MDR Archives - Medical Design Sourcing

Alarming results and some good news from MDR and IVDR survey of notified bodies

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By Annette Van Raamsdonk and Evangeline Loh, Emergo by UL

The European Commission (EC) posted a July 25 update on the current state of Medical Devices Regulation (2017/745 MDR) and In Vitro Diagnostics Devices Regulation (2017/746 IVDR) applications.

The data collected was from a recent survey instrument intended to monitor and analyze the availability of devices on the EU market.

Study on medical devices and Notified Body survey instrument

The study was led by Gesundheit Österreich GmbH (Austrian National Public Health Institute) with Areté and Civic Consulting. The study started in December 2022 and will end in 2025.

The survey instrument to collect the most recent data on certificates issued and the number of applications received was shared with the Notified Bodies on April 3, 2023, and concluded May 5, 2023.

The collected data have been compared with data…

MDR transition delay approved by European Parliament and Council

EU Commissioner for Health and Food Safety Stella Kyriakides [Photo courtesy of the European Commission]

The European Parliament and Council today voted to approve a Medical Devices Regulation (MDR) transition delay in an effort to avoid shortages.

The move gives medical device manufacturers more time to certify their devices under the new MDR rules.

“I welcome today’s [European Parliament] vote to extend the transition period to new rules under the Medical Devices Regulation,” Commissioner for Health and Food Safety Stella Kyriakides said. “This will help give clarity to manufacturers and ensure that patients can access the essential medical devices they need. This is our top priority.”

The delay does not modify MDR’s current safety and performance requirements. Instead, it gives manufacturers more time to move from the old rules to the new requirements.

It al…

European Commission endorses MDR transition delay

EU Commissioner for Health and Food Safety Stella Kyriakides [Photo courtesy of the European Commission]

An MDR transition delay is one step closer to reality following concerns that the current timeline could lead to medical device shortages.

The European Commission on Jan. 6 officially endorsed a proposal to give medical device manufacturers more time to certify their devices under new Medical Devices Regulation (MDR) rules. The proposed MDR transition delay will not become official without approval by the European Parliament and Council.

The proposal would not change any of MDR’s current safety and performance requirements. Instead, it would give manufacturers more time to move from the old rules to the new requirements. It would remove the “sell-off” date and extend transition periods.

RELATED: Navigating MDR’s newly charted waters

MDR went into effect in May 2021 with…

Navigating MDR’s newly charted waters

Compliance with the EU’s MDR often requires multidisciplinary collaboration between a device maker’s operations, R&D, regulatory and quality teams, plus partners across the supply chain. [Photo courtesy of Avery Dennison Medical]

With the Medical Device Regulation in effect, European Union regulatory compliance requires rigorous attention and cross-functional collaboration.

Lisa Bartakovics, Avery Dennison Medical

Are you ready for MDR? That question has weighed on medical device manufacturers ever since the European Union proposed stronger device regulations and requirements.

After MDR became law in May 2017, the industry had four years to transition and comply. It’s been more than a year since MDR’s May 26, 2021, application date, yet there still is uncertainty regarding compliance requirements due to the lack of guidance documents and individual interpretation.

O…