Monday, October 28, 2024

Regulation of LDT's in Europe: Reports Say It's a Mess

As the FDA moves towards a massive new regulation of LDT tests in the USA, many are keeping one eye on a similar process underway in Europe.

Latest reports are: It's a mess.

See a Linked In post from Michelle Lott, a regulatory consultant:

https://www.linkedin.com/posts/michellelottraqa_medicaldevices-qualitymanagement-compliance-activity-7256655034258464769-2q_Y/

Lott writes,

The European Parliament has issued an urgent resolution calling for the revision of MDR.  It's a blistering diatribe, calling out the complexity of the certification process, the timelines extensions for both MDR and IVDR (which have accomplished next to nothing), the lack of harmonized processes across notified bodies, EUDAMED delays, the lack of transparency in NB fee structures, unnecessary re-certification of some devices and more. 

This resolution calls for the European Commission to propose "π‘‘π‘’π‘™π‘’π‘”π‘Žπ‘‘π‘’π‘‘ π‘Žπ‘›π‘‘ π‘–π‘šπ‘π‘™π‘’π‘šπ‘’π‘›π‘‘π‘–π‘›π‘” π‘Žπ‘π‘‘π‘  π‘‘π‘œ π‘‘β„Žπ‘’ 𝑀𝐷𝑅 π‘Žπ‘›π‘‘ π‘‘β„Žπ‘’ 𝐼𝑉𝐷𝑅 π‘‘π‘œ π‘Žπ‘‘π‘‘π‘Ÿπ‘’π‘ π‘  π‘‘β„Žπ‘’ π‘šπ‘œπ‘ π‘‘ π‘π‘Ÿπ‘’π‘ π‘ π‘–π‘›π‘” π‘β„Žπ‘Žπ‘™π‘™π‘’π‘›π‘”π‘’π‘  π‘Žπ‘›π‘‘ π‘π‘œπ‘‘π‘‘π‘™π‘’π‘›π‘’π‘π‘˜π‘  𝑖𝑛 π‘‘β„Žπ‘’ π‘–π‘šπ‘π‘™π‘’π‘šπ‘’π‘›π‘‘π‘Žπ‘‘π‘–π‘œπ‘› π‘œπ‘“ π‘‘β„Žπ‘’ π‘™π‘’π‘”π‘–π‘ π‘™π‘Žπ‘‘π‘–π‘£π‘’ π‘“π‘Ÿπ‘Žπ‘šπ‘’π‘€π‘œπ‘Ÿπ‘˜π‘  π‘Žπ‘›π‘‘ π‘‘π‘œ π‘π‘Ÿπ‘œπ‘π‘œπ‘ π‘’ π‘‘β„Žπ‘’ π‘ π‘¦π‘ π‘‘π‘’π‘šπ‘Žπ‘‘π‘–π‘ π‘Ÿπ‘’π‘£π‘–π‘ π‘–π‘œπ‘› π‘œπ‘“ π‘Žπ‘™π‘™ π‘Ÿπ‘’π‘™π‘’π‘£π‘Žπ‘›π‘‘ π‘Žπ‘Ÿπ‘‘π‘–π‘π‘™π‘’π‘  π‘œπ‘“ π‘‘β„Žπ‘’π‘ π‘’ π‘Ÿπ‘’π‘”π‘’π‘™π‘Žπ‘‘π‘–π‘œπ‘›π‘ , π‘Žπ‘π‘π‘œπ‘šπ‘π‘Žπ‘›π‘–π‘’π‘‘ 𝑏𝑦 π‘Žπ‘› π‘–π‘šπ‘π‘Žπ‘π‘‘ π‘Žπ‘ π‘ π‘’π‘ π‘ π‘šπ‘’π‘›π‘‘, π‘‘π‘œ 𝑏𝑒 π‘π‘œπ‘›π‘‘π‘’π‘π‘‘π‘’π‘‘ π‘Žπ‘  π‘ π‘œπ‘œπ‘› π‘Žπ‘  π‘π‘œπ‘ π‘ π‘–π‘π‘™π‘’" by the end of Q1 2025.

Lott links to the underlying 5-page document from the European Parliament:

https://www.europarl.europa.eu/doceo/document/TA-10-2024-0028_EN.pdf

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AI Corner

Here's a brief synopsis via Chat GPT 4o:

The recent European Parliament resolution emphasizes a critical and chaotic situation surrounding medical device regulations (MDR) and in vitro diagnostic regulations (IVDR) in the EU. The resolution, acknowledging ongoing delays and certification bottlenecks, urgently calls for regulatory overhaul to avoid significant disruptions in device availability. Small and medium-sized enterprises (SMEs), which form a large portion of the sector, face insurmountable regulatory and financial hurdles, limiting their ability to bring essential devices to market and impacting patient access across the EU. The Parliament highlights the need for streamlined procedures, standardized timelines, and support mechanisms, particularly for innovative and pediatric medical devices.

Key recommendations include implementing fast-track pathways, transparent and fair fee structures, and a harmonized approach to ensure access to life-saving devices. The lack of consistent certification processes and harmonized policies across member states is creating unpredictability, increasing costs, and placing patient safety and access at risk. The European Parliament urges the European Commission to act swiftly, ideally by Q1 2025, to provide a comprehensive revision, transparent timelines, and support measures for SMEs. These steps aim to prevent device shortages, protect patient safety, and improve transparency and efficiency, addressing what many see as a crisis-level disruption in EU healthcare delivery.