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US tariffs on medical devices: What manufacturers need to consider now
US tariffs on medical devices: What manufacturers need to consider now On April 9, 2025, the U.S. government unexpectedly announced a 90-day pause in tariffs. While for most countries ...
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MDR/IVDR, AI Act & data protection - the magic triangle
Regulatory overlaps in medical technology: MDR/IVDR, AI Act and data protection in focus The integration of artificial intelligence (AI) into medical devices opens up new possibilities - but ...
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Regulatory resilience as a success factor
Regulatory resilience as a success factor for global market access of medical devices In an increasingly complex regulatory landscape, manufacturers of medical devices are faced with the challenge of improving their market access strategies ...
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QMSR replaces QSR: What medical device manufacturers need to know now
QMSR replaces QSR: What medical device manufacturers need to know now From February 2, 2026, a new regulatory framework for quality systems will apply in the USA: The previous ...
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Medtech market 2025: How manufacturers can remain successful
Medtech market 2025: trends, challenges and how manufacturers can remain successful The medical technology industry in Germany is facing a challenging year in 2025. While the economic situation is expected to ...
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MDR Ready? - What importers and retailers need to consider
MDR Ready - What importers and distributors need to consider now Regulation (EU) 2017/745 (Medical Device Regulation, MDR) has been in force since May 26, 2021.
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Spain Medical device registration
National requirements for the approval of medical devices in Spain Spain is one of the largest markets for medical technology in Europe and, as an EU member state, is subject to the Medical Device Regulation ...
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France Medical device registration
National requirements for the approval of medical devices in France France is one of the most important markets for medical technology in Europe. Medical devices are approved in accordance with ...
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Germany Medical device registration
National requirements for the approval of medical devices in Germany Germany is one of the largest medical technology markets in the world and, as an EU member state, is subject to the requirements of the Medical Device Regulation (MDR ...
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European Economic Area Medical device registration
Approval of medical devices in Europe - A guide for manufacturers The approval of medical devices in Europe is governed by the Medical Device Regulation (MDR 2017/745) ...
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USA Medical device registration
Approval of medical devices in the USA - A guide for manufacturers The USA is the largest market for medical devices in the world. Manufacturers who sell their products in ...
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Brazil Medical device registration
Approval of medical devices in Brazil - A guide for manufacturers Brazil is the largest medical technology market in South America and is subject to strict regulatory requirements. Manufacturers who ...
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Italy Medical device registration
Approval of medical devices in Italy - A guide for manufacturers The approval of medical devices in Italy is based on the European Medical Device Regulation (MDR 2017/745) and ...
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UK medical device registration
Approval of medical devices in the United Kingdom - A guide for manufacturers Following Brexit, the United Kingdom has established an independent regulatory system for medical devices. ...
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