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Diving brief:

• The European Parliament called for the publication of reforms to the Regulation on Medical Devices and In Vitro Diagnostics (MDR/DRIV) by the end of the first quarter of 2025.
• In a joint motion published on Monday, Parliament called on the European Commission to publish acts that “address the most pressing challenges and bottlenecks” in regulation and propose “the systematic review” of the legislation.
• MedTech Europe welcomed Parliament’s message and launched his own appeal for the commission to quickly resolve challenges and bottlenecks using “any means having sufficient legal weight”.

Dive overview:

The joint motion for a resolution published by Parliament calls for a rapid change to the MDR and IVDR. Significant implementation challenges cause delays and lead to failures in device certification and approval, particularly for small and medium-sized businesses, the resolution states. Politicians said the problems restrict patients’ access to life-saving technologies.

Other criticisms include the lack of harmonized procedures between notified bodies in the European Union. The situation has led to “unpredictable delays for certification and market access”, according to policy makers, as well as “inconsistency in decisions and a lack of transparency in the work of notified bodies”.

The resolution calls on the commission to propose acts that resolve the most pressing problems by the end of the first quarter of 2025. At the same time, politicians want the commission to propose systematic revisions of the regulation as soon as possible.

Specific ideas include a call to “resolve issues of divergent interpretation and practical application to streamline the regulatory process, improve transparency and eliminate unnecessary administrative work for notified bodies and manufacturers.” The resolution calls for “transparent and binding deadlines, including deadlines for the procedural stages of conformity assessment by notified bodies”.

Peter Liese, Member of Parliament, is one of the authors of the resolution. Liese argued for rapid changes to the regulations during a debate in Parliament in October. Believing that the new commission should act within 100 days, Liese called the regulation “a bureaucratic monster with a multitude of rules that do not increase safety, but increase costs.”

Parliament’s call for urgent action was welcomed by MedTech Europe, which put forward similar suggestions last week in a letter to Stella Kyriakides, the outgoing commissioner for health and food safety. MedTech Europe welcomed Parliament’s emphasis on predictability and the elimination of unnecessary administrative burdens, as well as the urgency of the call for change.

Věra Jourová, vice-president for values ​​and transparency at the commission, called for a measured approach to reform after hearing Liese call for rapid action during the recent debate in Parliament. Jourová warned against a hasty initiative. “We must achieve this based on data and analysis, as well as the necessary involvement of all relevant stakeholders. » » said Jourova.