MedTech: Call for Structural Reform of MDR and IVDR

MedTech Europe, along with 34 national associations, published an open letter to EU Health Commissioner Stella Kyriakides on 14 September 2023.

In the 3-page letter, the stakeholders, on behalf of the MedTech industry, point out that an urgent and comprehensive reform is necessary to address the challenges created by the Medical Devices Regulation (MDR (EU) 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR (EU) 2017/746).

One of the original objectives of the regulations, to establish a stable and transparent regulatory framework that ensures a high level of safety and health while supporting innovation, has not been implemented sufficiently after more than six years, they argue. What is problematic is that both medical technology innovations already on the market and future innovations have a hard time reaching European patients and healthcare systems.

According to the trade groups, structural problems in the legal framework of the MDR and IVDR are to blame. They are therefore calling for comprehensive changes in the regulations to minimise the lack of agility and innovation.

Trade associations are calling for three main improvements:

• A more efficient and fit-for-purpose CE marking system,
• a system that supports innovation in medical technology, and
• a single structure to oversee and manage the regulatory system.

In addition to the demands, the open letter also proposes solutions and measures to improve the current situation.

Stella Kyriakides was offered the cooperation and support of the industry:"We stand ready to work together with you and the European Commission services to address this pressing situation and work toward the comprehensive structural reform necessary to achieve the stated objectives of the regulations.."

Source:

MedTech Europe: Open Letter