What changed

B100122/2024

B100126/2024

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

The European Parliament,

– 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 (Medical Devices Regulation, MDR), and 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 the Treaty on the Functioning of the European Union, in particular Article 168 thereof,

– having regard to the Commission statementCharter of 9 OctoberFundamental 2024Rights onof the urgent needEuropean toUnion, revisein theparticular MedicalArticle Devices35 Regulation,thereof,

– having regard to Regulation (EU) 2017/745 of the proposalEuropean forParliament rejectionand of the RecommendationCouncil forof second5 readingApril 2017 on inmedical vitrodevices diagnostic(Medical medicalDevices devices,Regulation),

– 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 (In Vitro Medical Devices Regulation),

– having regard to Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions,

– having regard to Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices,

– 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) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices,

– 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 Rule 136(2) of its Rules of Procedure,

A. whereas theaccess legislationto onsafe and effective medical devices and in vitro medical devices wasplays reviseda crucial role in 2017providing throughhigh thequality MDRtreatment and care for patients in the IVDR;EU;

B. whereas the new legislative framework of 2017, which replaced the existing directives with regulations, was a reaction to certain events, first and foremost to a company’s marketing non-medical grade silicone gel breast implants in blatant and intentional violation of the regulatory framework; whereas there have been various violations under the new regulatory framework during the so-called pandemic;

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;

C. whereas the regulations have placed aMedical considerableDevices regulatoryRegulation burden(MDR) onand the producersIn ofVitro medicalMedical devicesDevices andRegulation in(IVDR) vitrowere medicaladopted devices;to whereasstrengthen the MDRlegal framework and theenhance IVDRpatient havesafety createdin aresponse considerableto administrativea burdennumber forof regulators;scandals whereasinvolving theunsafe combinedmedical burdenequipment, hassuch createdas bothhip- aand backlogbreast ofimplants, requiredand certificationsto withinreduce the industry andnumber anof administrativeobsolete bottleneckmedical fordevices issuingon suchthe certifications;market;

D. whereas this backlog has affected the market for medical devices and in vitro medical devices; whereas there is a shortage of certain medical devices and in vitro medical devices; whereas producers’ innovative capacity has been impaired;

D. whereas incomplete applications with which manufacturers have not provided notified bodies with sufficient scientific evidence and technical detail are among the main reasons for the current delays in issuing CE certificates;

E. whereas a prolonged waiting time for such products, shortages and a lack of innovation due to the inability to cope with bureaucratic obstacles harms patients as consumers of medical products; whereas such harm could ultimately result in an unnecessary loss of life;

E. whereas the implementation deadlines set in the MDR and IVDR were extended several times to increase the capacity of notified bodies and to help the industry to adjust to the new rules in order to avoid shortages of medical devices;

F. whereas the Commission needs to have finalised an evaluation of the regulations by 27 May 2027 under Article 121 MDR and Article 111 IVDR;

F. 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 free scientific advice;

1. Considers that both the IVDR and the MDR have created very burdensome bureaucracy, which is neither in the interest of the producers nor in the interest of patients as consumers; suggests that any inappropriate or disproportionate regulatory burden be lifted as soon as possible; underlines that there is now an urgent need for revision of both the IVDR and the MDR;

G. whereas although there is now an optimal number of notified bodies established under the MDR, issues remain in terms of the inconsistency of decisions, the lack of transparency regarding decisions and limited capacity for post-market surveillance; whereas more notified bodies still need to be established under the IVDR and the consistency and transparency of their decisions enhanced;

2. Recalls that as far back as in 2017 a Parliament minority moved to reject the new framework as too excessive a regulatory burden and too expensive for producers of medical devices to comply with; considers that law is good law when it can stand the test of time; recalls that perceived legislative necessity, as so often encountered in real or perceived crises, should not trump the established rules of proper lawmaking to the detriment of the smooth functioning of parliamentary democracy;

H. whereas there is no harmonised mechanism to monitor interruption of supply of devices and whereas the limited requirement for manufacturers to give prior notice about any interruption of supply of certain critical medical devices or in vitro medical devices was only introduced with Regulation (EU) 2024/1860 and will only take effect in January 2025; whereas to ensure patient health protection more transparency provisions linked to supply chain stability are needed so as to understand what types of devices are at serious risk of market withdrawals and shortages;

