- July 26, 2023As of March 20, 2023, Regulation (EU) 2023/607 was published to smoothen the transition from MDD (and AIMDD) to MDR…
- March 29, 2023On 20 Mar. 2023, the European Commission published Regulation (EU) 2023/607 extending the transitional periods for devices requiring a Notified…
- March 13, 2023As of Dec. 1, 2022, the European Commission published the definitions of common specifications for the devices without a medical…
- February 16, 2023By today's publication in the official European database NANDO, the list of Notified Bodies under Regulation (EU) 2017/746 (IVDR) has…
- October 12, 2022With the position papers MDCG 2022-4 and MDCG 2022-15, Notified Bodies are requested to identify relevant certificates (under Directive 93/42/EEC…
- July 27, 2022Dear Sir or Madam, in December 2021, the German Institute for Standardisation (DIN) published the new edition of DIN EN…
July 24, 2022On 24 July, 2022 we celebrated the official opening of our Israel Branch Office in Haifa. Elias Daher, the Head…- June 26, 2022In the new position paper MDCG 2022-11, which has been published by the European Commission, manufacturers are requested to submit…
- February 7, 2022By Regulation (EU) 2022/112, the EU has amended the transition provisions for certain in-vitro diagnostic medical devices and postponed the…
- January 3, 2022Just in time with respect to the date of application of the third generation of the Technical Cooperation Programme on…
