What changed

B100127/2024

B100122/2024

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

The European Parliament,

– having regard to Article 5(3) of the Treaty on 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 (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 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),

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

– having regard to Regulation (EU) 2017/746 of the Europeanproposal Parliamentfor andrejection of the Council ofRecommendation 5for Aprilsecond 2017reading on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (the In Vitro Diagnostic Medical Devices Regulation),devices,

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

A. whereas public health is and should remain primarily a competence of the Member States;

A. whereas the legislation on medical devices and in vitro medical devices was revised in 2017 through the MDR and the IVDR;

B. whereas the implementation of the Medical Devices Regulation has triggered many challenges for manufacturers, notified bodies and healthcare providers;

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;

C. whereas the current complex and costly regulatory framework jeopardises the availability and affordability of medical devices for patients;

C. whereas the regulations have placed a considerable regulatory burden on the producers of medical devices and in vitro medical devices; whereas the MDR and the IVDR have created a considerable administrative burden for regulators; whereas the combined burden has created both a backlog of required certifications within the industry and an administrative bottleneck for issuing such certifications;

1.D. Callswhereas onthis backlog has affected the Commissionmarket tofor proposemedical adevices revisionand ofin thevitro Medicalmedical Devicesdevices; Regulationwhereas andthere theis Ina Vitroshortage Diagnosticof Medicalcertain Devicesmedical Regulationdevices toand addressin thevitro challengesmedical thatdevices; havewhereas emergedproducers’ ininnovative theircapacity implementation;has been impaired;

2. Underlines that the revision of these regulations should take into consideration the views of the stakeholders along the entire value chain;

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;

3. Stresses that this revision should focus on ensuring the timely availability of medical technologies, a more predictable regulatory system and a reduction in the administrative burden for manufacturers, especially small and medium-sized enterprises;

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;

4. Emphasises that this revision should also contribute to increasing the competitiveness of the sector, while ensuring a high level of patient safety;

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;

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

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;

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;

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;

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;

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;

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;

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