EU Health groups propose solutions to MDR and IVDR concerns

October 2, 2023

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Frustration with the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) continues to mount among industry stakeholders over a lack of quick and economical regulatory approval processes. Since the inaction has resulted in some lifesaving products being pulled from the market, EU medical groups have begun to voice their own suggestions for how to rectify the issue.

Earlier this year, the European Health Commission provided an extension to May 2026 for companies to comply with the MDR and IVDR. However, industry stakeholders want the European Health Commission to do more to address their concerns with the regulatory framework.

Calls for structural reform

Along with 34 national associations, MedTech Europe, a European medical technology trade association, recently sent a letter to the European Commissioner for Health, Stella Kyriakides, calling for structural reform to both the MDR and IVDR. The groups hope that reforms will help ensure that medical technologies can reach healthcare systems across Europe in a timely manner.

In the letter, MedTech Europe and the other signatories called for the designation of a more efficient CE marking system to reduce administrative burdens. The groups have also called for the designation of an ‘innovation principle’ to connect emerging technologies more swiftly with patients and health systems through earlier dialogues with developers, and they’ve argued for the establishment of an accountable governance structure to oversee and manage the regulatory system and notified bodies.

Aligning with regulatory trends

The proposal to create an ‘innovation principle’ would align the MDR and IVDR more closely with current European Commission regulatory trends. Other pharmaceutical and medical device regulations that were introduced more recently than the MDR and IVDR by the Commission have sought to prioritise innovation and market access alongside product safety. For example, the European Clinical Trials Regulation (CTR) will create greater regulatory convergence and efficiency by streamlining the application process for clinical trial applications, allowing for companies to place a greater focus on innovation than on the administrative process.

Similarly, the European Commission’s recently proposed pharmaceutical regulation package also prioritises innovation and market access with measures to (1) provide incentives for companies that produce medicines that achieve public health objectives, (2) reduce the standard regulatory protection period, and (3) increase access to pharmaceuticals.

Meanwhile, another group of healthcare experts have published an academic article outlining recommendations on evaluating high-risk medical devices for children. Their recommendations also include the establishment of a task force on ‘orphan devices’, plus the designation of a clear definition for the term ‘orphan device’ itself (the name given to devices that treat rare health issues and are produced in small quantities). The group explains that resolving this issue would enable the taskforce and other groups to find ways to protect designated critical orphan devices.

Considering these calls for reform to the MDR and IVDR and the fact that Commissioner Kyriakides has admitted more changes to the regulations are likely needed, manufacturers should continue to take advantage of opportunities to engage with regulators and provide input on the reform process.

Ensuring eligibility and increased regulatory obligations

It is also critical for manufacturers to ensure they have completed the necessary administrative steps to be eligible for the MDR transition extension. Companies should also ensure they understand if they are eligible and what category of eligibility they might fall into per the Medical Device Directive.

In proposing the establishment of a new accountable governance structure to oversee regulatory agencies and notifying bodies, industry members should understand that this will likely lead to significantly increased regulatory obligations for manufacturers amid greater enforcement power for that entity.

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Tags: EU MDR, Europe, health, Health and wellness, health concerns, Healthcare, pharmaceuticals, regulation