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ATLAS DENTAL Special Edition IDS 2025

Markets in Europe and overseas /// Structures, challenges and opportunities

M 96 Chapters
ATLAS DENTAL Special Edition IDS 2025

The study examines important European markets in the dental healthcare industry and takes a look at trends and developments overseas. On 72 pages, ATLAS DENTAL offers a comprehensive comparison of These markets based on structural profiles, informative texts and illustrative.

Close
ATLAS DENTAL Special Edition IDS 2025

The study examines important European markets in the dental healthcare industry and takes a look at trends and developments overseas. On 72 pages, ATLAS DENTAL offers a comprehensive comparison of These markets based on structural profiles, informative texts and illustrative.

Close

3.4.3  Manufacturer/retailer

While EU countries have harmonized their regulatory requirements for medical devices through the MDR, requirements and approval procedures for medical devices intended for markets outside the EU differ significantly depending on the target country. However, the basic principles such as conformity assessment, quality management requirements and the classification of medical devices are mostly similar. There are also international organizations such as the International Medical Device Regulators Forum, which promotes cooperation between many countries in order to harmonize regulations and reduce market barriers.297

Market access for medical devices in the European Union

When it came into force in May 2017, the MDR replaced the old legal provisions for medical devices and has kept the industry busy since it came into force in May 2021 at the latest. Since then, medical devices may only be placed on the market in accordance with the new provisions. In particular, the fact that all medical devices that have already been approved (legacy devices) must also be recertified in accordance with the new requirements is causing bottlenecks. For this reason, the European Commission has set transitional periods that expire in stages in 2023, depending on the risk class of the medical devices.

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