3. Notes that proposals have been made to remedy the problems through tertiary legislation, thereby circumventing the ordinary legislative procedure; underlines that the shortcomings of Union secondary legislation cannot be corrected by tertiary-level legislation, as this would ultimately mean substituting Parliament’s lawmaking capacity with executive decrees; warns against the widespread and excessive use of delegated acts as a means of repairing flawed legislation;

1. Stresses its continued support for the swift implementation of the MDR and IVDR and underlines that patient safety must never be compromised and that equal access to quality medical devices must be ensured throughout the EU;

4. Calls on the Commission not to make use of the full time frame granted for evaluation of the IVDR and the MDR, but instead to speed up the process as much as possible; notes that the Commission has been called upon to come up with a proposal within a hundred days of the start of the new Commissioners’ term of office;

2. Regrets the continuing risks of device shortages, notably in the areas of paediatric and orphan diseases, as a result of the suboptimal implementation of the legal framework;

5. Calls on the Commission to immediately present an amendment to address the glaring shortcomings of current legislation in the first half of 2025, so that businesses, patients as consumers and healthcare authorities can enjoy immediate relief; calls on the Commission to conduct its evaluation, and present a full legislative proposal, as swiftly as possible;

3. Stresses the urgent need for medical device supply chains to be transparent to prevent device shortages and the need for closer cooperation and stricter reporting obligations, including through the Medical Devices Coordination Group (MDCG) and the Executive Steering Group on Shortages of Medical Devices;

6. Suggests including in its proposal an accelerated certification procedure for innovative medical products, abolishing the re-certification requirement for lower-risk products and abolishing the certification requirement for niche-products;

4. Underlines that all relevant information on the processes and decisions of notified bodies regarding the certification of medical devices must be in the public domain and accessible to all the relevant stakeholders; in this regard, reiterates the need for a swift roll-out of a comprehensive, fully functional, and user-friendly European database for medical devices (EUDAMED) that provides complete information on all medical devices available on the EU market and adheres to the highest standards of transparency and accessibility of information;

7. Considers that, as a prerequisite, there is already a strong and functioning civil liability regime in place that protects consumers, allowing certain regulatory requirements to be relaxed;

5. Welcomes the fact that the capacity of notified bodies has significantly increased in recent months and urges the Member States and the Commission to ensure a coordinated approach and harmonisation to improve the efficiency and predictability of decisions taken by notified bodies as well as their fee structure;

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

6. Calls on the Commission to propose specific timeframes for conformity assessments linked to different classes of medical devices, to ensure predictability for developers, and to envisage the possibility of accelerated timelines when devices are linked to health emergencies or where there is robust scientific evidence of an extraordinary benefit for patients in areas of high unmet medical need;

7. Reiterates that any incentives related to orphan medical devices must be based on clear eligibility criteria, be linked to a prudent system that prevents misuse through an artificial ‘orphanisation’ of the devices, and their use must be registered centrally to ensure better evidence generation throughout the EU;

8. Underlines the need for more optimal stakeholder involvement, including within the notified bodies, and calls on the Member States and Commission to ensure that patients and healthcare professionals have access to all relevant documents and decisions;

9. Underlines that product updates or adjustments should not necessarily lead to a need for an entire re-certification of the product, and in this regard calls for tertiary legislation to harmonise such provisions and ensure consistency for developers across the EU;

10. Calls on manufacturers of medical devices to coordinate more closely with national authorities and prioritise patient safety by ensuring the generation of robust evidence and meeting the requirements of the MDR and IVDR without further delay;

11. Welcomes the non-legislative actions already initiated by the Commission and urges more activities particularly vis-à-vis transparency and post-market surveillance; calls on the national competent authorities to significantly strengthen post-market surveillance activities and communication to patient organisations and healthcare professionals and the general public on risks to health or safety associated with marketed devices; calls on the authorities to ensure that manufacturers adhere to strict, clearly established timelines for implementing corrective actions, including prompt communication and follow-up with all potentially affected patients;

12. Reiterates the need for a thorough evaluation and impact assessment of the MDR and IVDR before the potential reopening of the regulations and underlines that all the relevant stakeholders, including patients and healthcare professionals, must be involved in the evaluation process;

13. Underlines that any potential revision of the medical devices framework must first and foremost uphold high patient safety standards, be based on evidence collected in the evaluation and impact assessment and ensure accompanying measures to support the transition;

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