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21 June 2021
CARE, - Healthcare

There are over 500,000 medical devices in the European Market including medical oxygen containers, inhalers and adrenaline auto-injectors. These devices are essential for the millions of people who live with allergies and airways diseases. Therefore, their safety, efficacy and development should be well-regulated to ensure high quality of life and proper disease-management for all patients.

After a one-year delay due to complications related to the coronavirus pandemic, the new EU Medical Devices Regulation (MDR) came into effect on 26 May 2021. The regulation modernises the old rules that failed to ensure the safety standards necessary for such devices and subsequently, patients' right to safe and effective care.

Medical Devices Regulation Enters Application Phase

The new legislation brings EU policy in line with technological advances, progress in medical science, and integrates most of the feedback from EFA on patient’s priorities.

The Medical Devices Regulation:

  • Ensures assessment of medical devices entering the EU market, including a new pre-market scrutiny mechanism for high-risk devices and a conformity assessment procedure for medium and high-risk devices
  • Reinforces criteria for the designation and oversight capabilities of independent third parties, or notified bodies
  • Improves transparency by establishing an EU database on medical devices with a device traceability function
  • Requires universal labelling of medical devices for patient empowerment
  • Strengthens post-market vigilance, or assessment, through
    • new requirements for manufacturers
    • mandatory coordinated assessments of multinational clinical investigations
    • the establishment of a Medical Device Coordination Group (MDCG) comprised of a pool of experts to ensure harmonized implementation of guidelines

The Commission proposed to modernise the sector with the Medical Devices Regulation (MDR), adopted in May 2017 and applicable as of 26 May 2021.

EFA as a Key Stakeholder

The Commission has worked closely with all stakeholders to ensure a smooth and successful transition to a new regulatory framework. During the transitionary process, EFA contributed to the European Patients Forum’s recommendations to the Council. Through this we advocated for key, missing elements effecting patients’ safety and quality of life.

EFA sought to ensure that medical devices entering the EU market will be properly assessed and urged the European Medicines Agency (EMA) to designate special notified bodies to evaluate higher risk and reprocessed devices.

EFA also presented the need for patient empowerment through informed consent at the EFGCP-MedTech Europe workshop on Ethics, Quality and Oversight in the Clinical Development of Medical Devices. For patients to make informed decisions, EFA advocated for increased transparency on clinical evidence, device compliance assessments and post market vigilance including monitoring and reporting of all incidents with medical devices. Find the full presentation here.

Lastly, EFA stressed the importance of patient involvement in the design and implementation of regulations, ensuring patient-centred disease management. Specifically, EFA called for mandatory patient involvement in ethics committees, and participation in advisory committees for the assessment of medical devices and other groups discussing issues important to patients. Find EFA’s call for mandatory patient involvement here.

MDR in practice: What does it mean for patients with allergy and airways diseases?

EFA welcomes the MDR and its focus on patients’ needs and priorities. It is an essential piece of EU legislation aimed at ensuring patients' rights to safe, effective and innovative lifesaving and life-improving medical devices such as those used by allergy and airways diseases patients. But it also goes a step further, establishing a financial mechanism to ensure that patients are rapidly and effectively compensated if they receive defective devices.

EFA applauds the increased oversight for market introduction of new devices and clearer guidelines on manufacturing. Prior to MDR, no pre-market authorisation was required for novel devices.

The legislation now stipulates that notified bodies and the Medical Device Coordination Group, tasked with assessing the development life cycle of medical devices, shall be comprised of a pool of experts. EFA urges these bodies to actively include patients as experts in their own right.

EFA is pleased with the universal labelling of medical devices which will help patients across the Union easily identify ingredients, hazards and other device information via the traceability system and unique device identifiers. This increased transparency supports patient empowerment and encourages a patient-centred disease management paradigm at the EU level.

While EFA welcomes clear guidelines for manufacturers on device consistency and post-market evaluations, we continue to advocate for EU-level competencies in evaluating reprocessed devices. The MDR leaves the obligation to evaluate devices to national bodies, something that may result in irregularities and inequalities across member states. In EFA’s view, the next review of the legislation should explore having EMA as the centralised authority protecting the health and safety of patients using reprocessed medical devices.

Read the Press Release from the European Commission and the full legislation here.

Find guidance for manufacturers and notified bodies here.

Read more background information provided by EFA here.