What changed

B100128/2024

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

The European Parliament,

– having regard to Article 168 of the Treaty on the Functioning of the European Union, which recognises the EU’s competenceand in the fieldparticular ofArticle public168 health,thereof,

– having regard to Article 114 of the Treaty on the Functioning of the European Union,

– 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),

– 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),

– having regard to Regulation (EU) 2024/18602023/607 of the European Parliament and of the Council of 1315 JuneMarch 20242023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in the event oftransitional interruptionprovisions orfor cessationcertain ofmedical supplydevices and the transitional provisions applicable to certain in vitro diagnostic medical devices,

– having regard to its position at first reading of 16 February 2023 on the proposal for a regulation of the European Parliament and of the Council 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 the information note from several Member States on the miscellaneous item submitted to the Employment, Social Policy, Health and Consumer Affairs Council on 30 November 2023 concerning the implementation of the MDR and the IVDR,

– having regard to the Commission’s proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (COM(2023)0010),

– having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC,

– having regard to the European Medicines Agency’s 2023 Annual Report and its review on market access and safety concerns for medical devices,

– having regard to the Commission proposal of 3 May 2022 for a regulation of the European Parliament and of the Council on the European Health Data Space (COM(2022)0197),

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

– having regard to the Pharmaceutical Strategy for Europe, adopted by the Commission on 25 November 2020 (COM(2020)0761),

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 the statement by the Commission of 9 October 2024 on the urgent need to revise the Medical Devices Regulation,

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;

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

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;

A. whereas medical devices play a crucial role in public health by ensuring the effective diagnosis, treatment and monitoring of patients and users;

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;

B. whereas the MDR was intended to improve the safety and performance of medical devices in Europe; whereas the requirements imposed on the notified bodies responsible for certification have led to a drastic reduction in the number and availability of notified bodies, even though they play a critical role in the market access process for medical devices;

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;

C. whereas problems relating to the implementation of the MDR and delays in its application have caused difficulties for the healthcare sector and for the businesses concerned, leading to shortages, in particular for the hospital market and the paediatric sector;

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;

D. whereas numerous stakeholders, including healthcare professionals, industry representatives and patients, have reported shortages, delays in the authorisation of medical devices, and barriers to innovation;

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;

E. whereas the increase in regulatory requirements has led to additional costs for manufacturers, particularly small and medium-sized enterprises (SMEs), thereby reducing their ability to innovate and remain competitive;

H. 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 withdrawn from the EU market;

F. whereas the COVID-19 pandemic had a major impact on the supply and use of medical devices in the Member States, whereas it highlighted the fragility of the supply of essential medical devices and emphasised the need to guarantee a robust and diversified supply chain by maintaining or restoring design, innovation and production capacities in the EU;

I. 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;

G. whereas delays in obtaining or renewing CE marking for medical devices could lead to shortages in hospitals and for patients requiring urgent treatment;

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;

H. whereas innovative, safe and effective medical devices are essential for guaranteeing the quality of patient care and supporting the resilience of healthcare systems;

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;

I. whereas certain provisions of the Green Deal could affect the availability of certain medical devices, in particular those containing per- and polyfluoroalkyl substances;

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;

J. whereas the ‘one substance, one assessment’ principle could help to improve the safety of medical devices by making it possible to judge whether a particular substance should be authorised on the basis of the criticality of the medical device in which it is used;

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;

K. whereas the EU lacks skilled independent experts who are able to carry out certification audits for notified bodies;

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;

L. whereas, as a result of the lack of certification timelines that should be binding for notified bodies and for manufacturers, these parties and various other stakeholders have reported difficulties in planning their activities, and this causes shortages and jeopardises the availability of innovative products, thus penalising patients;

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;

M. whereas the innovative regulatory framework referring to substance-based medical devices, which was introduced by the MDR, is intended to encourage the development of therapies that act through non-pharmacological, non-immunological and non-metabolic means; whereas guidelines and decisions issued by national authorities set limits that classify products falling within the scope of the MDR under other regulatory categories, which goes against the EU legislator’s aim of fostering therapeutic innovation;

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;

N. whereas the EUDAMED database was supposed to be operational by May 2022, but delays have resulted in a phased roll-out and only partial deployment;

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;

O. whereas the in vitro medical devices sector faces particular challenges, given that far more effort is required to achieve compliance under the IVDR than under the previous directive;

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;

P. whereas e-health applications of which the purpose corresponds to the definition of medical devices are not currently certified, and therefore potentially endanger users’ health data;

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;

1. Expresses its deep concern about the negative effects of delays in the implementation of the MDR, in particular on innovation, on the competitiveness of SMEs and certification companies, and on patient access to essential 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;

2. Calls on the Commission to urgently revise the MDR in order to simplify approval procedures, in particular for low-risk devices and technological innovations, reduce the administrative burden, and lessen unmet medical needs;

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;

3. Invites the Commission to introduce a temporary mechanism, complementary to the amendments introduced by Regulation (EU) 2024/1860, to enable the appropriate extension of existing certifications for medical devices pending the full implementation of the new certification framework, and asks that the Commission improve and promote the streamlining of the certification process for devices in order to prevent critical shortages and ensure safe access to medical devices for patients;

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;

4. Stresses the importance of striking a balance between rigorous safety requirements and rapid, efficient approval processes, particularly for innovative devices with significant benefits for users;

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’;

5. Calls for the introduction of specific support measures for SMEs, including technical and financial assistance to help them comply with the new regulatory requirements without undermining their competitiveness;

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;

6. Calls for specific measures to be taken to strengthen, maintain and adapt the capacity of notified bodies to handle innovation;

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;

7. Suggests that consideration be given to a fast-track procedure for the approval of vital medical devices in times of health crisis, noting that it would be appropriate to focus on the shortages of medical devices and in vitro diagnostic medical devices created by the transition to the MDR and the IVDR;

12. 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 for an urgent full implementation of EUDAMED, which will enable information about medical devices and manufacturers to be processed to enhance transparency, provide better access to information for the public and healthcare professionals, and enhance coordination between Member States;

8. Stresses the need to protect health data collected by e-health applications by expressly including these applications in the scope of the revised MDR and by laying down appropriate provisions on them;

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;

9. Calls on the Commission and the Member States to strengthen the resilience of medical device supply chains, including through diversified production and better European coordination, in order to avoid shortages;

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

10. Stresses the importance of transparency in the certification process for medical devices and invites the Commission to publish regular progress reports on the implementation of the MDR;

11. Stresses the need for predictable timelines and costs for the assessment of technical documentation, and thus the need to adopt binding legislative measures requiring notified bodies and manufacturers to respect their mutual obligations so that certification can be obtained within the agreed time frame;

12. Emphasises that it is important for the Commission and other regulatory bodies to promote the correct classification of products, thus embracing the scope for innovation provided by EU legislator and to ensure that there are no obstacles to the development of innovative therapies originating from the medical device sector;

13. Points out that EUDAMED’s transparency may be exploited in order to interfere with and undermine the EU and the Member States; considers, given this, that the information made available should be tailored to the audience;

14. Calls on the Commission to submit to Parliament, without delay, a detailed report on shortages directly or indirectly attributable to the implementation of the MDR, listing the devices concerned and the health consequences for patients and users;

15 Calls for increased collaboration between the EU, national regulatory agencies and healthcare stakeholders to ensure harmonised implementation of the MDR;

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