MedTech Europe has called on the recently re-elected president of the European Commission (EC) to reform the regulatory system for medical technologies as a matter of urgency.
In a statement, the pan-European trade association welcomed President Ursula Von der Leyen’s new political policy, which promises to boost Europe’s competitiveness in global markets.
Presenting her political priorities for the EU 2024-2029 mandate to the European Parliament recently, Ms Von der Leyen said Europe’s competitiveness “needs a major boost”.
She acknowledged the need for “less reporting, less bureaucracy, and more trust, better enforcement and faster permitting”, and has promised to make business easier and faster and “get rid of the burdensome micromanagement”.
MedTech Europe applauded the Ms Von der Leyen for her strategy but said reforming the regulatory system for medical technologies “should be centre stage when implementing the Commission’s agenda”.
“Seven years after their publication, the Medical Devices (MDR) and In Vitro Diagnostic Medical Devices (IVDR) Regulations continue to hamper access to life-saving and life-sustaining medical technologies, as they are plagued by inefficient and unpredictable processes, skyrocketing cost of compliance, insufficient support for innovation, and a lack of accountable governance,” MedTech Europe said.
“The time has come to deliver urgent and effective reform and ensure that the regulations deliver for patients.”
It added that “Europe’s current political, legislative, and regulatory trajectory gives investors cause for hesitation”.
The organisation urged the re-elected president “to make an early and comprehensive reform of both the MDR and the IVDR central to her health and competitiveness agenda, taking into account input from their targeted evaluation”.
“Providing over 500,000 medical technologies and employing more than 880,000 people across the member states, the medical technology sector offers multiple solutions to existing health, societal, and economic challenges,” it said.
“An important prerequisite for this will be a European market that invites investment, fosters innovation, and provides a regulatory framework that is lean and efficient.
“This is a crucial time for the European Commission to champion policies that support patients and healthcare systems. Such policies need to ensure equitable access to top-tier healthcare for all patients in Europe, foster a unified digital health ecosystem across Europe, build resilient healthcare systems capable of withstanding future crises, and establish healthcare systems that are financially and environmentally sustainable.”
