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Last Call for Substance-Based Medical Devices under MDD

Last Call for Substance-Based Medical Devices under MDD

Mar 14, 2024 | a&r News, Regulatory

Certain substance-based medical devices that are not yet certified under the MDR may retain their market authorization under specific conditions until 31 December 2027, or even until 31 December 2028 (see the extended transition period defined in Article 120 of...
MDR transition period and deletion of the MDR/IVDR ‘sell-off dates’ officially implemented

MDR transition period and deletion of the MDR/IVDR ‘sell-off dates’ officially implemented

Mar 30, 2023 | Regulatory

Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices was published in the...
Medical Device Regulation Extension of transition period approved, but what are the implications?

Medical Device Regulation Extension of transition period approved, but what are the implications?

Feb 23, 2023 | Regulatory

In recent months, news about the Medical Device Regulation has accumulated. Last week, positive news emerged as European legislators yielded to industry pressure, agreeing to extend transition periods. This means you can keep your medical device, and with the new...
German Bundesrat: urgent need in the implementation of the MDR

German Bundesrat: urgent need in the implementation of the MDR

Oct 12, 2022 | Regulatory

a&r was approved as a company engaged in research and development, and therefore received the approval for the research tax credit from the French Ministry of Higher Education, Research and Innovation. The Research Tax Credit (CIR) is a tax measure of...
The lack of Notified Bodies might endanger the availability of medical devices

The lack of Notified Bodies might endanger the availability of medical devices

Sep 28, 2022 | Regulatory

a&r was approved as a company engaged in research and development, and therefore received the approval for the research tax credit from the French Ministry of Higher Education, Research and Innovation. The Research Tax Credit (CIR) is a tax measure of...

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  • Regulatory wrap up of the year 2024
  • Last Call for Substance-Based Medical Devices under MDD
  • EFSA released new guidance on novel foods
  • Meet a&r expert Dr. Heike Stier in Brussels
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