies, the development of orphan and paediatric devices, SME support and the waiving of fees for scientific advice in critical areas where, despite these measures, financial and administrative challenges persist, particularly in the orphan and paediatric sectors;

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;

L. whereas the deadlines for implementing the MDR and IVDR have been extended multiple times to help the industry adapt to new regulations, to prevent market withdrawals and to ensure the continuous supply of devices; whereas these extensions were critical in maintaining public health protection during the COVID-19 pandemic;

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;

M. 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;

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

N. whereas it is important to ensure that patients and healthcare professionals have access to all relevant documents and decisions taken by the notified bodies;

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;

1. Calls on the Commission to propose, by the end of Q1 2025, delegated and implementing acts to the MDR and the IVDR to address the most pressing challenges and bottlenecks in the implementation of the legislative frameworks and to propose the systematic revision of all relevant articles of these regulations, accompanied by an impact assessment, to be conducted as soon as possible;

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;

2. Calls on the Commission to make full use of legislative and non-legislative tools to resolve issues of divergent interpretation and of practical application to streamline the regulatory process, improve transparency, and eliminate unnecessary administrative work for notified bodies and manufacturers, particularly SMEs, without compromising patient safety;

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;

3. Deplores the risk of shortages of medical devices and the lack of access to certain medical devices and in vitro diagnostics in parts of the EU; stresses that access to and quality of healthcare, including medical devices and in vitro diagnostics, should not depend on where in the EU a patient is located;

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;

4. Encourages the notified bodies to ensure that there are sufficient resources to meet the market demand in a timely manner; in this regard, calls on the Commission and the Member States to enhance support and cooperation to ensure that the notified bodies have the optimal capacities and capabilities to fully implement the regulatory framework;

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;

5. Advocates the creation of transparent and binding timelines, including clock stops for procedural steps in conformity assessment by notified bodies, thus creating predictability and certainty for manufacturers regarding the market access procedure and its duration within the EU;

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;

6. Calls for transparency in notified bodies’ fees and fee structures, to allow economic operators to compare notified bodies and make informed choices, ensuring that fees remain a fair compensation for the public service provided;

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;

7. Stresses the need to eliminate the unnecessary re-certification of products, and underlines that certain product updates or adjustments should not necessarily lead to an entire re-certification of the product; stresses the need to harmonise such provisions and ensure consistency across the EU; calls for cooperation between the competent authorities and advisory bodies responsible for other regulatory frameworks, and stresses the need for products to be classified correctly and consistently;

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;

8. Strongly calls on the Commission to consider fast-track and prioritisation pathways for the approval of innovative technologies in areas of unmet medical need and for devices linked to health emergencies;

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;

9. Highlights the need to establish a clear working definition of ‘orphan device’, as determined by the Medical Device Coordination Group in the MDR and IVDR, to facilitate the adoption of harmonised measures across the EU; additionally calls for a robust system to prevent misuse through artificial ‘orphanisation’;

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;

10. Calls for the introduction of adapted rules for orphan and paediatric medical devices, without compromising patient safety, and emphasises the need for more efficient conformity assessment procedures tailored to medical devices and in vitro diagnostics serving relatively small markets, such as products for the treatment of children or rare diseases;

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;

11. Calls on the Commission to facilitate the collection of clinical data from existing national registries for small patient groups treated or diagnosed with orphan and paediatric devices, in compliance with the protection of personal data; recognises the challenges faced by various SMEs in adapting to the legal frameworks; invites the Member States and the Commission to develop specific measures to support SMEs, including the provision of model application documents and forms, regulatory guidance and other assistance to reduce the costs and complexity of the regulatory frameworks;

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;

12.11. 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; in this regard, calls formarket, anthrough urgentthe full implementationdevelopment of EUDAMED, which will enable information about medical devices and manufacturers to be processed to enhance transparency, provide better access toEUDAMED informationand, forin the public and healthcare professionals,meantime, andby enhancetaking coordinationadditional betweenactions Memberwhere States;needed;

13. Emphasises that any new rules or changes to existing rules must come with an appropriate transition period to allow all stakeholders sufficient time to adjust to the changes;

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

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

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.