What changed

B100121/2024

B100124/2024

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

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

– 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 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 (the Medical Devices Regulation – MDR),

– having regard to Regulation (EU) 2017/7452017/746 of the European Parliament and of the Council of 5 April 2017 on medicalin devices,vitro amendingdiagnostic Directivemedical 2001/83/EC,devices Regulationand (EC)repealing NoDirective 178/200298/79/EC and RegulationCommission (EC)Decision No2010/227/EU 1223/2009(the andIn repealingVitro CouncilDiagnostic DirectivesMedical 90/385/EECDevices andRegulation 93/42/EEC– (MDR),IVDR),

– 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) 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) 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) 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 the Commission’s 2023 report on the implementation of the MDR and the IVDR,

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

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

A. whereas medicalaccess devicesto playquality amedical pivotaldevices roleand in thevitro healthcaremedical industry,devices facilitatingis theindispensable diagnosis,for prevention,patients’ monitoringhealth and treatment of variousfor medicalhealthcare conditions;systems;

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

B. whereas more than 500 000 different medical devices are marketed in the EU, covering a broad range of products from plasters to x-ray machines, and they are used for diagnosis, prevention, treatment and rehabilitation and, overall, to improve the quality of life of patients and the work of healthcare professionals and carers;

C. whereas after a series of scandals, in which patient safety was jeopardised for profits, including cases of leaking breast implants, the new MDR and IVDR were agreed;

C. whereas large differences still remain in access to medical devices across the EU, leading to healthcare inequalities;

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;

D. whereas the MDR and the IVDR were adopted to strengthen the regulatory framework in response to several scandals involving the use of unsafe medical equipment, such as hip and breast implants; whereas patient safety and quality standards should never be compromised;

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;

E. whereas the deadlines set in the MDR and the IVDR have been extended several times to give more time to device developers and notified bodies, and to avoid shortages of devices;

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;

F. whereas despite these deadline extensions, healthcare professionals have reported shortages of medical devices and in vitro medical devices, especially for paediatric and orphan devices;

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;

G. whereas it is still uncertain exactly which medical devices are at risk of withdrawal and shortages, because of a lack of transparency from notified bodies;

H. whereas somethe ofmajority theof manufacturersdevelopers of medical devices remainand persistentlyin unpreparedvitro tomedical meetdevices theare requirementssmall ofand themedium-sized regulations;enterprises with limited resources;

I. whereas some of the notified bodies who carry outprocess theof assessmentapplying andfor certification of medical devices havecan createdbe anburdensome, unpredictablelengthy workand environmentexpensive, forespecially manufacturersin ofsome medicalMember devices;States;

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;

J. whereas many stakeholders, such as developers, patient organisations and healthcare providers, have reported difficulties in navigating the regulatory framework for medical and in vitro medical devices;

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

K. whereas increasing numbers of medical devices are supplied by producers in non-EU countries, some of which are autocratic regimes, raising concerns about the protection and possible misuse of personal medical data collected by medical devices;

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;

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

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;

2. Welcomes the increased capacity of notified bodies; invites the Member States and the Commission to assess whether measures can be taken to further improve the speed and efficiency of these notified bodies without jeopardising patient safety;

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’;

3. Stresses the need for more transparency, information and guidance from the authorising authorities to manufacturers undergoing the certification process, including information regarding notified body fees and fee structures; underlines that this is already possible under the current regulation;

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;

4. Further stresses the need for greater transparency and better access to information for patients organisations and healthcare professionals from notified bodies and from national authorities;

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;

5. Underlines that product updates or adjustments should not necessarily lead to the need for a full recertification of the product; calls, in this regard, for harmonised guidance to ensure consistency for medical device 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;

6. Welcomes the non-legislative actions already initiated by the Commission and calls for further actions to be taken to counter shortages and reduce the administrative burdens, where possible;

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;

7. Welcomes the pilot programme by the European Medicines Agency to support manufacturers producing and notified bodies certifying orphan devices in the processes of development and assessment;

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

8. Notes that post-authorisation market surveillance can be burdensome, and that a more harmonised approach could benefit both developers and the Member States;

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;

9. Recalls that the MDR should be evaluated by 2027 at the latest; stresses, in this regard, the need for a proper evaluation and impact assessment; further stresses that all relevant stakeholders should be part of the evaluation process;

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;

10. Believes that reducing administrative burdens and ensuring access to medical devices throughout the EU should be key considerations in the evaluation of the regulation;

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;

11. Believes that the evaluation should also examine dependency on non-EU countries, including the protection of personal medical data;

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

12. 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 change;

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

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

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