What changed

B100126/2024

B100121/2024

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

– having regard to the Charter of Fundamental Rights of the European Union, in particular Article 35 thereof,

– having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devicesdevices, (Medicalamending DevicesDirective Regulation),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 (Inand Vitrorepealing MedicalDirective Devices98/79/EC Regulation),and Commission Decision 2010/227/EU (IVDR),

– 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 access to safe and effective medical devices and inplay vitroa medicalpivotal devicesrole playsin athe crucialhealthcare roleindustry, infacilitating providingthe highdiagnosis, qualityprevention, treatmentmonitoring and care fortreatment patientsof invarious themedical EU;conditions;

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;

B. whereas people rely on these devices every day and expect them to be safe, available and affordable;

C. whereas the Medical Devices Regulation (MDR) and the In Vitro Medical Devices Regulation (IVDR) were adopted toafter strengthena theseries legalof frameworkscandals, andin enhancewhich patient safety in response to a number of scandals involvingwas unsafejeopardised medicalfor equipment,profits, suchincluding ascases hip-of andleaking breast implants, and to reduce the number of obsoletenew medicalMDR devicesand onIVDR thewere market;agreed;

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;

D. whereas these regulations updated the rules on the placing on the market of medical devices for human use and their accessories, as well as the rules for making such devices and accessories available on the market and putting them into service in the EU; whereas they also contain rules on how clinical investigations concerning such devices and accessories are carried out in the EU;

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;

E. whereas the main aim of the regulations is to improve patient safety by introducing more stringent procedures for conformity assessment (to ensure that unsafe or non-compliant devices do not end up on the market) and post-market surveillance;

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;

F. whereas in 2020, amending Regulation (EU) 2020/561 was adopted to allow EU Member States and their authorities and institutions to prioritise the fight against the COVID-19 pandemic; whereas the application of certain of the MDR’s rules was deferred by one year to ensure the smooth functioning of the EU’s internal market, to maintain a high level of public health protection and patient safety, to provide legal certainty and to avoid potential market disruption during the pandemic;

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;

G. whereas in 2023, amending Regulation (EU) 2023/607 was adopted as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, permitting extensions where needed;

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;

H. whereas some of the manufacturers of medical devices remain persistently unprepared to meet the requirements of the regulations;

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;

I. whereas some of the notified bodies who carry out the assessment and certification of medical devices have created an unpredictable work environment for manufacturers of medical devices;

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;

J. whereas there is no clarity on any actual shortages of medical devices nor on risks posed by shortages for specific therapeutic areas; whereas more factual information is needed to properly address the situation;

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;

K. whereas the European Database on Medical Devices (EUDAMED) is an integral part of the MDR and the IVDR;

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;

1. Expresses its continued support for the strong and strict protection of patient health and safety, including through the correct implementation of the MDR and the IVDR; underlines that patient safety must never be compromised;

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;

2. Regrets possible shortages of medical devices and risks thereof, notably in the areas of paediatric care and orphan devices, resulting mainly from a suboptimal implementation of the legal framework;

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;

3. Points out that the President of the European Commission has tasked the Commissioner-designate for Health and Animal Welfare with ensuring ‘the availability and competitiveness of medical devices, including by stepping up the implementation of current framework and evaluating the need for potential legislative changes’;

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;

4. Welcomes the Commission’s ongoing non-legislative actions to support the transition to the new regulations, including advice and guidance on the clinical evidence needed for fee-free conformity assessment, training, coaching and internship activities for notified bodies and conformity assessment bodies, and support for the development of innovative and orphan devices;

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;

5. Stresses that the ongoing evaluation of the MDR and IVDR will generate much needed data and should be concluded and its results fully taken into account in any future revision of the MDR and IVDR, which should be accompanied by the customary full impact assessment;

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;

6. Underlines that citizens, including patients in particular, as well as governments, civil society organisations and manufacturers of medical devices, have a right to information on the processes used by notified bodies for the certification of medical devices, including information on the timelines and fees;

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;

7. Regrets the fact that notified bodies seem to have been misusing their critical position in the value chain, and points to the fact that this endangers patient safety and treatment options;

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;

8. Expects all manufacturers of medical devices to be able to meet the requirements of the MDR and IVDR without any further delay;

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;

9. Expects all notified bodies to ensure, through their work, that safe and reliable medical devices obtain timely and affordable access to the market, in a predictable and consistent manner;

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;

10. Calls on the Commission to step up its efforts to ensure that the notified bodies use common and transparent working methods; invites the Commission to explore the possibility of ensuring more harmonisation, transparency and predictability of the certification processes, timelines and fees of the notified bodies, by means of implementing or delegated acts;

11. Calls on the Commission also to investigate ways to increase the transparency of the entire certification process conducted by notified bodies, to ensure that the public, civil society, academia and governments can scrutinise the work done; stresses that this would enhance the safety of the medical devices;

12. Calls for the full implementation of EUDAMED in accordance with the agreed timeline;

13. Underlines that any future legislative proposal on medical devices should be patient-centred and should put patient safety first;

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