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WORKING GROUP ON NEW AND EMERGING TECHNOLOGIES IN MEDICAL

WORKING GROUP ON NEW AND EMERGING TECHNOLOGIES IN MEDICAL 2025

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The document is a report from the Working Group on New and Emerging Technologies in Medical Devices, focusing on the implications of nanotechnology in medical devices. It outlines the scope, aims, and findings regarding the adequacy of existing medical device regulations to address risks associated with nanotechnology. The report concludes that current legislation is generally suitable but recommends specific classification rules for high-risk nanotechnology applications, development of regulatory guidance, and establishment of voluntary reporting schemes to enhance risk assessment and management.

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Who regulates medical devices in the EU?

In the European Union (EU) they must undergo a conformity assessment to demonstrate they meet legal requirements to ensure they are safe and perform as intended. They are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process.

What is CE certification for medical devices?

CE marking is the medical device manufacturers claim that a product meets the General Safety and Performance Requirements (GSPR) of all relevant European Medical Device Regulations and is a legal requirement to place a device on the market in the European Union.

What is the medical device coordination group of the European Commission?

Medical Device Coordination Group - MDCG The MDCG advises and assists the Commission and EU countries in the implementation of both Regulations. The MDCG operates in ance with the horizontal rules on the creation and operation of Commission expert groups .

Which technology is best in the medical field?

Below is a description of medical technology and a list of 12 technologies that are improving patient treatment and recovery and helping medical professionals excel in their careers. 3D Printing. Precision Medicine. CRISPR. Telemedicine. Health Wearables. Mental Health Technology. Robotics. Nanotechnology.

What is the European Commission a group of?

Organisation of the European Commission Under the leadership of its President, the Commissions work is steered by a group of 27 Commissioners, known as the College. Together they take decisions on the Commissions political and strategic direction. A new College of Commissioners is appointed every 5 years.

What is the role of the MDCG?

The Medical Device Coordination Group (MDCG) deals with key issues from the medical devices sector, from Notified Body oversight or standardisation to market surveillance, passing by international matters, new technologies and clinical investigation.

WORKING GROUP ON NEW AND EMERGING TECHNOLOGIES IN MEDICAL 2025

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