MedtecLIVE | Regulation
medical device

Regulation

Whether European Medical Device Regulation (MDR) or other international regulations. For the medical technology industry, it is important to keep an eye on the latest developments in regulations

The threat of a medical device shortage on 27.5.2024 seems to have been averted. The EU is extending the deadlines for the introduction of the Medical Device Regulation (MDR). Nevertheless, the implementation of the MDR has been proceeding slowly since it came into force, and the European regulations from the MDR and IVDR have been a source of much discussion since then.

However, manufacturers who want to export must not lose sight of the regulations of the American FDA or the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). After all, Asia and North America are known as growth markets in medical technology.

 

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To the other focus topics

Circuit boards with electronic components

Digitalisation

The digitalisation of healthcare and industrial manufacturing offers plenty of new opportunities - for patients as well as for traditional and new players on the market.

Prosthetic arm and arm join hands

Production of the future

Hardly any medical technology product is manufactured in very large quantities today. New processes must therefore be able to realise high efficiency in production and high customisability at the same time.

medical device

Transformation

Due to its growth potential, the medical technology market is attractive for many manufacturing companies that are still active in other industries today.