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...
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...
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...
Dec 21, 2022 | Regulatory
Good news for manufacturers of medical devices still marketed under a Medical Device Directive (MDD) certificate: On Friday 9 December, the European Commission proposed a further extension of the MDR transition period the EPSCO meeting in Brussels. The proposed...
Nov 29, 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...
